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1.  A randomised controlled trial of three very brief interventions for physical activity in primary care 
BMC Public Health  2016;16:1033.
Background
Very brief interventions (VBIs) for physical activity are promising, but there is uncertainty about their potential effectiveness and cost. We assessed potential efficacy, feasibility, acceptability, and cost of three VBIs in primary care, in order to select the most promising intervention for evaluation in a subsequent large-scale RCT.
Methods
Three hundred and ninety four adults aged 40–74 years were randomised to a Motivational (n = 83), Pedometer (n = 74), or Combined (n = 80) intervention, delivered immediately after a preventative health check in primary care, or control (Health Check only; n = 157). Potential efficacy was measured as the probability of a positive difference between an intervention arm and the control arm in mean physical activity, measured by accelerometry at 4 weeks.
Results
For the primary outcome the estimated effect sizes (95 % CI) relative to the Control arm for the Motivational, Pedometer and Combined arms were respectively: +20.3 (−45.0, +85.7), +23.5 (−51.3, +98.3), and −3.1 (−69.3, +63.1) counts per minute. There was a73% probability of a positive effect on physical activity for each of the Motivational and Pedometer VBIs relative to control, but only 46 % for the Combined VBI. Only the Pedometer VBI was deliverable within 5 min. All VBIs were acceptable and low cost.
Conclusions
Based on the four criteria, the Pedometer VBI was selected for evaluation in a large-scale trial.
Trial registration
Current Controlled Trials ISRCTN02863077. Retrospectively registered 05/10/2012.
Electronic supplementary material
The online version of this article (doi:10.1186/s12889-016-3684-7) contains supplementary material, which is available to authorized users.
doi:10.1186/s12889-016-3684-7
PMCID: PMC5045643  PMID: 27716297
Very brief interventions; Physical activity; Behaviour change techniques; Health promotion; Public health; Primary care
2.  Does Electronic Monitoring Influence Adherence to Medication? Randomized Controlled Trial of Measurement Reactivity 
Annals of Behavioral Medicine  2014;48(3):293-299.
Background
Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence.
Purpose
To test the reactive effect of electronic monitoring in a randomized controlled trial.
Methods
A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5–25) and HbA1c at 8 weeks.
Results
Non-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI −0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), −1.02 [−2.73 to 0.71, p = 0.25]).
Conclusions
Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359)
doi:10.1007/s12160-014-9595-x
PMCID: PMC4223537  PMID: 24573909
Measurement reactivity; Medication adherence; Electronic monitoring; Diabetes
3.  Self-Rated Health and Cardiovascular Disease Incidence: Results from a Longitudinal Population-Based Cohort in Norfolk, UK 
PLoS ONE  2013;8(6):e65290.
Introduction
Self-rated health (SRH) predicts chronic disease morbidity including cardiovascular disease (CVD). In a population-based cohort, we examined the association between SRH and incident CVD and whether this association was independent of socio-demographic, clinical and behavioural participant characteristics.
Methods
Population-based prospective cohort study (European Prospective Investigation of Cancer-Norfolk). 20,941 men and women aged 39–74 years without prevalent CVD attended a baseline health examination (1993–1998) and were followed for CVD events/death until March 2007 (mean 11 years). We used a Cox proportional hazards model to quantify the association between baseline SRH (reported on a four point scale – excellent, good, fair, poor) and risk of developing CVD at follow-up after adjusting for socio-demographic, clinical and behavioural risk factors.
Results
Baseline SRH was reported as excellent by 17.8% participants, good by 65.1%, fair by 16.0% and poor by 1.2%. During 225,508 person-years of follow-up, there were 55 (21.2%) CVD events in the poor SRH group and 259 (7.0%) in the excellent SRH group (HR 3.7, 95% CI 2.8–4.9). The HR remained significant after adjustment for behavioural risk factors (HR 2.6, 95% CI 1.9–3.5) and after adjustment for all socio-demographic, clinical and behavioural risk factors (HR 3.3, 95% CI 2.4–4.4). Associations were strong for both fatal and non-fatal events and remained strong over time.
Conclusions
SRH is a strong predictor of incident fatal and non-fatal CVD events in this healthy, middle-aged population. Some of the association is explained by lifestyle behaviours, but SRH remains a strong predictor after adjustment for socio-demographic, clinical and behavioural risk factors and after a decade of follow-up. This easily accessible patient-centred measure of health status may be a useful indicator of individual and population health for those working in primary care and public health.
doi:10.1371/journal.pone.0065290
PMCID: PMC3670935  PMID: 23755212
4.  Relationship of Self-Rated Health to Stroke Incidence and Mortality in Older Individuals with and without a History of Stroke: A Longitudinal Study of the MRC Cognitive Function and Ageing (CFAS) Population 
PLoS ONE  2016;11(2):e0150178.
Introduction
Poor self-rated health (SRH) has been associated with increased risk of death and poor health outcomes even after adjusting for confounders. However its’ relationship with disease-specific mortality and morbidity has been less studied. SRH may also be particularly predictive of health outcomes in those with pre-existing conditions. We studied whether SRH predicts new stroke in older people who have never had a stroke, or a recurrence in those with a prior history of stroke.
Methods
MRC CFAS I is a multicentre cohort study of a population representative sample of people in their 65th year and older. A comprehensive interview at baseline included questions about presence of stroke, self-rated health and functional disability. Follow-up at 2 years included self-report of stroke and stroke death obtained from death certificates. Multiple logistical regression determined odds of stroke at 2 years adjusting for confounders including disability and health behaviours. Survival analysis was performed until June 2014 with follow-up for up to 13 years.
Results
11,957 participants were included, of whom 11,181 (93.8%) had no history of stroke and 776 (6.2%) one or more previous strokes. Fewer with no history of stroke reported poor SRH than those with stroke (5 versus 21%). In those with no history of stroke, poor self-rated health predicted stroke incidence (OR 1.5 (1.1–1.9)), but not stroke mortality (OR 1.2 (0.8–1.9)) at 2 years nor for up to 13 years (OR 1.2(0.9–1.7)). In those with a history of stroke, self-rated health did not predict stroke incidence (OR 0.9(0.6–1.4)), stroke mortality (OR 1.1(0.5–2.5)), or survival (OR 1.1(0.6–2.1)).
Conclusions
Poor self-rated health predicts risk of stroke at 2 years but not stroke mortality among the older population without a previous history of stroke. SRH may be helpful in predicting who may be at risk of developing a stroke in the near future.
doi:10.1371/journal.pone.0150178
PMCID: PMC4771829  PMID: 26928666
5.  Patient-centred care, health behaviours and cardiovascular risk factor levels in people with recently diagnosed type 2 diabetes: 5-year follow-up of the ADDITION-Plus trial cohort 
BMJ Open  2016;6(1):e008931.
Objective
To examine the association between the experience of patient-centred care (PCC), health behaviours and cardiovascular disease (CVD) risk factor levels among people with type 2 diabetes.
Design
Population-based prospective cohort study.
Setting
34 general practices in East Anglia, UK, delivering organised diabetes care.
Participants
478 patients recently diagnosed with type 2 diabetes aged between 40 and 69 years enrolled in the ADDITION-Plus trial.
Main outcome measures
Self-reported and objectively measured health behaviours (diet, physical activity, smoking status), CVD risk factor levels (blood pressure, lipid levels, glycated haemoglobin, body mass index, waist circumference) and modelled 10-year CVD risk.
Results
Better experiences of PCC early in the course of living with diabetes were not associated with meaningful differences in self-reported physical activity levels including total activity energy expenditure (β-coefficient: 0.080 MET h/day (95% CI 0.017 to 0.143; p=0.01)), moderate-to-vigorous physical activity (β-coefficient: 5.328 min/day (95% CI 0.796 to 9.859; p=0.01)) and reduced sedentary time (β-coefficient: −1.633 min/day (95% CI −2.897 to −0.368; p=0.01)). PCC was not associated with clinically meaningful differences in levels of high-density lipoprotein cholesterol (β-coefficient: 0.002 mmol/L (95% CI 0.001 to 0.004; p=0.03)), systolic blood pressure (β-coefficient: −0.561 mm Hg (95% CI −0.653 to −0.468; p=0.01)) or diastolic blood pressure (β-coefficient: −0.565 mm Hg (95% CI −0.654 to −0.476; p=0.01)). Over an extended follow-up of 5 years, we observed no clear evidence that PCC was associated with self-reported, clinical or biochemical outcomes, except for waist circumference (β-coefficient: 0.085 cm (95% CI 0.015 to 0.155; p=0.02)).
Conclusions
We found little evidence that experience of PCC early in the course of diabetes was associated with clinically important changes in health-related behaviours or CVD risk factors.
Trial registration number
ISRCTN99175498; Post-results.
doi:10.1136/bmjopen-2015-008931
PMCID: PMC4716169  PMID: 26739725
Type 2 diabetes; PRIMARY CARE; patient-centred care
7.  Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future disease risk 
BMJ : British Medical Journal  1998;317(7167):1202-1208.
Objective To assess the effect of additional training of practice nurses and general practitioners in patient centred care on the lifestyle and psychological and physiological status of patients with newly diagnosed type 2 diabetes.
Design Pragmatic parallel group design, with randomisation between practice teams to routine care (comparison group) or routine care plus additional training (intervention group); analysis at one year, allowing for practice effects and stratifiers; self reporting by patients on communication with practitioners, satisfaction with treatment, style of care, and lifestyle.
Setting 41 practices (21 in intervention group, 20 in comparison group) in a health region in southern England.
Subjects 250/360 patients (aged 30-70 years) diagnosed with type 2 diabetes and completing follow up at one year (142 in intervention group, 108 in comparison group).
Intervention 1.5 days’ group training for the doctors and nurses—introducing evidence for and skills of patient centred care and a patient held booklet encouraging questions.
Main outcome measures Quality of life, wellbeing, haemoglobin A1c and lipid concentrations, blood pressure, body mass index (kg/m2).
Results Compared with patients in the C group, those in the intervention group reported better communication with the doctors (odds ratio 2.8; 95% confidence interval 1.8 to 4.3) and greater treatment satisfaction (1.6; 1.1 to 2.5) and wellbeing (difference in means (d) 2.8; 0.4 to 5.2). However, their body mass index was significantly higher (d=2.0; 0.3 to 3.8), as were triglyceride concentrations (d=0.4 mmol/l; 0.07 to 0.73 mmol/l), whereas knowledge scores were lower (d=−2.74; −0.23 to −5.25). Differences in lifestyle and glycaemic control were not significant.
Conclusions The findings suggest greater attention to the consultation process than to preventive care among trained practitioners; those committed to achieving the benefits of patient centred consulting should not lose the focus on disease management.
Key messagesA training programme in patient centred care for practitioners led to patients with newly diagnosed diabetes reporting better communication with doctors, greater wellbeing, and greater treatment satisfaction at one year, without loss of glycaemic controlKnowledge scores were lower and weight and other cardiovascular risk factors higher among patients attending trained practice teamsTrained practitioners may have found it difficult to integrate attention to wellbeing with management of disease riskProfessionals using patient centred consulting should not lose the focus on disease
PMCID: PMC28704  PMID: 9794859
15.  Public attitudes towards pricing policies to change health-related behaviours: a UK focus group study 
Background: Evidence supports the use of pricing interventions in achieving healthier behaviour at population level. The public acceptability of this strategy continues to be debated throughout Europe, Australasia and USA. We examined public attitudes towards, and beliefs about the acceptability of pricing policies to change health-related behaviours in the UK. The study explores what underlies ideas of acceptability, and in particular those values and beliefs that potentially compete with the evidence presented by policy-makers. Methods: Twelve focus group discussions were held in the London area using a common protocol with visual and textual stimuli. Over 300 000 words of verbatim transcript were inductively coded and analyzed, and themes extracted using a constant comparative method. Results: Attitudes towards pricing policies to change three behaviours (smoking, and excessive consumption of alcohol and food) to improve health outcomes, were unfavourable and acceptability was low. Three sets of beliefs appeared to underpin these attitudes: (i) pricing makes no difference to behaviour; (ii) government raises prices to generate income, not to achieve healthier behaviour and (iii) government is not trustworthy. These beliefs were evident in discussions of all types of health-related behaviour. Conclusions: The low acceptability of pricing interventions to achieve healthier behaviours in populations was linked among these responders to a set of beliefs indicating low trust in government. Acceptability might be increased if evidence regarding effectiveness came from trusted sources seen as independent of government and was supported by public involvement and hypothecated taxation.
doi:10.1093/eurpub/ckv077
PMCID: PMC4668325  PMID: 25983329
16.  Association of self-rated health with multimorbidity, chronic disease and psychosocial factors in a large middle-aged and older cohort from general practice: a cross-sectional study 
BMC Family Practice  2014;15:185.
Background
The prevalence of coexisting chronic conditions (multimorbidity) is rising. Disease labels, however, give little information about impact on subjective health and personal illness experience. We aim to examine the strength of association of single and multimorbid physical chronic diseases with self-rated health in a middle-aged and older population in England, and to determine whether any association is mediated by depression and other psychosocial factors.
Methods
25 268 individuals aged 39 to 79 years recruited from general practice registers in the European Prospective Investigation of Cancer (EPIC-Norfolk) study, completed a survey including self-rated health, psychosocial function and presence of common physical chronic conditions (cancer, stroke, heart attack, diabetes, asthma/bronchitis and arthritis). Logistic regression models determined odds of “moderate/poor” compared to “good/excellent” health by condition and number of conditions adjusting for psychosocial measures.
Results
One-third (8252) reported one, around 7.5% (1899) two, and around 1% (194) three or more conditions. Odds of “moderate/poor” self-rated health worsened with increasing number of conditions (one (OR = 1.3(1.2–1.4)) versus three or more (OR = 3.4(2.3–5.1)), and were highest where there was comorbidity with stroke (OR = 8.7(4.6–16.7)) or heart attack (OR = 8.5(5.3–13.6)). Psychosocial measures did not explain the association between chronic diseases and multimorbidity with self-rated health.The relationship of multimorbidity with self-rated health was particularly strong in men compared to women (three or more conditions: men (OR = 5.2(3.0–8.9)), women OR = 2.1(1.1–3.9)).
Conclusions
Self-rated health provides a simple, integrative patient-centred assessment for evaluation of illness in the context of multiple chronic disease diagnoses. Those registering in general practice in particular men with three or more diseases or those with cardiovascular comorbidities and with poorer self-rated health may warrant further assessment and intervention to improve their physical and subjective health.
doi:10.1186/s12875-014-0185-6
PMCID: PMC4245775  PMID: 25421440
General practice/family medicine; General integrated subjective health multimorbidity comorbidity
17.  Relationship of Self-Rated Health with Fatal and Non-Fatal Outcomes in Cardiovascular Disease: A Systematic Review and Meta-Analysis 
PLoS ONE  2014;9(7):e103509.
Background
People who rate their health as poor experience higher all-cause mortality. Study of disease-specific association with self-rated health might increase understanding of why this association exists.
Objectives
To estimate the strength of association between self-rated health and fatal and non-fatal cardiovascular disease.
Methods
A comprehensive search of PubMed MEDLINE, EMBASE, CINAHL, BIOSIS, PsycINFO, DARE, Cochrane Library, and Web of Science was undertaken during June 2013. Two reviewers independently searched databases and selected studies. Inclusion criteria were prospective cohort studies or cohort analyses of randomised trials with baseline measurement of self-rated health with fatal or non-fatal cardiovascular outcomes. 20 studies were pooled quantitatively in different meta-analyses. Study quality was assessed using Newcastle-Ottawa scales.
Results
‘Poor’ relative to ‘excellent’ self-rated health (defined by most extreme categories in each study, most often’ poor’ or ‘very poor’ and ‘excellent’ or ‘good’) was associated over a follow-up of 2.3–23 years with cardiovascular mortality in studies: where varying degrees of adjustments had been made for cardiovascular disease risk (HR 1.79 (95% CI 1.50 to 2.14); 15 studies, I2 = 71.24%), and in studies reporting outcomes in people with pre-existing cardiovascular disease or ischaemic heart disease symptoms (HR 2.42 (95% CI 1.32 to 4.44); 3 studies; I2 = 71.83%). ‘Poor’ relative to ‘excellent’ self rated health was also associated with the combined outcome of fatal and non-fatal cardiovascular events (HR 1.90 (95% CI 1.26 to 2.87); 5 studies; I2 = 68.61%), Self-rated health was not significantly associated with non-fatal cardiovascular disease outcomes (HR 1.66 (95% CI 0.96 to 2.87); 5 studies; I2 = 83.60%).
Conclusions
Poor self rated health is associated with cardiovascular mortality in populations with and without prior cardiovascular disease. Those with current poor self-rated health may warrant additional input from health services to identify and address reasons for their low subjective health.
doi:10.1371/journal.pone.0103509
PMCID: PMC4116199  PMID: 25076041
18.  Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial 
Journal of Obesity  2014;2014:646504.
Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.
doi:10.1155/2014/646504
PMCID: PMC4131118  PMID: 25143830
19.  Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study) 
Background
Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked.
Methods
211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded.
Results
Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients’ action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group.
Conclusions
It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects.
Trial registration
ISRCTN30522359.
doi:10.1186/1748-5908-9-70
PMCID: PMC4055947  PMID: 24902481
Fidelity; Implementation; Medication adherence; Behaviour change techniques; Process evaluation
20.  Which Behavior Change Techniques are Associated with Changes in Physical Activity, Diet and Body Mass Index in People with Recently Diagnosed Diabetes? 
Annals of Behavioral Medicine  2014;49(1):7-17.
Background
Meta-analyses have identified promising behavior change techniques (BCTs) in changing obesity-related behaviors from intervention descriptions. However, it is unclear whether these BCTs are used by intervention participants and are related to outcomes.
Purpose
The purpose of this study is to investigate BCT use by participants of an intervention targeting physical activity and diet and whether BCT use was related to behavior change and weight loss.
Methods
Intervention participants (N = 239; 40–69 years) with recently diagnosed type 2 diabetes in the ADDITION-Plus trial received a theory-based intervention which taught them a range of BCTs. BCT usage was reported at 1 year.
Results
Thirty-six percent of the participants reported using all 16 intervention BCTs. Use of a higher number of BCTs and specific BCTs (e.g., goal setting) were associated with a reduction in body mass index (BMI).
Conclusions
BCT use was associated with weight loss. Future research should identify strategies to promote BCT use in daily life. (Trial Registration: ISRCTN99175498.)
Electronic supplementary material
The online version of this article (doi:10.1007/s12160-014-9624-9) contains supplementary material, which is available to authorized users.
doi:10.1007/s12160-014-9624-9
PMCID: PMC4335098  PMID: 24806469
Behavior change techniques; Diet; Physical activity; Weight loss; Theory-based intervention; Intervention fidelity; Diabetes
21.  Using the 7-point checklist as a diagnostic aid for pigmented skin lesions in general practice: a diagnostic validation study 
The British Journal of General Practice  2013;63(610):e345-e353.
Background
GPs need to recognise significant pigmented skin lesions, given rising UK incidence rates for malignant melanoma. The 7-point checklist (7PCL) has been recommended by NICE (2005) for routine use in UK general practice to identify clinically significant lesions which require urgent referral.
Aim
To validate the Original and Weighted versions of the 7PCL in the primary care setting.
Design and setting
Diagnostic validation study, using data from a SIAscopic diagnostic aid randomised controlled trial in eastern England.
Method
Adults presenting in general practice with a pigmented skin lesion that could not be immediately diagnosed as benign were recruited into the trial. Reference standard diagnoses were histology or dermatology expert opinion; 7PCL scores were calculated blinded to the reference diagnosis. A case was defined as a clinically significant lesion for primary care referral to secondary care (total 1436 lesions: 225 cases, 1211 controls); or melanoma (36).
Results
For diagnosing clinically significant lesions there was a difference between the performance of the Original and Weighted 7PCLs (respectively, area under curve: 0.66, 0.69, difference = 0.03, P<0.001). For the identification of melanoma, similar differences were found. Increasing the Weighted 7PCL’s cut-off score from recommended 3 to 4 improved detection of clinically significant lesions in primary care: sensitivity 73.3%, specificity 57.1%, positive predictive value 24.1%, negative predictive value 92.0%, while maintaining high sensitivity of 91.7% and moderate specificity of 53.4% for melanoma.
Conclusion
The Original and Weighted 7PCLs both performed well in a primary care setting to identify clinically significant lesions as well as melanoma. The Weighted 7PCL, with a revised cut-off score of 4 from 3, performs slightly better and could be applied in general practice to support the recognition of clinically significant lesions and therefore the early identification of melanoma.
doi:10.3399/bjgp13X667213
PMCID: PMC3635581  PMID: 23643233
diagnostic techniques and procedures; general practice; melanoma; pigmented skin lesions
22.  Multiple behaviour change intervention and outcomes in recently diagnosed type 2 diabetes: the ADDITION-Plus randomised controlled trial 
Diabetologia  2014;57(7):1308-1319.
Aims/hypothesis
The aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes.
Methods
An explanatory randomised controlled trial was conducted in 34 general practices in Eastern England (Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ADDITION-Plus]). In all, 478 patients meeting eligibility criteria (age 40 to 69 years with recently diagnosed screen or clinically detected diabetes) were individually randomised to receive either intensive treatment (n = 239) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team (n = 239). Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms. Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours, including goal setting, self-monitoring and building habits. Primary outcomes included physical activity energy expenditure (individually calibrated heart rate monitoring and movement sensing), change in objectively measured fruit and vegetable intake (plasma vitamin C), medication adherence (plasma drug levels) and smoking status (plasma cotinine levels) at 1 year. Measurements, data entry and laboratory analysis were conducted with staff unaware of participants’ study group allocation.
Results
Of 475 participants still alive, 444 (93%; intervention group 95%, comparison group 92%) attended 1-year follow-up. There were no significant differences between groups in physical activity (difference: +1.50 kJ kg−1 day−1; 95% CI −1.74, 4.74), plasma vitamin C (difference: −3.84 μmol/l; 95% CI −8.07, 0.38), smoking (OR 1.37; 95% CI 0.77, 2.43) and plasma drug levels (difference in metformin levels: −119.5 μmol/l; 95% CI −335.0, 95.9). Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups.
Conclusions/interpretation
For patients with recently diagnosed type 2 diabetes receiving intensive treatment in UK primary care, a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over 1 year.
Trial registration
ISRCTN99175498
Funding
The trial is supported by the Medical Research Council, the Wellcome Trust, National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme. The Primary Care Unit is supported by NIHR Research funds. Bio-Rad provided equipment for HbA1c testing during the screening phase.
Electronic supplementary material
The online version of this article (doi:10.1007/s00125-014-3236-6) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
doi:10.1007/s00125-014-3236-6
PMCID: PMC4052009  PMID: 24759957
ADDITION-Plus; Diabetes; General practice; Health behaviour; Randomised trial
23.  Predictors of change in objectively measured and self-reported health behaviours among individuals with recently diagnosed type 2 diabetes: longitudinal results from the ADDITION-Plus trial cohort 
Background
There is limited evidence about predictors of health behaviour change in people with type 2 diabetes. The aim of this study was to assess change in health behaviours over one year and to identify predictors of behaviour change among adults with screen-detected and recently clinically diagnosed diabetes.
Methods
ADDITION-Plus was a randomised controlled trial of a behaviour change intervention among 478 patients (40–69 years). Physical activity and diet were measured objectively (physical activity at 1 year) and by self-report at baseline and one year. Associations between baseline predictors and behaviour change were quantified using multivariable linear regression.
Results
Participants increased their plasma vitamin C and fruit intake, reduced energy and fat intake from baseline to follow-up. Younger age, male sex, a smaller waist circumference, and a lower systolic blood pressure at baseline were associated with higher levels of objectively measured physical activity at one year. Greater increases in plasma vitamin C were observed in women (beta-coefficient [95% CI]: beta = −5.52 [−9.81, -1.22]) and in those with screen-detected diabetes (beta = 6.09 [1.74, 10.43]). Younger age predicted a greater reduction in fat (beta = −0.43 [−0.72, -0.13]) and energy intake (beta = −6.62 [−13.2, -0.05]). Patients with screen-detected diabetes (beta = 74.2 [27.92, 120.41]) reported a greater increase in fruit intake. There were no significant predictors of change in self-reported physical activity. Beliefs about behaviour change and diabetes did not predict behaviour change.
Conclusions
Older patients, men and those with a longer duration of diabetes may need more intensive support for dietary change. We recommend that future studies use objective measurement of health behaviours and that researchers add predictors beyond the individual level. Our results support a focus on establishing healthy lifestyle changes early in the diabetes disease trajectory.
doi:10.1186/1479-5868-10-118
PMCID: PMC3874745  PMID: 24152757
Health behaviour; Behaviour change; Predictors; Type 2 diabetes; Newly diagnosed
24.  Trials to Improve Blood Pressure Through Adherence to Antihypertensives in Stroke/TIA: Systematic Review and Meta‐Analysis 
Background
The purpose of this study was to determine whether interventions including components to improve adherence to antihypertensive medications in patients after stroke/transient ischemic attack (TIA) improve adherence and blood pressure control.
Methods and Results
We searched MEDLINE, EMBASE, CINAHL, BNI, PsycINFO, and article reference lists to October 2012. Search terms included stroke/TIA, adherence/prevention, hypertension, and randomized controlled trial (RCT). Inclusion criteria were participants with stroke/TIA; interventions including a component to improve adherence to antihypertensive medications; and outcomes including blood pressure, antihypertensive adherence, or both. Two reviewers independently assessed studies to determine eligibility, validity, and quality. Seven RCTs were eligible (n=1591). Methodological quality varied. All trials tested multifactorial interventions. None targeted medication adherence alone. Six trials measured blood pressure and 3 adherence. Meta‐analysis of 6 trials showed that multifactorial programs were associated with improved blood pressure control. The difference between intervention versus control in mean improvement in systolic blood pressure was −5.3 mm Hg (95% CI, −10.2 to −0.4 mm Hg, P=0.035; I2=67% [21% to 86%]) and in diastolic blood pressure was −2.5 mm Hg (−5.0 to −0.1 mm Hg, P=0.046; I2=47% [0% to 79%]). There was no effect on medication adherence where measured.
Conclusions
Multifactorial interventions including a component to improve medication adherence can lower blood pressure after stroke/TIA. However, it is not possible to say whether or not this is achieved through better medication adherence. Trials are needed of well‐characterized interventions to improve medication adherence and clinical outcomes with measurement along the hypothesized causal pathway.
doi:10.1161/JAHA.113.000251
PMCID: PMC3828799  PMID: 23963756
blood pressure; hypertension; prevention; stroke
25.  Cardiovascular risk reduction following diagnosis of diabetes by screening: 1-year results from the ADDITION-Cambridge trial cohort 
The British Journal of General Practice  2012;62(599):e396-e402.
Background
Uncertainties persist concerning the effects of early intensive management of type 2 diabetes and which patients benefit most from such an approach.
Aim
To describe change in modelled cardiovascular risk in the 14 months following diagnosis, and to examine which baseline patient characteristics and treatment components are associated with risk reduction.
Design and setting
A cohort of individuals from a pragmatic, single-blind, cluster-randomised controlled trial of 236 females and 361 males with screen-detected type 2 diabetes and without prior cardiovascular disease (CVD), from 49 GP surgeries in eastern England, examined at baseline (2002–2006) and after 14-months’ follow-up.
Method
Multiple linear regression was used to quantify the association between baseline patient characteristics, treatment components, and change in modelled 10-year cardiovascular risk (UK Prospective Diabetes Study [UKPDS] [version 3] risk engine).
Results
There was a downward shift in the distribution of modelled CVD risk over 14 months mean 31% (standard deviation [SD] = 14%) to 26% [SD = 13%]). Older individuals, males, and those with a larger waist circumference at baseline exhibited smaller risk reductions. Individuals prescribed higher numbers of drugs over the follow-up period, and those who decreased their energy intake or reduced their weight, demonstrated larger reductions in modelled risk.
Conclusion
It is possible to achieve significant reductions in modelled CVD risk over 14 months following diagnosis of diabetes by screening. Risk reduction appeared to be driven mainly by prescription of higher numbers of drugs, decreased energy intake, and weight reduction. There was room for further risk reduction, as many patients were not prescribed recommended treatments.
doi:10.3399/bjgp12X649070
PMCID: PMC3361118  PMID: 22687231
cardiovascular diseases, prevention and control; diabetes mellitus; equity; mass screening; primary care; risk factors; socioeconomic factors

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