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1.  Does chocolate reduce blood pressure? A meta-analysis 
BMC Medicine  2010;8:39.
Dark chocolate and flavanol-rich cocoa products have attracted interest as an alternative treatment option for hypertension, a known risk factor for cardiovascular disease. Previous meta-analyses concluded that cocoa-rich foods may reduce blood pressure. Recently, several additional trials have been conducted with conflicting results. Our study summarises current evidence on the effect of flavanol-rich cocoa products on blood pressure in hypertensive and normotensive individuals.
We searched Medline, Cochrane and international trial registries between 1955 and 2009 for randomised controlled trials investigating the effect of cocoa as food or drink compared with placebo on systolic and diastolic blood pressure (SBP/DBP) for a minimum duration of 2 weeks. We conducted random effects meta-analysis of all studies fitting the inclusion criteria, as well as subgroup analysis by baseline blood pressure (hypertensive/normotensive). Meta-regression analysis explored the association between type of treatment, dosage, duration or baseline blood pressure and blood pressure outcome. Statistical significance was set at P < 0.05.
Fifteen trial arms of 13 assessed studies met the inclusion criteria. Pooled meta-analysis of all trials revealed a significant blood pressure-reducing effect of cocoa-chocolate compared with control (mean BP change ± SE: SBP: -3.2 ± 1.9 mmHg, P = 0.001; DBP: -2.0 ± 1.3 mmHg, P = 0.003). However, subgroup meta-analysis was significant only for the hypertensive or prehypertensive subgroups (SBP: -5.0 ± 3.0 mmHg; P = 0.0009; DBP: -2.7 ± 2.2 mm Hg, P = 0.01), while BP was not significantly reduced in the normotensive subgroups (SBP: -1.6 ± 2.3 mmHg, P = 0.17; DBP: -1.3 ± 1.6 mmHg, P = 0.12). Nine trials used chocolate containing 50% to 70% cocoa compared with white chocolate or other cocoa-free controls, while six trials compared high- with low-flavanol cocoa products. Daily flavanol dosages ranged from 30 mg to 1000 mg in the active treatment groups, and interventions ran for 2 to 18 weeks. Meta-regression analysis found study design and type of control to be borderline significant but possibly indirect predictors for blood pressure outcome.
Our meta-analysis suggests that dark chocolate is superior to placebo in reducing systolic hypertension or diastolic prehypertension. Flavanol-rich chocolate did not significantly reduce mean blood pressure below 140 mmHg systolic or 80 mmHg diastolic.
PMCID: PMC2908554  PMID: 20584271
2.  The Role of the Endogenous Antioxidant Enzymes and Malondialdehyde in Essential Hypertension 
Context: Oxidative Stress is caused by an imbalance between the production of reactive oxygen species and a biological system’s ability to readily detoxify the reactive intermediates.
Aims: 1. To compare the levels of Malondialdehyde (MDA), in hypertensive and normotensive subjects.
2. To compare the levels of the antioxidant enzymes, namely, Catalase, Glutathione peroxidase (GPX) and Superoxide Dismutase (SOD) in hypertensive and normotensive subjects.
3. To determine the correlation between the MDA levels and the mean arterial pressure (MAP) among hypertensive subjects.
4. To determine the correlation between the antioxidant enzyme levels and MAP among the hypertensive subjects and to evaluate the effect of 6 months of antihypertensive therapy with a tight blood pressure control on the MDA levels.
Materials and Methods : In this cross sectional study, 25 normotensive and 40 hypertensive subjects were recruited. The hypertensive subjects were further subdivided into three subgroups: Prehypertensives, Stage I hypertensives and Stage II hypertensives. All the subjects underwent a blood pressure measurement and the markers of oxidative stress in their sera were estimated. The subjects of Stage I hypertension and Stage II hypertension were given antihypertensive treatment for 6 months and their blood pressures were tightly regulated and brought to the normotensive state. After 6 months, the estimations of the markers of oxidative stress were done again.
Results: The MDA levels were significantly increased in the stage I and stage II hypertension groups as compared to those of the control group (p<0.05). The antioxidant enzymes (SOD, Catalase and GPX) were significantly decreased (p<0.05) in the prehypertension and in the stage I and stage II hypertension groups as compared to those in the control group. There was a significant increase in the levels of the antioxidant enzymes after 6 months of a tight regulation and bringing of the blood pressure to the normotensive state by giving antihypertensive therapy.
Conclusion: On comparison of the present study with other studies in which the use of antioxidants were found to be ineffective in the blood pressure reduction, it can be concluded that oxidative stress is an effect rather than a cause of essential hypertension.
PMCID: PMC3708256  PMID: 23905086
Essential hypertension; Oxidative Stress; Catalase; Glutathione peroxidase; Superoxide Dismutase Antihypertensive therapy
3.  A school-based physical activity program to improve health and fitness in children aged 6–13 years ("Kinder-Sportstudie KISS"): study design of a randomized controlled trial [ISRCTN15360785] 
BMC Public Health  2006;6:147.
Childhood obesity is the result of a long lasting imbalance between energy intake and energy expenditure. A major contributing factor is physical inactivity which is closely linked to bone health, cardiovascular disease risk, fitness and psychological factors. The school seems to provide an excellent setting to enhance levels of physical activity (PA). However, there is insufficient data from previous school-based intervention trials on how to enhance overall PA. It is also unknown whether an intervention aimed at increasing PA is effective in improving the children's health. The purpose of this paper is to outline the design of a school-based randomized, controlled trial (RCT) aiming to increase overall PA and to improve fitness and health in 6- to 13-year-old children.
15 schools were randomized to the intervention (n = 9) or the control (n = 6) group, stratified by geographic region (urban vs. rural) and by age (1st and 5th grade). Participation was given for all children in the intervention group since in this group the intervention was part of the normal school curriculum. The intervention during one academic year consisted of: 1. two additional physical education classes per week given by trained physical education teachers adding up to a total of five PA classes per week, 2. short PA breaks (2–5 min each) during academic lessons, 3. PA home work, and 4. adaptation of recreational areas around the school. All children underwent anthropometric measurements, blood pressure assessment, fitness testing, measurement of PA and they filled out questionnaires. At least 70% of all children agreed to blood sampling and measurements of body composition and bone mineral measurements by dual energy x-ray absorptiometry. The primary endpoints of the study after one year were an increase in total PA by accelerometry, an increase in aerobic fitness measured by the 20 m shuttle run, a decrease in percent body fat derived from skinfold measurements and an increase in quality of life as assessed by the child health questionnaire in the intervention group compared to the control group. Secondary outcomes were overall fitness, differences in body composition including body fat distribution, cardiovascular risk factors, psychosocial health, bone mineral content and density of femur, lumbar spine and total body and food intake.
Our preliminary data suggest that the children were representative of Swiss children with respect to sex, socio-demographic status, and body mass index. Short-term results can be expected by the beginning of 2007. We hypothesized that our intervention will lead to an increase in PA, fitness and overall health. Based on our data, we aim to provide important information regarding the influence of such an intervention on these outcome measures in school-aged children and to provide nationwide guidelines to improve PA in children.
PMCID: PMC1513202  PMID: 16756652
4.  Systematic review of long term effects of advice to reduce dietary salt in adults 
BMJ : British Medical Journal  2002;325(7365):628.
To assess the long term effects of advice to restrict dietary sodium in adults with and without hypertension.
Systematic review and meta-analysis of randomised controlled trials.
Data sources
Cochrane library, Medline, Embase, and bibliographies.
Study selection
Unconfounded randomised trials that aimed to reduce sodium intake in healthy adults over at least 6 months. Inclusion decisions, validity and data extraction were duplicated. Random effects meta-analysis, subgrouping, sensitivity analysis, and meta-regression were performed.
Mortality, cardiovascular events, blood pressure, urinary sodium excretion, quality of life, and use of antihypertensive drugs.
Three trials in normotensive people (n=2326), five trials in those with untreated hypertension (n=387), and three trials in people being treated for hypertension (n=801) were included, with follow up from six months to seven years. The large high quality (and therefore most informative) studies used intensive behavioural interventions. Deaths and cardiovascular events were inconsistently defined and reported. There were 17 deaths, equally distributed between intervention and control groups. Systolic and diastolic blood pressures were reduced (systolic by 1.1 mm Hg, 95% confidence interval 1.8 to 0.4 mm Hg; diastolic by 0.6 mm Hg, 1.5 to −0.3 mm Hg) at 13 to 60 months, as was urinary 24 hour sodium excretion (by 35.5 mmol/24 hours, 47.2 to 23.9). Degree of reduction in sodium intake and change in blood pressure were not related.
Intensive interventions, unsuited to primary care or population prevention programmes, provide only small reductions in blood pressure and sodium excretion, and effects on deaths and cardiovascular events are unclear. Advice to reduce sodium intake may help people on antihypertensive drugs to stop their medication while maintaining good blood pressure control.
What is already known on this topicRestricting sodium intake in people with hypertension reduces blood pressureLong term effects (on blood pressure, mortality, and morbidity) of reduced salt intake in people with and without hypertension are unclearWhat this study addsFew deaths and cardiovascular events have been reported in salt reduction trialsMeta-analysis shows that blood pressure was reduced (systolic by 1.1 mm Hg, diastolic by 0.6 mm Hg) at 13 to 60 months, with a reduction in sodium excretion of almost a quarter (35.5 mmol/24 hours)The interventions used were highly intensive and unsuited to primary care or population prevention programmesLower salt intake may help people on antihypertensive drugs to stop their medication while maintaining good control of blood pressure, but there are doubts about effects of sodium reduction on overall health
PMCID: PMC126303  PMID: 12242173
5.  A randomised trial of a 5 week, manual based, self-management programme for hypertension delivered in a cardiac patient club in Shanghai 
In Shanghai there are 1.2 million people with hypertension, many of whom have difficulty in affording medical treatment. Community based, anti-hypertensive clubs have been created to provide health education but education alone is often ineffective. Lifestyle change programmes have shown some potential for reducing blood pressure but in previous trials have required specialist staff and extensive contact. We have previously demonstrated that self-management programmes delivered by health professionals, such as a nurse who has had short training in self-management techniques can change health behaviour and reduce symptoms. This study was designed to evaluate the benefits of a simple, cognitive-behavioural, self-management programme for hypertension based around a hypertension manual and delivered in the setting of a community anti-hypertensive club in Shanghai.
The method was a pragmatic randomised controlled trial with an intention-to-treat analysis. Adult patients with mild-to-moderate primary hypertension, waiting to join a neighbourhood anti-hypertension club, were randomised to the self-management programme or to an information only control procedure. They attended the group treatment sessions on 4 occasions over 5 weeks for education combined with goal setting for lifestyle change and an introduction to exercise. The main outcome measures were: changes in blood pressure; blood total cholesterol; diet; activity level and health related quality of life 1 month and 4 months after the end of treatment.
A total of 140 adults with mild-to-moderate primary hypertension took part. All of the main outcomes showed beneficial changes. Four months after the end of treatment the mean blood pressure differences between groups were systolic 10.15 mm Hg (P < 0.001, 95% CI 7.25–13.05), and diastolic 8.29 mmHg (P < 0.001, 95% CI 6.71–9.88). Patients in the intervention group also had significantly reduced weight, lowered blood total cholesterol, increased physical activity and improved quality of life.
Patients with mild-to-moderate primary hypertension attending a 5 week, group and manual based, cognitive-behavioural self-management programme, delivered through a voluntary club in Shanghai experienced a significant reduction in blood pressure.
Trial registration
Current Controlled Trials ISRCTN73114566
PMCID: PMC2412838  PMID: 18460201
6.  Effect of school based physical activity programme (KISS) on fitness and adiposity in primary schoolchildren: cluster randomised controlled trial 
Objective To assess the effectiveness of a school based physical activity programme during one school year on physical and psychological health in young schoolchildren.
Design Cluster randomised controlled trial.
Setting 28 classes from 15 elementary schools in Switzerland randomly selected and assigned in a 4:3 ratio to an intervention (n=16) or control arm (n=12) after stratification for grade (first and fifth grade), from August 2005 to June 2006.
Participants 540 children, of whom 502 consented and presented at baseline.
Intervention Children in the intervention arm (n=297) received a multi-component physical activity programme that included structuring the three existing physical education lessons each week and adding two additional lessons a week, daily short activity breaks, and physical activity homework. Children (n=205) and parents in the control group were not informed of an intervention group. For most outcome measures, the assessors were blinded.
Main outcome measures Primary outcome measures included body fat (sum of four skinfolds), aerobic fitness (shuttle run test), physical activity (accelerometry), and quality of life (questionnaires). Secondary outcome measures included body mass index and cardiovascular risk score (average z score of waist circumference, mean blood pressure, blood glucose, inverted high density lipoprotein cholesterol, and triglycerides).
Results 498 children completed the baseline and follow-up assessments (mean age 6.9 (SD 0.3) years for first grade, 11.1 (0.5) years for fifth grade). After adjustment for grade, sex, baseline values, and clustering within classes, children in the intervention arm compared with controls showed more negative changes in the z score of the sum of four skinfolds (−0.12, 95 % confidence interval −0.21 to −0.03; P=0.009). Likewise, their z scores for aerobic fitness increased more favourably (0.17, 0.01 to 0.32; P=0.04), as did those for moderate-vigorous physical activity in school (1.19, 0.78 to 1.60; P<0.001), all day moderate-vigorous physical activity (0.44, 0.05 to 0.82; P=0.03), and total physical activity in school (0.92, 0.35 to 1.50; P=0.003). Z scores for overall daily physical activity (0.21, −0.21 to 0.63) and physical quality of life (0.42, −1.23 to 2.06) as well as psychological quality of life (0.59, −0.85 to 2.03) did not change significantly.
Conclusions A school based multi-component physical activity intervention including compulsory elements improved physical activity and fitness and reduced adiposity in children.
Trial registration Current Controlled Trials ISRCTN15360785.
PMCID: PMC2827713  PMID: 20179126
7.  Exercise Training and Habitual Physical Activity A Randomized Controlled Trial 
Exercise training reduces adiposity and risk of cardiovascular disease. However, the combined effects of habitual free-living physical activity and aerobic training on waist circumference, weight, fitness, and blood pressure in postmenopausal women are unknown.
To evaluate the effects of habitual physical activity levels during aerobic training on weight, waist circumference, fitness, and blood pressure.
Secondary analysis of an RCT. Original data collected April 2001 to June 2005 and analyzed in 2012.
Postmenopausal women in a supervised exercise trial.
Women (n=325) were randomized to 4, 8, or 12 kcal per kg per week of aerobic training or a control group for 6 months. All outcome measures were collected at baseline and follow-up. Changes in dependent variables within each training group were evaluated across tertiles of pedometer-determined habitual physical activity outside exercise training sessions.
Main outcome measures
Changes in waist circumference and weight.
Reductions in waist circumference were significantly greater with higher steps/day accumulated outside exercise training compared to lower levels in the 4 (high: −4.8 cm vs low: −1.4 cm, p=0.03); 8 (high: −4.2 cm vs low: −0.4 cm, p=0.03), and 12 kcal per kg per week groups (high: −4.1 cm vs low: −0.7 cm, p=0.05). For all groups, p-trend < 0.03). A trend was observed for greater weight reduction with higher steps/day in the 4 kcal per kg per week group (p-trend= 0.04), but not for the other exercise doses. No effects were observed for blood pressure or fitness measures (all p>0.05).
In postmenopausal women, higher habitual physical activity while participating in aerobic training was associated with greater reductions in central adiposity, and was supportive of weight loss compared to lower levels.
PMCID: PMC3504348  PMID: 23159258
8.  Clinical Prediction in Early Pregnancy of Infants Small for Gestational Age by Customised Birthweight Centiles: Findings from a Healthy Nulliparous Cohort 
PLoS ONE  2013;8(8):e70917.
Small for gestational age (SGA) infants comprise up to 50% of all stillbirths and a minority are detected before birth. We aimed to develop and validate early pregnancy predictive models for SGA infants.
5628 participants from SCOPE, a prospective study of nulliparous pregnant women, were interviewed at 15±1 weeks’ gestation. Fetal anthropometry, uterine and umbilical Doppler studies were performed at 20±1 weeks’. The cohort was divided into training (n = 3735) and validation datasets (n = 1871). All-SGA (birthweight <10th customised centile), Normotensive-SGA (SGA with normotensive mother) and Hypertensive-SGA (SGA with mother who developed hypertension) were the primary outcomes. Multivariable analysis was performed using stepwise logistic regression firstly using clinical variables and then with clinical and ultrasound variables. Receiver operator curves were constructed and areas under the curve (AUC) calculated.
633 infants (11.3%) in the whole cohort were SGA; 465 (8.3%) Normotensive-SGA and 165 (3.0%) Hypertensive-SGA. In the training dataset risk factors for All-SGA at 15±1 weeks’ included: family history of coronary heart disease, maternal birthweight <3000 g and 3000 g to 3499 g compared with ≥3500 g, >12 months to conceive, university student, cigarette smoking, proteinuria, daily vigorous exercise and diastolic blood pressure ≥80. Recreational walking ≥4 times weekly, rhesus negative blood group and increasing random glucose were protective. AUC for clinical risk factors was 0.63. Fetal abdominal or head circumference z scores <10th centile and increasing uterine artery Doppler resistance at 20±1 weeks’ were associated with increased risk. Addition of these parameters increased the AUC to 0.69. Clinical predictors of Normotensive and Hypertensive-SGA were sub-groups of All-SGA predictors and were quite different. The combined clinical and ultrasound AUC for Normotensive and Hypertensive-SGA were 0.69 and 0.82 respectively.
Predictors for SGA of relevance to clinical practice were identified. The identity and predictive potential differed in normotensive women and those who developed hypertension.
PMCID: PMC3733741  PMID: 23940665
9.  Relaxation therapy and continuous ambulatory blood pressure in mild hypertension: a controlled study. 
BMJ : British Medical Journal  1990;300(6736):1368-1372.
OBJECTIVE--To determine the long term effects of relaxation therapy on 24 hour ambulatory intra-arterial blood pressure in patients with mild untreated and uncomplicated hypertension. DESIGN--Four week screening period followed by randomisation to receive either relaxation therapy or non-specific counselling for one year. Ambulatory intra-arterial blood pressure was measured before and after treatment. SETTING--Outpatient clinic in Amsterdam's university hospital. SUBJECTS--35 Subjects aged 20-60 who were being treated by general practitioners for hypertension but were referred to take part in the study. At three consecutive screening visits all subjects had a diastolic blood pressure without treatment of 95-110 mm Hg. Subjects were excluded if they had damaged target organs, secondary hypertension, diabetes mellitus, a cholesterol concentration greater than 8 mmol/l, or a history of malignant hypertension. INTERVENTIONS--The group allocated to relaxation therapy was trained for eight weeks (one hour a week) in muscle relaxation, yoga exercises, and stress management and continued exercising twice daily for one year with monthly visits to the clinic. The control group had the same attendance schedule but had no training and were requested just to sit and relax twice a day. All subjects were asked not to change their diet or physical activity. MAIN OUTCOME MEASURE--Changes in ambulatory intra-arterial blood pressure after one year of relaxation therapy or non-specific counselling. RESULTS--Mean urinary sodium excretion, serum concentration of cholesterol, and body weight did not change in either group. Diastolic pressures measured by sphygmomanometry were 2 and 3 mm Hg lower in subjects in the relaxation group and control group respectively at the one year follow up compared with initial readings. The mean diastolic ambulatory intra-arterial pressure during the daytime had not changed after one year in either group, but small treatment effects could not be excluded: the mean change for the relaxation group was -1 mm Hg (95% confidence interval -6 to 3.9 mm Hg) and for the control group -0.4 mm Hg (-5.3 to 4.6 mm Hg). Mean ambulatory pressure in the evening also had not changed over the year, and in both groups nighttime pressure was 5 mm Hg higher. The variability in blood pressure was the same at both measurements. CONCLUSIONS--Relaxation therapy was an ineffective method of lowering 24 hour blood pressure, being no more beneficial than non-specific advice, support, and reassurance--themselves ineffective as a treatment for hypertension.
PMCID: PMC1662994  PMID: 2196946
10.  Insulin resistance in offspring of hypertensive parents. 
BMJ : British Medical Journal  1993;307(6896):92-96.
OBJECTIVE--To determine if insulin resistance is present in normotensive adults at increased risk of developing hypertension. DESIGN--Normotensive subjects with at least one hypertensive parent were paired with offspring of normotensive parents (controls), being matched for age, sex, social class, and physical activity. SETTING--Outpatient clinic. SUBJECTS--30 paired subjects (16 men and 14 women) with and without a family history of hypertension, aged 18-32, with a body mass index < 25 kg/m2, with blood pressure < 130/85 mm Hg, and not taking drugs. INTERVENTIONS--Euglycaemic glucose clamp (two hour infusion of insulin 1 mU/kg/min) and intravenous glucose tolerance test (injection of 100 ml 20% glucose). MAIN OUTCOME MEASURES--Insulin mediated glucose disposal and insulin secretion. RESULTS--The offspring of hypertensive parents had slightly higher blood pressure than did the controls (mean 117 (SD 6) v 108 (5) mm Hg systolic, p = 0.013; 76 (7) v 67 (6) mm Hg diastolic, p = 0.017). Their insulin mediated glucose disposal was lower than that of controls (29.5 (6.5) v 40.1 (8.6) mumol/kg/min, p = 0.002), but, after adjustment for blood pressure, the difference was not significant (difference 6.9 (95% confidence interval -1.5 to 15.3), p = 0.10). Insulin secretion in the first hour after injection of glucose was slightly but not significantly higher in the offspring of hypertensive patients (9320 (5484) v 6723 (3751) pmol.min/l). The two groups had similar concentrations of plasma glucose (5.2 (0.3) v 5.1 (0.4) mmol/l), serum cholesterol (4.4 (0.8) v 4.6 (0.8) mmol/l), serum triglyceride (0.89 (0.52) v 0.68 (0.27) mmol/l), and serum low density lipoprotein cholesterol (2.81 (0.65) v 2.79 (0.61) mmol/l). The offspring of hypertensive parents, however, had lower serum concentrations of high density lipoprotein cholesterol (1.24 (0.31) v 1.56 (0.35) mmol/l, p = 0.002) and higher serum concentrations of non-esterified fatty acids (0.7 (0.4) v 0.4 (0.4) mmol/l, p = 0.039). CONCLUSIONS--Young normotensive subjects who are at increased risk of developing hypertension are insulin resistant.
PMCID: PMC1693494  PMID: 8343735
11.  Attenuation of Exaggerated Exercise Blood Pressure Response in African-American Women by Regular Aerobic Physical Activity 
Ethnicity & disease  2005;15(4 Suppl 5):S5-10-3.
A hyperreactive blood pressure response to exercise is a predictor of developing hypertension. The present study determined the influence of physical activity on an exaggerated exercise blood pressure response (EEBPR) in normotensive African-American women.
We screened 36 women 18–26 years of age for EEBPR defined as a ≥50 mm Hg difference in systolic blood pressure at rest and during exercise at 50% peak oxygen uptake (VO2peak). Seven subjects demonstrated an EEBPR and participated in the study. Study participants trained for eight weeks on a bicycle ergometer at a work intensity of 70% VO2peak. Blood pressure, heart rate, cardiac output (CO), stroke volume (SV), and total peripheral vascular resistance (TPR) were determined at baseline and during submaximal exercise at power outputs of 30 W and 50% VO2peak. Subjects served as their own controls, and data were evaluated by using a paired t test at P<.05.
Effectiveness of the intervention was shown by a significantly greater VO2peak associated with significant decrements in systolic and mean arterial pressures at power outputs of 30 W and 50% VO2peak. A significant decrement in heart rate was observed during exercise at 30 W. Significant increments in CO and SV and decrement in TPR were found during exercise at 50% VO2peak.
The reduction in TPR associated with regular aerobic physical activity may attenuate the EEBPR and decrease the risk for hypertension in normotensive, young-adult, African-American women.
PMCID: PMC3166530  PMID: 16315376
Exercise; African-American Women; Blood Pressure
12.  Prevention through Activity in Kindergarten Trial (PAKT): A cluster randomised controlled trial to assess the effects of an activity intervention in preschool children 
BMC Public Health  2010;10:410.
Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent.
The design, curriculum, and evaluation strategy of a cluster randomised intervention study in preschool children are described in this manuscript. In the Prevention through Activity in Kindergarten Trial (PAKT), 41 of 131 kindergartens of Wuerzburg and Kitzingen, Germany, were randomised into an intervention and a control group by a random number table stratified for the location of the kindergarten in an urban (more than 20.000 inhabitants) or rural area. The aims of the intervention were to increase physical activity and motor skills in the participating children, and to reduce health risk factors as well as media use. The intervention was designed to involve children, parents and teachers, and lasted one academic year. It contained daily 30-min sessions of physical education in kindergarten based on a holistic pedagogic approach termed the "early psychomotor education". The sessions were instructed by kindergarten teachers under regular supervision by the research team. Parents were actively involved by physical activity homework cards. The kindergarten teachers were trained in workshops and during the supervision. Assessments were performed at baseline, 3-5 months into the intervention, at the end of the intervention and 2-4 months after the intervention. The primary outcomes of the study are increases in physical activity (accelerometry) and in motor skills performance (composite score of obstacle course, standing long jump, balancing on one foot, jumping sidewise to and fro) between baseline and the two assessments during the intervention. Secondary outcomes include decreases in body adiposity (BMI, skin folds), media use (questionnaire), blood pressure, number of accidents and infections (questionnaire), increases in specific motor skills (throwing, balancing, complex motor performance, jumping) and in flexibility.
If this trial proofs the effectiveness of the multilevel kindergarten based physical activity intervention on preschooler's activity levels and motor skills, the programme will be distributed nationwide in Germany.
Trial Registration Identifier: NCT00623844
PMCID: PMC2916900  PMID: 20624316
13.  Physical fitness training in Subacute Stroke (PHYS-STROKE) - study protocol for a randomised controlled trial 
Trials  2014;15:45.
Given the rising number of strokes worldwide, and the large number of individuals left with disabilities after stroke, novel strategies to reduce disability, increase functions in the motor and the cognitive domains, and improve quality of life are of major importance. Physical activity is a promising intervention to address these challenges but, as yet, there is no study demonstrating definite outcomes. Our objective is to assess whether additional treatment in the form of physical fitness-based training for patients early after stroke will provide benefits in terms of functional outcomes, in particular gait speed and the Barthel Index (co-primary outcome measures) reflecting activities of daily living (ADL). We will gather secondary functional outcomes as well as mechanistic parameters in an exploratory approach.
Our phase III randomised controlled trial will recruit 215 adults with moderate to severe limitations of walking and ADL 5 to 45 days after stroke onset. Participants will be stratified for the prognostic variables of “centre”, “age”, and “stroke severity”, and randomly assigned to one of two groups. The interventional group receives physical fitness training delivered as supported or unsupported treadmill training (cardiovascular active aerobic training; five times per week, over 4 weeks; each session 50 minutes; total of 20 additional physical fitness training sessions) in addition to standard rehabilitation treatment. The control intervention consists of relaxation sessions (non-cardiovascular active; five times per week week, over 4 weeks; each session 50 minutes) in addition to standard rehabilitation treatment. Co-primary efficacy endpoints will be gait speed (in m/s, 10 m walk) and the Barthel Index (100 points total) at 3 months post-stroke, compared to baseline measurements. Secondary outcomes include standard measures of quality of life, sleep and mood, cognition, arm function, maximal oxygen uptake, and cardiovascular risk factors including blood pressure, pulse, waist-to-hip ratio, markers of inflammation, immunity and the insulin-glucose pathway, lipid profile, and others.
The goal of this endpoint-blinded, phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes, and to elucidate the mechanisms underlying this intervention.
Trial registration
Registered in with the Identifier NCT01953549.
PMCID: PMC3922602  PMID: 24491065
14.  Blood pressure and effect of exercise in children before and after surgical correction of coarctation of aorta. 
British Heart Journal  1980;44(4):411-415.
Systolic blood pressure was measured at rest and during exercise in 43 children who had undergone operation for correction of coarctation of the aorta, five children awaiting surgery for coaractation, and 22 control children. Ages ranged from 2 to 15 years, mean 7-6 years. The mean blood pressure of children with coarctation in both the pre- and postoperative groups was significantly higher at rest than in the controls. Of 43 postoperative patients, 15 (35%) were hypertensive (systolic blood pressure more than 95th centile), and 12 of these had a gradient between the upper and lower limb. Seven of the 28 normotensive patients also had a gradient postoperatively. Exercise increased the blood pressure more in children with coarctation than in controls, but there was much individual variability and this difference was not significant. Some children with coarctation developed very high blood pressures on exercise, but this was not related to the presence of a gradient. The mean interval after operation was significantly shorter in the hypertensive group, independent of the age at operation. Hypertension with or without a gradient commonly persists despite apparent successful surgical correction, but exercise is of limited value in its assessment in this age group.
PMCID: PMC482420  PMID: 7426203
15.  Improving aerobic fitness in older adults 
Canadian Family Physician  2010;56(5):e191-e200.
To determine the effects of adding stages of change–based counseling to an exercise prescription for older, sedentary adults in family practice.
The Step Test Exercise Prescription Stages of change counseling study was a 12-month cluster randomized trial.
Forty family practices in 4 regions of Canada.
Healthy, community-dwelling men (48%) and women (52%) with a mean (SD) age of 64.9 (7.1) years (range 55 to 85 years). There were a total of 193 participants in the intervention group and 167 in the control group.
Intervention physicians were trained to deliver a tailored exercise prescription and a transtheoretical behaviour change counseling program. Control physicians were trained to deliver the exercise prescription alone.
Predicted cardiorespiratory fitness, measured by predicted maximal oxygen consumption (pVO2max), and energy expenditure, measured by 7-day physical activity recall.
Mean increase in pVO2max was significant for both the intervention (3.02 [95% confidence interval 2.40 to 3.65] mL/kg/min) and control (2.21 [95% confidence interval 1.27 to 3.15] mL/kg/min) groups at 12 months (P < .001); however, there was no difference between groups. Women in the intervention group improved their fitness significantly more than women in the control group did (3.20 vs 1.23 mL/kg/min). The intervention group had a 4–mm Hg reduction in systolic blood pressure, while the control group’s mean reduction was 0.4 mm Hg (P < .001). The mean (SD) energy expended significantly increased and was higher in the intervention group than in the control group (69.06 [169.87] kcal/d vs −6.96 [157.06] kcal/d, P < .006). Practice setting characteristics did not significantly affect the primary outcomes.
The Step Test Exercise Prescription Stages of change exercise and behavioural intervention improved fitness and activity and lowered systolic blood pressure across a range of Canadian practices, but this was not significantly different from the control group, which received only the exercise prescription. Women in the intervention group showed higher levels of fitness than women in the control group did; men in both groups showed similar improvement.
PMCID: PMC2868630  PMID: 20463260
16.  The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial 
BMC Public Health  2014;14(Suppl 3):S4.
Death rates due to hypertension in low and middle income countries are higher compared to high income countries. The present study is designed to combine life style modification and home blood pressure monitoring for control of hypertension in the context of low and middle income countries.
The study is a two armed, parallel group, un-blinded, cluster randomized controlled trial undertaken within lower income areas in Kuala Lumpur. Two housing complexes will be assigned to the intervention group and the other two housing complexes will be allocated in the control group. Based on power analysis, 320 participants will be recruited. The participants in the intervention group (n = 160) will undergo three main components in the intervention which are the peer support for home blood pressure monitoring, face to face health coaching on healthy diet and demonstration and training for indoor home based exercise activities while the control group will receive a pamphlet containing information on hypertension. The primary outcomes are systolic and diastolic blood pressure. Secondary outcome measures include practice of self-blood pressure monitoring, dietary intake, level of physical activity and physical fitness.
The present study will evaluate the effect of lifestyle modification and peer support home blood pressure monitoring on blood pressure control, during a 6 month intervention period. Moreover, the study aims to assess whether these effects can be sustainable more than six months after the intervention has ended.
PMCID: PMC4251131  PMID: 25436830
Lifestyle modification; self-blood pressure monitoring; hypertension; cluster randomized controlled trial; Malaysia
17.  24 hour blood pressure monitoring in healthy and hypertensive children. 
24 Hour ambulatory blood pressure monitoring (ABPM) was performed to provide data on the normal daily blood pressure of healthy schoolchildren and on patients with hypertension. The subjects studied were 123 healthy schoolchildren with a mean (SD) age of 12.5 (1.6) years (range 9.5-14.5 years), 24 children with borderline or mild hypertension, 17 with renal hypertension and normal renal function, 10 with chronic renal failure, and six with a renal allograft. In eight children with definite renal disease a second measurement was performed after treatment modification. The monitor used for ABPM was validated with a mercury column manometer. The mean (SD) of the signed differences of the blood pressure measured by the two methods was -0.19 (1.75) mmHg for the systolic and -0.21 (2.11) mmHg for the diastolic blood pressure (n = 60). Normal values for daytime and night time blood pressure were determined for those aged 10-14 years. The mean (SD) blood pressure of the 123 children was 109 (7)/66 (8) mmHg (systolic/diastolic) for the daytime and 96 (8)/52 (7) mmHg at night time. Of the 24 children with borderline or mild hypertension 14 had a raised blood pressure on ABPM. The circadian rhythm was disturbed in three children of this group. Even children with normal daytime blood pressure had significantly higher systolic blood pressure in the night when compared with the controls. The incidence of disturbed circadian rhythm was higher in the groups with renal hypertension (4/17 in the subgroup with normal renal function, 5/16 in the group with renal failure and/or transplantation). All children undergoing a second ABPM measurement had a lower average blood pressure after treatment adjustment. ABPM measurements were reproducible and accurate. The method provided new data on the physiological circadian variation of blood pressure in healthy children. It proved to be a helpful tool in the diagnosis of hypertension, particularly in the detection of cases of disturbance of the circadian rhythm of blood pressure pattern and individual adjustment of treatment.
PMCID: PMC1029706  PMID: 8129450
18.  Conventional versus automated measurement of blood pressure in primary care patients with systolic hypertension: randomised parallel design controlled trial 
Objective To compare the quality and accuracy of manual office blood pressure and automated office blood pressure using the awake ambulatory blood pressure as a gold standard.
Design Multi-site cluster randomised controlled trial.
Setting Primary care practices in five cities in eastern Canada.
Participants 555 patients with systolic hypertension and no serious comorbidities under the care of 88 primary care physicians in 67 practices in the community.
Interventions Practices were randomly allocated to either ongoing use of manual office blood pressure (control group) or automated office blood pressure (intervention group) using the BpTRU device. The last routine manual office blood pressure (mm Hg) was obtained from each patient’s medical record before enrolment. Office blood pressure readings were compared before and after enrolment in the intervention and control groups; all readings were also compared with the awake ambulatory blood pressure.
Main outcome measure Difference in systolic blood pressure between awake ambulatory blood pressure minus automated office blood pressure and awake ambulatory blood pressure minus manual office blood pressure.
Results Cluster randomisation allocated 31 practices (252 patients) to manual office blood pressure and 36 practices (303 patients) to automated office blood pressure measurement. The most recent routine manual office blood pressure (149.5 (SD 10.8)/81.4 (8.3)) was higher than automated office blood pressure (135.6 (17.3)/77.7 (10.9)) (P<0.001). In the control group, routine manual office blood pressure before enrolment (149.9 (10.7)/81.8 (8.5)) was reduced to 141.4 (14.6)/80.2 (9.5) after enrolment (P<0.001/P=0.01), but the reduction in the intervention group from manual office to automated office blood pressure was significantly greater (P<0.001/P=0.02). On the first study visit after enrolment, the estimated mean difference for the intervention group between the awake ambulatory systolic/diastolic blood pressure and automated office blood pressure (−2.3 (95% confidence interval −0.31 to −4.3)/−3.3 (−2.7 to −4.4)) was less (P=0.006/P=0.26) than the difference in the control group between the awake ambulatory blood pressure and the manual office blood pressure (−6.5 (−4.3 to −8.6)/−4.3 (−2.9 to −5.8)). Systolic/diastolic automated office blood pressure showed a stronger (P<0.001) within group correlation (r=0.34/r=0.56) with awake ambulatory blood pressure after enrolment compared with manual office blood pressure versus awake ambulatory blood pressure before enrolment (r=0.10/r= 0.40); the mean difference in r was 0.24 (0.12 to 0.36)/0.16 (0.07 to 0.25)). The between group correlation comparing diastolic automated office blood pressure and awake ambulatory blood pressure (r=0.56) was stronger (P<0.001) than that for manual office blood pressure versus awake ambulatory blood pressure (r=0.30); the mean difference in r was 0.26 (0.09 to 0.41). Digit preference with readings ending in zero was substantially reduced by use of automated office blood pressure.
Conclusion In compliant, otherwise healthy, primary care patients with systolic hypertension, introduction of automated office blood pressure into routine primary care significantly reduced the white coat response compared with the ongoing use of manual office blood pressure measurement. The quality and accuracy of automated office blood pressure in relation to the awake ambulatory blood pressure was also significantly better when compared with manual office blood pressure.
Trial registration Clinical trials NCT 00214053.
PMCID: PMC3034423  PMID: 21300709
19.  Determining how best to support overweight adults to adhere to lifestyle change: protocol for the SWIFT study 
BMC Public Health  2015;15:861.
Physical activity plays a critical role in health, including for effective weight maintenance, but adherence to guidelines is often poor. Similarly, although debate continues over whether a “best” diet exists for weight control, meta-analyses suggest little difference in outcomes between diets differing markedly in macronutrient composition, particularly over the longer-term. Thus a more important question is how best to encourage adherence to appropriate lifestyle change. While brief support is effective, it has on-going cost implications. While self-monitoring (weight, diet, physical activity) is a cornerstone of effective weight management, little formal evaluation of the role that self-monitoring technology can play in enhancing adherence to change has occurred to date. People who eat in response to hunger have improved weight control, yet how best to train individuals to recognise when true physical hunger occurs and to limit consumption to those times, requires further study.
SWIFT (Support strategies for Whole-food diets, Intermittent Fasting, and Training) is a two-year randomised controlled trial in 250 overweight (body mass index of 27 or greater) adults that will examine different ways of supporting people to make appropriate changes to diet and exercise habits for long-term weight control. Participants will be randomised to one of five intervention groups: control, brief support (monthly weigh-ins and meeting), app (use of MyFitnessPal with limited support), daily self-weighing (with brief monthly feedback), or hunger training (four-week programme which trains individuals to only eat when physically hungry) for 24 months. Outcome assessments include weight, waist circumference, body composition (dual-energy x-ray absorptiometry), inflammatory markers, blood lipids, adiponectin and ghrelin, blood pressure, diet (3-day diet records), physical activity (accelerometry) and aerobic fitness, and eating behaviour. SWIFT is powered to detect clinically important differences of 4 kg in body weight and 5 cm in waist circumference. Our pragmatic trial also allows participants to choose one of several dietary (Mediterranean, modified Paleo, intermittent fasting) and exercise (current recommendations, high-intensity interval training) approaches before being randomised to a support strategy.
SWIFT will compare four different ways of supporting overweight adults to lose weight while following a diet and exercise plan of their choice, an aspect we believe will enhance adherence and thus success with weight management.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12615000010594. Registered 8th January 2015.
PMCID: PMC4560866  PMID: 26341820
Obesity; Adherence; Mobile applications; Hunger; Self-weighing; Intermittent fasting; High-intensity interval training; Self-monitoring
20.  LEARN 2 MOVE 7-12 years: a randomized controlled trial on the effects of a physical activity stimulation program in children with cerebral palsy 
BMC Pediatrics  2010;10:77.
Regular participation in physical activities is important for all children to stay fit and healthy. Children with cerebral palsy have reduced levels of physical activity, compared to typically developing children. The aim of the LEARN 2 MOVE 7-12 study is to improve physical activity by means of a physical activity stimulation program, consisting of a lifestyle intervention and a fitness training program.
This study will be a 6-month single-blinded randomized controlled trial with a 6-month follow up. Fifty children with spastic cerebral palsy, aged 7 to 12 years, with Gross Motor Function Classification System levels I-III, will be recruited in pediatric physiotherapy practices and special schools for children with disabilities. The children will be randomly assigned to either the intervention group or control group. The children in the control group will continue with their regular pediatric physiotherapy, and the children in the intervention group will participate in a 6-month physical activity stimulation program. The physical activity stimulation program consists of a 6-month lifestyle intervention, in combination with a 4-month fitness training program. The lifestyle intervention includes counseling the child and the parents to adopt an active lifestyle through Motivational Interviewing, and home-based physiotherapy to practise mobility-related activities in the daily situation. Data will be collected just before the start of the intervention (T0), after the 4-month fitness training program (T4), after the 6-month lifestyle intervention (T6), and after six months of follow-up (T12). Primary outcomes are physical activity, measured with the StepWatch Activity Monitor and with self-reports. Secondary outcomes are fitness, capacity of mobility, social participation and health-related quality of life. A random coefficient analysis will be performed to determine differences in treatment effect between the control group and the intervention group, with primary outcomes and secondary outcomes as the dependent variables.
This is the first study that investigates the effect of a combined lifestyle intervention and fitness training on physical activity. Temporary effects of the fitness training are expected to be maintained by changes to an active lifestyle in daily life and in the home situation.
Trial registration
This study is registered in the Dutch Trial Register as NTR2099.
PMCID: PMC2989952  PMID: 21044314
21.  Uric Acid Levels in Normotensive Children of Hypertensive Parents 
This study evaluated uric acid concentrations in normotensive children of parents with hypertension. Eighty normotensive children from families with and without a history of essential hypertension were included. Concentrations of lipid parameters and uric acid were compared. Demographic and anthropometric characteristics were similar in the groups. Systolic and diastolic blood pressure were higher in the normotensive children of parents with hypertension without statistically significant difference (P > 0.05). Uric acid concentrations were higher in the normotensive children of parents with hypertension (4.61 versus 3.57 mg/dL, P < 0.01). Total cholesterol and triglyceride concentrations were similar in the two groups. Systolic and diastolic blood pressure were significantly higher in control children aged >10 years (P < 0.01). Uric acid levels were significantly higher in all children with more pronounced difference after age 10 of years (P < 0.001). Positive correlations were found between the level of serum uric acid and age, body weight, body mass index, and systolic and diastolic blood pressure in the normotensive children of parents. The higher uric acid levels in the normotensive children of hypertensive parents suggest that uric acid may be a predeterminant of hypertension. Monitoring of uric acid levels in these children may allow for prevention or earlier treatment of future hypertension.
PMCID: PMC4590931  PMID: 26464873
22.  Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS) 
BMC Public Health  2014;14:313.
Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children.
The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm.
This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp settings for preventing overweight in children.
Trial registration
NCT01574352 at on the 8th of March 2012.
PMCID: PMC4234018  PMID: 24708676
RCT; Overweight; Children; Intervention; Physical activity; Weight loss; Camp intervention
23.  Left ventricular morphology and diastolic function in uraemia: echocardiographic evidence of a specific cardiomyopathy. 
British Heart Journal  1995;74(2):174-179.
OBJECTIVE--To see whether cardiac morphological and functional abnormalities in uraemic patients are determined by high blood pressure or if they are an expression of a specific cardiomyopathy. DESIGN--Cross sectional study. SETTING--City general hospital in Italy. SUBJECTS--35 uraemic patients receiving haemodialysis (17 men, 18 women; mean age 60.3 (11.2); mean duration of dialysis 52 months) were selected from the 64 patients in Venice who were receiving dialysis; subjects with diabetes, haemochromatosis, valvar dysfunction, regional dyskinesias, and pericarditis were excluded. 19 control normotensive subjects (6 men and 13 women), matched for age. MAIN OUTCOME MEASURES--Echocardiographic measurements of left atrium, left ventricular end diastolic and end systolic volume, aortic root diameter, posterior wall and interventricular septum thickness, left ventricle mass index, and ejection fraction in controls and in patients according to whether they were normotensive (five men, eight women) or hypertensive (12 men, 10 women) on 48 hour ambulatory monitoring; left ventricular diastolic function by Doppler ultrasonography. RESULTS--Mean systolic and diastolic pressures, daytime systolic and diastolic pressures, and night time systolic and diastolic pressures were significantly higher in the hypertensive patients than in the normotensive patients. The normotensive patients had similar blood pressures to the controls. Left ventricular mass correlated significantly with the mean diastolic pressure and mean night time systolic and diastolic pressures. Parathyroid hormone concentrations were similar in the two groups of patients. Diastolic relaxation was impaired to the same degree in the two groups of patients. Parameters of diastolic function showed no relation to left ventricular mass, which was significantly higher in the hypertensive than in the normotensive patients. CONCLUSIONS--Uraemia is likely to induce specific changes in the relaxation properties of the myocardium. These changes are responsible for the impaired diastolic function independently of blood pressure, degree of hypertrophy, and metabolic changes, which suggests the existence of a specific cardiomyopathy. Hypertension remains a determinant of left ventricular mass.
PMCID: PMC483995  PMID: 7546998
24.  Impact of a nurse-directed, coordinated school health program to enhance physical activity behaviors and reduce body mass index among minority children: A parallel-group, randomized control trial 
Underserved children, particularly girls and those in urban communities, do not meet the recommended physical activity guidelines (>60 min of daily physical activity), and this behavior can lead to obesity. The school years are known to be a critical period in the life course for shaping attitudes and behaviors. Children look to schools for much of their access to physical activity. Thus, through the provision of appropriate physical activity programs, schools have the power to influence apt physical activity choices, especially for underserved children where disparities in obesity-related outcomes exist.
To evaluate the impact of a nurse directed, coordinated, culturally sensitive, school-based, family-centered lifestyle program on activity behaviors and body mass index. Design, settings and participants: This was a parallel group, randomized controlled trial utilizing a community-based participatory research approach, through a partnership with a University and 5 community schools. Participants included 251 children ages 8–12 from elementary schools in urban, low-income neighborhoods in Los Angeles, USA.
The intervention included Kids N Fitness©, a 6-week program which met weekly to provide 45 min of structured physical activity and a 45 min nutrition education class for parents and children. Intervention sites also participated in school-wide wellness activities, including health and counseling services, staff professional development in health promotion, parental education newsletters, and wellness policies for the provision of healthy foods at the school. The Child and Adolescent Trial for Cardiovascular Health School Physical Activity and Nutrition Student Questionnaire measured physical activity behavior, including: daily physical activity, participation in team sports, attending physical education class, and TV viewing/computer game playing. Anthropometric measures included height, weight, body mass index, resting blood pressure, and waist circumference. Measures were collected at baseline, completion of the intervention phase (4 months), and 12 months post-intervention.
Significant results for students in the intervention, included for boys decreases in TV viewing; and girls increases in daily physical activity, physical education class attendance, and decreases in body mass index z-scores from baseline to the 12 month follow-up.
Our study shows the value of utilizing nurses to implement a culturally sensitive, coordinated, intervention to decrease disparities in activity and TV viewing among underserved girls and boys.
PMCID: PMC3654538  PMID: 23021318
Community based participatory research; Gender; Health disparities; Obesity in children; Physical activity; School-based interventions
25.  Bicycling to school improves the cardiometabolic risk factor profile: a randomised controlled trial 
BMJ Open  2012;2(6):e001307.
To investigate whether bicycling to school improves cardiometabolic risk factor profile and cardiorespiratory fitness among children.
Prospective, blinded, randomised controlled trial.
Single centre study in Odense, Denmark
43 children previously not bicycling to school were randomly allocated to control group (n=20) (ie, no change in lifestyle) or intervention group (ie, bicycling to school) (n=23).
Primary and secondary outcome measures
Change in cardiometabolic risk factor score and change in cardiorespiratory fitness.
All participants measured at baseline returned at follow-up. Based upon intention-to-treat (ITT) analyses, clustering of cardiometabolic risk factors was lowered by 0.58 SD (95% CI −1.03 to −0.14, p=0.012) in the bicycling group compared to the control group. Cardiorespiratory fitness (l O2/min) per se did not increase significantly more in the intervention than in the control group (β=0.0337, 95% CI −0.06 to 0.12, p=0.458).
Bicycling to school counteracted a clustering of cardiometabolic risk factors and should thus be recognised as potential prevention of type 2 diabetes mellitus and cardiovascular disease (CVD). The intervention did, however, not elicit a larger increase in cardiorespiratory fitness in the intervention group as compared with the control group.
Trial registration
Registered at (NCT01236222).
PMCID: PMC3533114  PMID: 23117560
cardiometabolic; risk factors; bicycling; children; commuting

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