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1.  Lifestyle Counseling for Type 2 Diabetes Risk Reduction in Dutch Primary Care 
Diabetes Care  2011;34(9):1919-1925.
OBJECTIVE
To study the overall effect of the Active Prevention in High-Risk Individuals of Diabetes Type 2 in and Around Eindhoven (APHRODITE) lifestyle intervention on type 2 diabetes risk reduction in Dutch primary care after 0.5 and 1.5 years and to evaluate the variability between general practices.
RESEARCH DESIGN AND METHODS
Individuals at high risk for type 2 diabetes (Finnish Diabetes Risk Score ≥13) were randomly assigned into an intervention group (n = 479) or a usual-care group (n = 446). Comparisons were made between study groups and between general practices regarding changes in clinical and lifestyle measures over 1.5 years. Participant, general practitioner, and nurse practitioner characteristics were compared between individuals who lost weight or maintained a stable weight and individuals who gained weight.
RESULTS
Both groups showed modest changes in glucose values, weight measures, physical activity, energy intake, and fiber intake. Differences between groups were significant only for total physical activity, saturated fat intake, and fiber intake. Differences between general practices were significant for BMI and 2-h glucose but not for energy intake and physical activity. In the intervention group, the nurse practitioners’ mean years of work experience was significantly longer in individuals who were successful at losing weight or maintaining a stable weight compared with unsuccessful individuals. Furthermore, successful individuals more often had a partner.
CONCLUSIONS
Risk factors for type 2 diabetes could be significantly reduced by lifestyle counseling in Dutch primary care. The small differences in changes over time between the two study groups suggest that additional intervention effects are modest. In particular, the level of experience of the nurse practitioner and the availability of partner support seem to facilitate intervention success.
doi:10.2337/dc10-2293
PMCID: PMC3161269  PMID: 21775759
2.  Behavior change in a lifestyle intervention for type 2 diabetes prevention in Dutch primary care: opportunities for intervention content 
BMC Family Practice  2013;14:78.
Background
Despite the favorable effects of behavior change interventions on diabetes risk, lifestyle modification is a complicated process. In this study we therefore investigated opportunities for refining a lifestyle intervention for type 2 diabetes prevention, based on participant perceptions of behavior change progress.
Methods
A 30 month intervention was performed in Dutch primary care among high-risk individuals (FINDRISC-score ≥ 13) and was compared to usual care. Participant perceptions of behavior change progress for losing weight, dietary modification, and increasing physical activity were assessed after18 months with questionnaires. Based on the response, participants were categorized as ‘planners’, ‘initiators’ or ‘achievers’ and frequencies were evaluated in both study groups. Furthermore, participants reported on barriers for lifestyle change.
Results
In both groups, around 80% of all participants (intervention: N = 370; usual care: N = 322) planned change. Except for reducing fat intake (p = 0.08), the number of initiators was significantly higher in the intervention group than in usual care. The percentage of achievers was high for the dietary and exercise objectives (intervention: 81–95%; usual care: 83–93%), but was lower for losing weight (intervention: 67%; usual care: 62%). Important motivational barriers were ‘I already meet the standards’ and ‘I’m satisfied with my current behavior’. Temptation to snack, product taste and lack of time were important volitional barriers.
Conclusions
The results suggest that the intervention supports participants to bridge the gap between motivation and action. Several opportunities for intervention refinement are however revealed, including more stringent criteria for participant inclusion, tools for (self)-monitoring of health, emphasis on the ‘small-step-approach’, and more attention for stimulus control.
Trial registration
Netherlands Trial Register: NTR1082
doi:10.1186/1471-2296-14-78
PMCID: PMC3706294  PMID: 23758998
Type 2 diabetes; Primary care; Behavior change; Lifestyle intervention
3.  Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial 
BMC Family Practice  2012;13:109.
Background
The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza.
Methods/design
This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation.
Discussion
The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice.
Trial registration
ClinicalTrials.gov NCT01365013
doi:10.1186/1471-2296-13-109
PMCID: PMC3538670  PMID: 23158830
Pre-diabetes; Primary health care; Prevention; Clinical trial
4.  Effects of lifestyle intervention in persons at risk for type 2 diabetes mellitus - results from a randomised, controlled trial 
BMC Public Health  2011;11:893.
Background
Lifestyle change is probably the most important single action to prevent type 2 diabetes mellitus. The purpose of this study was to assess the effects of a low-intensity individual lifestyle intervention by a physician and compare this to the same physician intervention combined with an interdisciplinary, group-based approach in a real-life setting.
Methods
The "Finnish Diabetes Risk score" (FINDRISC) was used by GPs to identify individuals at high risk. A randomised, controlled design and an 18 month follow-up was used to assess the effect of individual lifestyle counselling by a physician (individual physician group, (IG)) every six months, with emphasis on diet and exercise, and compare this to the same individual lifestyle counselling combined with a group-based interdisciplinary program (individual and interdisciplinary group, (IIG)) provided over 16 weeks. Primary outcomes were changes in lifestyle indicated by weight reduction ≥ 5%, improvement in exercise capacity as assessed by VO2 max and diet improvements according to the Smart Diet Score (SDS).
Results
213 participants (104 in the IG and 109 in the IIG group, 50% women), with a mean age of 46 and mean body mass index 37, were included (inclusion rate > 91%) of whom 182 returned at follow-up (drop-out rate 15%). There were no significant differences in changes in lifestyle behaviours between the two groups. At baseline 57% (IG) and 53% (IIG) of participants had poor aerobic capacity and after intervention 35% and 33%, respectively, improved their aerobic capacity at least one metabolic equivalent. Unhealthy diets according to SDS were common in both groups at baseline, 61% (IG) and 60% (IIG), but uncommon at follow-up, 17% and 10%, respectively. At least 5% weight loss was achieved by 35% (IG) and 28% (IIG). In the combined IG and IIG group, at least one primary outcome was achieved by 93% while all primary outcomes were achieved by 6%. Most successful was the 78% reduction in the proportion of participants with unhealthy diet (almost 50% absolute reduction).
Conclusion
It is possible to achieve important lifestyle changes in persons at risk for type 2 diabetes with modest clinical efforts. Group intervention yields no additional effects. The design of the study, with high inclusion and low dropout rates, should make the results applicable to ordinary clinical settings.
Trial registration
ClinicalTrials.gov: NCT00202748
doi:10.1186/1471-2458-11-893
PMCID: PMC3247299  PMID: 22117618
type 2 diabetes mellitus; prevention; lifestyle; obesity
5.  Effect of lifestyle intervention for people with diabetes or prediabetes in real-world primary care: propensity score analysis 
BMC Family Practice  2011;12:95.
Background
Many lifestyle interventions for patients with prediabetes or type 2 diabetes mellitus (T2DM) have been investigated in randomised clinical trial settings. However, the translation of these programmes into primary care seems challenging and the prevalence of T2DM is increasing. Therefore, there is an urgent need for lifestyle programmes, developed and shown to be effective in real-world primary care. We evaluated a lifestyle programme, commissioned by the Dutch government, for patients with prediabetes or type 2 diabetes in primary care.
Methods
We performed a retrospective comparative medical records analysis using propensity score matching. Patients with prediabetes or T2DM were selected from ten primary healthcare centres. Patients who received the lifestyle intervention (n = 186) were compared with a matched group of patients who received usual care (n = 2632). Data were extracted from the electronic primary care records. Propensity score matching was used to control for confounding by indication. Outcome measures were exercise level, BMI, HbA1c, fasting glucose, systolic and diastolic blood pressure, total cholesterol, HDL and LDL cholesterol and triglycerides and the follow-up period was one year.
Results
There was no significant difference at follow-up in any outcome measure between either group. The reduction at one year follow-up of HbA1c and fasting glucose was positive in the intervention group compared with controls, although not statistically significant (-0.12%, P = 0.07 and -0.17 mmol/l, P = 0.08 respectively).
Conclusions
The effects of the lifestyle programme in real-world primary care for patients with prediabetes or T2DM were small and not statistically significant. The attention of governments for lifestyle interventions is important, but from the available literature and the results of this study, it must be concluded that improving lifestyle in real-world primary care is still challenging.
doi:10.1186/1471-2296-12-95
PMCID: PMC3180644  PMID: 21914190
6.  Development and implementation of a lifestyle intervention to promote physical activity and healthy diet in the Dutch general practice setting: the BeweegKuur programme 
Background
The number of patients with diabetes is increasing. BeweegKuur (Dutch for 'Exercise Therapy') is a Dutch lifestyle intervention which aims to effectively and feasibly promote physical activity and better dietary behaviour in primary health care to prevent diabetes.
Methods
The goal of this paper is to present the development process and the contents of the intervention, using a model of systematic health promotion planning. The intervention consists of a 1-year programme for diabetic and prediabetic patients. Patients are referred by their general practitioner (GP) to a lifestyle advisor (LSA), usually the practice nurse or a physiotherapist. Based on specific inclusion criteria and in close collaboration with the patient, an individual exercise programme is designed and supervised by the LSA. This programme can be attended at existing local exercise facilities or (temporarily) under the supervision of a specialized exercise coach or physiotherapist. All participants are also referred to a dietician and receive diet-related group education. In the first pilot year (2008), the BeweegKuur programme was implemented in 7 regions in the Netherlands (19 GP practices and health centres), while 14 regions (41 GP practices and health centres) participated during the second year. The aim is to implement BeweegKuur in all regions of the Netherlands by 2012.
Discussion
The BeweegKuur programme was systematically developed in an evidence- and practice-based process. Formative monitoring studies and (controlled) effectiveness studies are needed to examine the diffusion process and the effectiveness and cost-effectiveness of the intervention.
doi:10.1186/1479-5868-7-49
PMCID: PMC3224934  PMID: 20504352
7.  Rationale and design of the PREDICE project: cost-effectiveness of type 2 diabetes prevention among high-risk Spanish individuals following lifestyle intervention in real-life primary care setting 
BMC Public Health  2011;11:623.
Background
Type 2 diabetes is an important preventable disease and a growing public health problem. Based on information provided by clinical trials, we know that Type 2 diabetes can be prevented or delayed by lifestyle intervention. In view of translating the findings of diabetes prevention research into real-life it is necessary to carry out community-based evaluations so as to learn about the feasibility and effectiveness of locally designed and implemented programmes. The aim of this project was to assess the effectiveness of an active real-life primary care strategy in high-risk individuals for developing diabetes, and then evaluate its efficiency.
Methods/Design
Cost-Effectiveness analysis of the DE-PLAN (Diabetes in Europe - Prevention using Lifestyle, physical Activity and Nutritional intervention) project when applied to a Mediterranean population in Catalonia (DE-PLAN-CAT). Multicenter, longitudinal cohort assessment (4 years) conducted in 18 primary health-care centres (Catalan Health Institute). Individuals without diabetes aged 45-75 years were screened using the Finnish Diabetes Risk Score - FINDRISC - questionnaire and a 2-h oral glucose tolerance test. All high risk tested individuals were invited to participate in either a usual care intervention (information on diet and cardiovascular health without individualized programme), or the intensive DE-PLAN educational program (individualized or group) periodically reinforced. Oral glucose tolerance test was repeated yearly to determine diabetes incidence. Besides measuring the accumulated incidence of diabetes, information was collected on economic impact of the interventions in both cohorts (using direct and indirect cost questionnaires) and information on utility measures (Quality Adjusted Life Years). A cost-utility and a cost-effectiveness analysis will be performed and data will be modelled to predict long-term cost-effectiveness.
Discussion
The project was intended to evidence that a substantial reduction in Type 2 diabetes incidence can be obtained at a reasonable cost-effectiveness ratio in real-life primary health care setting by an intensive lifestyle intervention. As far as we know, the DE-PLAN-CAT/PREDICE project represents the first assessment of long-term effectiveness and cost-effectiveness of a public healthcare strategy to prevent diabetes within a European primary care setting.
doi:10.1186/1471-2458-11-623
PMCID: PMC3199598  PMID: 21831332
8.  Economic Evaluation of Lifestyle Interventions for Preventing Diabetes and Cardiovascular Diseases 
Lifestyle interventions (i.e., diet and/or physical activity) are effective in delaying or preventing the onset of diabetes and cardiovascular disease. However, policymakers must know the cost-effectiveness of such interventions before implementing them at the large-scale population level. This review discusses various issues (e.g., characteristics, modeling, and long-term effectiveness) in the economic evaluation of lifestyle interventions for the primary and secondary prevention of diabetes and cardiovascular disease. The diverse nature of lifestyle interventions, i.e., type of intervention, means of provision, target groups, setting, and methodology, are the main obstacles to comparing evaluation results. However, most lifestyle interventions are among the intervention options usually regarded as cost-effective. Diabetes prevention programs, such as interventions starting with targeted or universal screening, childhood obesity prevention, and community-based interventions, have reported favorable cost-effectiveness ratios.
doi:10.3390/ijerph7083150
PMCID: PMC2954575  PMID: 20948954
lifestyle interventions; economic evaluation; Markov model; long-term effectiveness; primary prevention; secondary prevention; diabetes; cardiovascular disease; cost-effectiveness
9.  Feasibility, acceptability and outcomes at a 12-month follow-up of a novel community-based intervention to prevent type 2 diabetes in adults at high risk: mixed methods pilot study 
BMJ Open  2013;3(11):e003585.
Objectives and design
Lifestyle interventions can prevent type 2 diabetes (T2D) in adults with impaired glucose tolerance. In a mixed methods pilot study, we aimed to assess the feasibility, acceptability and outcomes at a 12-month follow-up of a behavioural intervention for adults at risk of T2D.
Participants
Adults aged 45–65 years with a Finnish Diabetes Risk Score (FINDRISC) ≥11.
Setting
The intervention was delivered in leisure and community settings in a local authority that ranks in the 10 most socioeconomically deprived in England.
Intervention
A 10-week supported programme to promote increased physical activity (PA), healthy eating and weight loss was delivered by fitness trainers as twice-weekly group PA or cookery sessions, each followed by behavioural counselling with support to 12 months.
Outcome measures
We assessed feasibility and acceptability of the intervention, and change in behavioural and health-related outcomes at 6 and 12 months.
Results
From 367 registers of interest, 218 participants were recruited to the programme with baseline mean (SD): age 53.6 (6) years, FINDRISC 13.9 (3.1), body mass index 33.5 (5.9) kg/m2, waist circumference 108.1 (13.7) cm, PA levels (self-report): daily total 49.1 (5.9) metabolic-equivalent (MET) h/day. Follow-up at 12 months was completed by 134 (61%) participants, with an estimated mean (95% CI) change from baseline in weight −5.7 (−7.8 to −2.8); −2.8 (−3.8 to −1.9) kg, waist circumference −7.2 (−9.2 to −5.2); −6.0 (−7.1 to −5.0) cm, and PA level 7.9 (5.8 to 10.1); 6.7 (5.2 to 8.2) MET h/day equivalent, for men and women, respectively (from covariance pattern mixed models). Participants reported an enjoyable, sociable and supportive intervention experience.
Conclusions
Participants’ views indicated a high level of intervention acceptability. High retention and positive outcomes at 12 months provide encouraging indications of the feasibility and potential effectiveness of the intervention. A definitive trial of this intervention is warranted.
doi:10.1136/bmjopen-2013-003585
PMCID: PMC3831101  PMID: 24227871
Diabetes & Endocrinology; Public Health; Preventive Medicine
10.  Lifestyle intervention for type 2 diabetes patients – trial protocol of The Copenhagen Type 2 Diabetes Rehabilitation Project 
BMC Public Health  2009;9:166.
Background
Current guidelines recommend education, physical activity and changes in diet for type 2 diabetes patients, yet the composition and organization of non-pharmacological care are still controversial. Therefore, it is very important that programmes aiming to improve non-pharmacological treatment of type 2 diabetes are developed and evaluated. The Copenhagen Type 2 Diabetes Rehabilitation Project aims to evaluate the effectiveness of a new group-based lifestyle rehabilitation programme in a Health Care Centre in primary care.
Methods/Design
The group-based diabetes rehabilitation programme consists of empowerment-based education, supervised exercise and dietary intervention. The effectiveness of this multi-disciplinary intervention is compared with conventional individual counselling in a Diabetes Outpatient Clinic and evaluated in a prospective and randomized controlled trial. During the recruitment period of 18 months 180 type 2 diabetes patients will be randomized to the intervention group and the control group. Effects on glycaemic control, quality of life, self-rated diabetes symptoms, body composition, blood pressure, lipids, insulin resistance, beta-cell function and physical fitness will be examined after 6, 12 and 24 months.
Discussion
The Copenhagen Type 2 Diabetes Rehabilitation Project evaluates a multi-disciplinary non-pharmacological intervention programme in a primary care setting and provides important information about how to organize non-pharmacological care for type 2 diabetes patients.
Trail Registration
ClinicalTrials.gov registration number: NCT00284609.
doi:10.1186/1471-2458-9-166
PMCID: PMC2694179  PMID: 19480671
11.  Increase in physical activity and cardiometabolic risk profile change during lifestyle intervention in primary healthcare: 1-year follow-up study among individuals at high risk for type 2 diabetes 
BMJ Open  2011;1(2):e000292.
Objectives
To investigate the association between increase in physical activity and changes in cardiometabolic risk factors during a lifestyle intervention programme in routine clinical settings.
Design
Prospective follow-up.
Setting
400 primary healthcare centres and occupational healthcare outpatient clinics in Finland.
Participants
Individuals at high risk for type 2 diabetes identified in the implementation project of the national diabetes prevention programme (FIN-D2D) and participating in baseline and 1-year follow-up visits. Final study group comprised the 1871 non-diabetic participants who responded at follow-up visit to a question on stability versus increase of physical activity.
Interventions
Lifestyle intervention.
Primary outcome measures
Cardiometabolic risk factors (body composition, blood pressure and those measured from fasting venous blood samples) measured at baseline and follow-up visits.
Results
Of the participants, 310 (16.6% of all responders) reported at follow-up having clearly increased their physical activity during the past year, while 1380 (73.8%) had been unable to increase their physical activity. Those who increased their activity decreased their weight by 3.6 kg (95% CI 2.9 to 4.3, age and sex adjusted, p<0.001) and waist circumference by 3.6 cm (95% CI 2.9 to 4.3, p<0.001) more than those who did not increase their activity. Similarly, those who increased their physical activity had greater reductions in total cholesterol (group difference in reduction 0.17 mmol/l, 95% CI 0.06 to 0.28, p=0.002), low-density lipoprotein cholesterol (0.16 mmol/l, 95% CI 0.06 to 0.26, p=0.001), low-density lipoprotein/high-density lipoprotein ratio (0.17, 95% CI 0.08 to 0.25, p<0.001) as well as fasting glucose (0.09 mmol/l, 95% CI 0.03 to 0.15, p=0.004) and 2 h glucose levels (0.36 mmol/l, 95% CI 0.17 to 0.55, p=0.023) than those who did not increase their physical activity.
Conclusion
Increasing physical activity seems to be an important feature of cardiometabolic risk reduction among individuals at high risk for type 2 diabetes participating in preventive interventions in routine clinical settings.
Article summary
Article focus
There is evidence from randomised controlled trials that supervised exercise interventions improve cardiometabolic risk factor levels.
It is not known how knowledge from intensive interventions of randomised clinical trials can be applied in various real-life clinical settings with limited resources.
In this paper, we report the results of an analysis of physical activity changes and their association to cardiometabolic risk factors among individual at high risk for type 2 diabetes and participating in preventive lifestyle intervention in routine clinical settings of primary healthcare.
Key messages
Less than one-fifth of the participants reported at ‘1-year’ follow-up having clearly increased their physical activity during the past year.
Those who increased their activity improved clearly their cardiometabolic risk profile including reductions of waist circumference and fasting low-density lipoprotein cholesterol and glucose levels, which result persisted after the adjustment for dietary change.
Increasing physical activity seems to be an important feature of cardiometabolic risk reduction among individuals at high risk for type 2 diabetes participating in preventive interventions in routine clinical settings.
Strengths and limitations
FIN-D2D is the first national effort to implement the prevention of diabetes in a primary healthcare setting.
Follow-up data on the changes in physical activity are available from a subgroup of participants.
The limitations of this report include that physical activity changes are documented by a questionnaire.
doi:10.1136/bmjopen-2011-000292
PMCID: PMC3244658  PMID: 22184585
12.  Economic evaluation of a lifestyle intervention in primary care to prevent type 2 diabetes mellitus and cardiovascular diseases: a randomized controlled trial 
BMC Family Practice  2013;14:45.
Background
Cost-effectiveness studies of lifestyle interventions in people at risk for lifestyle-related diseases, addressing ‘real-world’ implementation, are needed. This study examines the cost-effectiveness of a primary care intervention from a societal perspective, compared with provision of health brochures, alongside a randomized controlled trial.
Methods
Adults aged 30-50 years, at risk of type 2 diabetes (T2DM) and/or cardiovascular disease (CVD), were recruited from twelve general practices in The Netherlands. They were randomized to the intervention (n = 314) or control group (n = 308). The intervention consisted of up to six face-to-face counseling sessions with a trained practice nurse, followed by three-monthly sessions by phone. Costs were collected using three-monthly retrospective questionnaires. Quality of life was measured with the EuroQol-5D-3L, at baseline, 6, 12 and 24 months. Nine-year risk of developing T2DM and ten-year risk of CVD mortality were estimated using the ARIC and SCORE formulae, respectively, based on measurements at baseline and 24 months while applying a fixed age of 60 years at both time points.
Results
Small, statistically non-significant differences in effects were found between the intervention and control group with regard to risk scores and Quality Adjusted Life Years (QALYs) gained. The mean difference in costs between the intervention and control group was €-866 (95% confidence interval -2372; 370). The probability that the intervention was cost-effective varied from 93% at €8000/QALY to 88% at €80,000/QALY.
Conclusion
A primary care lifestyle intervention aimed at adults at increased risk of T2DM and/or CVD could result in cost savings over a two-year period. However, due to methodological uncertainty no advice can be given regarding the implementation of the intervention in Dutch general practices.
Trial registration
Current Controlled Trials ISRCTN59358434.
doi:10.1186/1471-2296-14-45
PMCID: PMC3662579  PMID: 23557482
Cost-effectiveness; Cost-utility; General practitioner; Lifestyle counseling; Practice nurse
13.  Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: A structured report of real-world applicability 
Contemporary clinical trials  2012;34(1):126-135.
Background
Although the Diabetes Prevention Program (DPP) lifestyle intervention reduced type 2 diabetes incidence by 58% among high-risk adults at academic centers, it requires translation into typical primary care settings. Using baseline data from the Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE) randomized controlled trial, we evaluated the potential of its two DPP-based interventions to reach their target populations and be adopted into routine use.
Methods
Overweight/obese adults with increased cardiometabolic risk enrolled from one primary care clinic. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model, we assessed reach with data on patient identification, participation, and representativeness, and adoption with data on intervention feasibility and potential for organizational diffusion.
Results
The target population was identified by searching electronic health records. Contact was attempted for 2391 patients who completed initial screening by phone (56% uptake) or online (44%). Most (88%) of those screened ineligible were not within the target population; 12% were excluded because of research requirements. Conservatively estimated participation rate was 44%. Participants (n=241) included 54% men and had a mean (SD) age of 52.9 years (10.6) and body mass index of 32 kg/m2 (5.4). Regarding adoption, all clinic physicians agreed to participate. The feasibility of intervention implementation and dissemination was enhanced by leveraging existing intervention, training, and primary care resources.
Conclusions
E-LITE's lifestyle interventions had fair-to-good potential for primary care reach and adoption. Our trial evidence and structured reporting may inform real-world implementation of translational trials by health networks, physicians, and payers.
doi:10.1016/j.cct.2012.10.007
PMCID: PMC3645977  PMID: 23124047
Behavior therapy/methods; Metabolic syndrome X/prevention and control; Obesity/therapy, overweight/therapy; Prediabetic state/therapy; Primary health care/methods; Translational medical research/methods
14.  Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project): protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations 
Background
The diabetes of many patients is managed in general practice; healthcare providers aim to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation. These measures may decrease insulin resistance, improve glycemic control, lipid abnormalities, and hypertension. They may also prevent cardiovascular disease and complications of diabetes. However, professionals do not adhere optimally to guidelines for lifestyle counseling. Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling. Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice. The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses' training on patient outcomes.
Methods/Design
A cluster, randomized, controlled trial involving 70 general practices (35 practices in the intervention arm and 35 in the control arm) starting in March 2007. A total of 700 patients with type 2 diabetes will be recruited. The patients in the intervention arm will receive care from the primary care nurse, who will receive training in an implementation strategy with motivational interviewing as the core component. Other components of this strategy will be adaptation of the diabetes protocol to local circumstances, introduction of a social map for lifestyle support, and educational and supportive tools for sustaining motivational interviewing. The control arm will be encouraged to maintain usual care. The effect measures will be the care process, metabolic parameters (glycosylated hemoglobin, blood pressure and lipids), lifestyle (diet, physical activity, smoking, and alcohol), health-related quality of life, and patients' willingness to change behaviors. The measurements will take place at baseline and after 14 months.
Discussion
Applying motivational interviewing for patients with diabetes in primary care has been studied, but to our knowledge, no other study has yet evaluated the implementation and sustainability of motivating and involving patients in day-to-day diabetes care in general practice. If this intervention proves to be effective and cost-effective, large-scale implementation of this nurse-oriented intervention will be considered and anticipated.
Trial registration
Current Controlled Trials ISRCTN68707773.
doi:10.1186/1472-6963-9-19
PMCID: PMC2646713  PMID: 19183462
15.  Shifting from glucose diagnosis to the new HbA1c diagnosis reduces the capability of the Finnish Diabetes Risk Score (FINDRISC) to screen for glucose abnormalities within a real-life primary healthcare preventive strategy 
BMC Medicine  2013;11:45.
Background
To investigate differences in the performance of the Finnish Diabetes Risk Score (FINDRISC) as a screening tool for glucose abnormalities after shifting from glucose-based diagnostic criteria to the proposed new hemoglobin (Hb)A1c-based criteria.
Methods
A cross-sectional primary-care study was conducted as the first part of an active real-life lifestyle intervention to prevent type 2 diabetes within a high-risk Spanish Mediterranean population. Individuals without diabetes aged 45-75 years (n = 3,120) were screened using the FINDRISC. Where feasible, a subsequent 2-hour oral glucose tolerance test and HbA1c test were also carried out (n = 1,712). The performance of the risk score was calculated by applying the area under the curve (AUC) for the receiver operating characteristic, using three sets of criteria (2-hour glucose, fasting glucose, HbA1c) and three diagnostic categories (normal, pre-diabetes, diabetes).
Results
Defining diabetes by a single HbA1c measurement resulted in a significantly lower diabetes prevalence (3.6%) compared with diabetes defined by 2-hour plasma glucose (9.2%), but was not significantly lower than that obtained using fasting plasma glucose (3.1%). The FINDRISC at a cut-off of 14 had a reasonably high ability to predict diabetes using the diagnostic criteria of 2-hour or fasting glucose (AUC = 0.71) or all glucose abnormalities (AUC = 0.67 and 0.69, respectively). When HbA1c was used as the primary diagnostic criterion, the AUC for diabetes detection dropped to 0.67 (5.6% reduction in comparison with either 2-hour or fasting glucose) and fell to 0.55 for detection of all glucose abnormalities (17.9% and 20.3% reduction, respectively), with a relevant decrease in sensitivity of the risk score.
Conclusions
A shift from glucose-based diagnosis to HbA1c-based diagnosis substantially reduces the ability of the FINDRISC to screen for glucose abnormalities when applied in this real-life primary-care preventive strategy.
doi:10.1186/1741-7015-11-45
PMCID: PMC3621796  PMID: 23438147
Type 2 diabetes; screening; impaired fasting glucose; impaired glucose tolerance; pre-diabetes; FINDRISC; primary healthcare
16.  No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial 
Abstract
Objective
To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care.
Design and setting
Cluster randomised trial in general practices.
Intervention
Nurse-led structured diabetes care with a protocol, record keeping, reminders, and feedback, plus training in motivational interviewing and agenda setting.
Subjects
Primary care nurses in 58 general practices and their 940 type 2 diabetes patients with an HbA1c concentration above 7%, and a body mass index (BMI) above 25 kg/m2.
Main outcome measures
HbA1c, diet, and physical activity (medical records and patient questionnaires).
Results
Multilevel linear and logistic regression analyses adjusted for baseline outcomes showed that despite active nurse participation in the intervention, the comprehensive programme was no more effective than usual care after 14 months, as shown by HbA1c levels (difference between groups = 0.13; CI 20.8–0.35) and diet (fat (difference between groups = 0.19; CI 20.82–1.21); vegetables (difference between groups = 0.10; CI-0.21–0.41); fruit (difference between groups = 20.02; CI 20.26–0.22)), and physical activity (difference between groups = 21.15; CI 212.26–9.97), or any of the other measures of clinical parameters, patient's readiness to change, or quality of life.
Conclusion
A comprehensive programme that integrated lifestyle counselling based on motivational interviewing principles integrated into structured diabetes care did not alter HbA1c or the lifestyle related to diet and physical activity. We thus question the impact of motivational interviewing in terms of its ability to improve routine diabetes care in general practice.
doi:10.3109/02813432.2013.797178
PMCID: PMC3656395  PMID: 23659710
General practice; lifestyle; primary health care; quality of health care; randomised controlled trial; the Netherlands; type 2 diabetes mellitus
17.  Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL) 
Background
Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences.
Methods
RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers.
Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group.
Discussion
To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also provides an opportunity to focus upon the health of the next generation. The study is expected to produce novel information on the optimal timing and setting of interventions and for allocating resources to prevent obesity and diabetes in women of reproductive age.
Trial registration
Clinicaltrials.gov Identifier: NCT01698385
doi:10.1186/1471-2393-14-70
PMCID: PMC3928878  PMID: 24524674
Gestational diabetes; Type 2 diabetes; Diet and exercise intervention; Obesity; BMI; Pregnancy
18.  Motivational interviewing for modifying diabetes risk: a randomised controlled trial 
Background
Around 10–15% of adults aged over 40 years have pre-diabetes, which carries a high risk of progression to type 2 diabetes. Intensive lifestyle intervention reduces progression by as much as 58%. However, the cost and personnel requirements of these interventions are major obstacles to delivery in NHS primary care.
Aim
To assess the effectiveness of a low-cost intervention, delivered in primary care by non-NHS staff, to reduce the risk of diabetes through weight loss and physical activity.
Design of study
Pragmatic single-blind randomised controlled trial with researchers and statistician blinded to group allocation.
Setting
UK primary care.
Method
One-hundred and forty-one participants with a body mass index of 28 kg/m2 or more, but without diabetes or heart disease, received either information leaflets or individual behavioural counselling using motivational interviewing techniques. The intervention was delivered by five counsellors recruited from the local community. The primary outcomes were the proportions of participants meeting predefined targets for weight loss (5%) and moderate physical activity (150 minutes/week) after 6 months.
Results
Using intention-to-treat analysis, more people in the intervention group achieved the weight-loss target (24% versus 7% for controls; odds ratio [OR] = 3.96; 95% confidence interval [Cl] = 1.4 to 11.4; number needed to treat [NNT] = 6.1 (95% Cl = 4 to 21). The proportion achieving the physical activity target did not increase significantly (38% versus 28% for controls; OR = 1.6; 95% Cl = 0.7 to 3.8).
Conclusion
Short-term weight loss, at a level which, if sustained, is clinically meaningful for reducing diabetes risk, is achievable in primary care, without excessive use of NHS monetary or personnel resources.
doi:10.3399/bjgp08X319648
PMCID: PMC2566518  PMID: 18682011
behaviour therapy; diabetes mellitus; intervention studies; primary prevention; randomised controlled trial; weight loss
19.  Feasibility and effectiveness of a targeted diabetes prevention program for 18 to 60-year-old South Asian migrants: design and methods of the DH!AAN study 
BMC Public Health  2012;12:371.
Background
South Asian migrants are at particularly high risk of type 2 diabetes. Previous studies have shown that intensive lifestyle interventions may prevent the onset of diabetes. Such interventions have not been culturally adapted and evaluated among South Asians in industrialized countries. Therefore, we have set up a randomized controlled trial to study the effectiveness of a targeted lifestyle intervention for the risk of type 2 diabetes and cardiovascular risk factors among 18 to 60-year-old Hindustani Surinamese (South Asians) in The Hague, the Netherlands. Here we present the study design and describe the characteristics of those recruited.
Methods
Between May 18, 2009 and October 11, 2010, we screened 2307 Hindustani Surinamese (18–60 years old) living in The Hague. We sent invitations to participate to those who had an impaired fasting glucose of 5.6-6.9 mmol/l, an impaired glucose tolerance of 7.8-11.0 mmol/L, a glycated hemoglobin level of 6.0% or more and/or a value of 2.39 or more for the homeostasis model assessment of estimated insulin resistance. In total, 536 people (56.1% of those eligible) participated. People with a higher level of education and a family history of type 2 diabetes were more likely to participate. The control and intervention groups were similar with regard to important background characteristics. The intervention group will receive a culturally targeted intervention consisting of dietary counseling using motivational interviewing and a supervised physical activity program. The control group will receive generic lifestyle advice. To determine the effectiveness, a physical examination (anthropometrics, cardiorespiratory test, lipid profile, and measures of oral glucose tolerance, glycated hemoglobin, and insulin) and interview (physical activity, diet, quality of life, and intermediate outcomes) were carried out at baseline and will be repeated at 1 year and 2 years. The process and the costs will be evaluated.
Discussion
This trial will provide insight into the feasibility and effectiveness of a targeted, intensive, lifestyle intervention for the risk of type 2 diabetes and cardiovascular risk factors among 18 to 60-year-old South Asians.
Trial registration
Dutch Trial Register: NTR1499
doi:10.1186/1471-2458-12-371
PMCID: PMC3504520  PMID: 22621376
20.  Comparing the effectiveness of two cardiovascular prevention programmes for highly educated professionals in general practice: a randomised clinical trial 
Background
Cardiovascular disease is a major cause of mortality and morbidity and its prevalence is set to increase. While the benefits of medical and lifestyle interventions are established, the effectiveness of interventions which seek to improve the way preventive care is delivered in general practice is less so. The aim was to study and to compare the effectiveness of 2 intervention programmes for reducing cardiovascular risk factors within general practice.
Methods
A randomised controlled trial was conducted in Belgium between 2007-2010 with 314 highly educated and mainly healthy professionals allocated to a medical (MP) or a medical + lifestyle (MLP) programme. The MP consisted of medical assessments (screening and follow-up) and the MLP added a tailored lifestyle change programme (web-based and individual coaching) to the MP. Primary outcomes were total cholesterol, blood pressure, and body mass index (BMI). The secondary outcomes were smoking status, fitness-score, and total cardiovascular risk.
Results
The mean age was 41 years, 95 (32%) participants were female, 7 had a personal cardiovascular event in their medical history and 3 had diabetes. There were no significant differences found between MP and MLP in primary or secondary outcomes. In both study conditions decreases of cholesterol, systolic blood pressure, and diastolic blood pressure were found. Unfavourable increases were found for BMI (p < .05). A significant decrease of the overall cardiovascular risk was reported (p < .001).
Conclusions
Both interventions are effective in reducing cardiovascular risk. In our population the combined medical and lifestyle programme was not superior to the medical programme.
Trial registration
ISRCTN23940498
doi:10.1186/1471-2261-13-38
PMCID: PMC3674968  PMID: 23725092
Cardiovascular diseases; Prevention; General practice; Lifestyle programmes
21.  Preventing Diabetes in the Clinical Setting 
Objective
Translating lessons from clinical trials on the prevention or delay of type 2 diabetes to populations in nonstudy settings remains a challenge. The purpose of this paper is to review, from the perspective of practicing clinicians, available evidence on lifestyle interventions or medication to prevent or delay the onset of type 2 diabetes.
Design
A MEDLINE search identified 4 major diabetes prevention trials using lifestyle changes and 3 using prophylactic medications. We reviewed the study design, key components, and outcomes for each study, focusing on aspects of the interventions potentially adaptable to clinical settings.
Results
The lifestyle intervention studies set modest goals for weight loss and physical activity. Individualized counseling helped participants work toward their own goals; behavioral contracting and self-monitoring were key features, and family and social context were emphasized. Study staff made vigorous follow-up efforts for subjects having less success. Actual weight loss by participants was modest; yet, the reduction in diabetes incidence was quite significant. Prophylactic medication also reduced diabetes risk; however, lifestyle changes were more effective and are recommended as first-line strategy. Cost-effectiveness analyses have shown both lifestyle and medication interventions to be beneficial, especially as they might be implemented in practice.
Conclusion
Strong evidence exists for the prevention or delay of type 2 diabetes through lifestyle changes. Components of these programs may be adaptable for use in clinical settings. This evidence supports broader implementation and increased reimbursement for provider services related to nutrition and physical activity to forestall morbidity from type 2 diabetes.
doi:10.1111/j.1525-1497.2005.0277.x
PMCID: PMC1484626  PMID: 16423130
type 2 diabetes; prevention; lifestyle; nutrition; physical activity
22.  Lifestyle Change: A Critical Look 
Canadian Family Physician  1989;35:1873-1879.
Many relationships between behaviour and disease are now recognized by both health care professionals and the public. In lifestyle counselling, caregivers help patients to change their unhealthy habits. The primary care office seems an ideal setting for implementing behaviour change strategies, but studies suggest that physicians only sporadically elicit behavioural risk factors and infrequently counsel patients to modify risky behaviours. Physicians have been introduced to the goals of clinical prevention, but with the limited application of clinical prevention research to practical office approaches, they often lack the necessary knowledge and skills to achieve them. The individual intervention and group program strategies described in this paper have been adapted to the primary care setting, and we hope they will help family physicians to play an effective role in lifestyle change.
PMCID: PMC2280867
counselling; diet; exercise; lifestyle; physician-patient relationship; preventive medicine; smoking
23.  An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial) 
BMC Nursing  2010;9:4.
Background
Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP) are the main behavioural risk factors for chronic disease. Primary health care (PHC) has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors.
Methods/Design
The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison) group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1) telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2) nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3) semi-structured interviews/focus with nurses, managers and clients in 'early intervention' sites to explore the feasibility, acceptability and sustainability of the intervention.
Discussion
The study will provide evidence about the effectiveness and feasibility of brief lifestyle interventions delivered by generalist community nurses as part of routine practice. This will inform future community nursing practice and PHC policy.
Trial Registration
ACTRN12609001081202
doi:10.1186/1472-6955-9-4
PMCID: PMC2841173  PMID: 20175932
24.  Intensive Lifestyle Intervention in General Practice to Prevent Type 2 Diabetes among 18 to 60-Year-Old South Asians: 1-Year Effects on the Weight Status and Metabolic Profile of Participants in a Randomized Controlled Trial 
PLoS ONE  2013;8(7):e68605.
Aim
To study 1-year effectiveness of an intensive, culturally targeted lifestyle intervention in general practice for weight status and metabolic profile of South-Asians at risk of type 2 diabetes.
Methods
536 South-Asians at risk of type 2 diabetes were randomized to an intervention (n = 283) or control (n = 253) group. The intervention, which was targeted culturally to the South-Asian population, consisted of individual lifestyle counselling, a family session, cooking classes, and supervised physical activity programme. All components of the intervention were carried out by professionals as part of their daily clinical practice. The control group received generic lifestyle advice. Change in weight status and metabolic profile were assessed after 1 year.
Results
After 1 year, 201 participants were lost to follow-up. Remaining participants in intervention (n = 177) and control (n = 158) group had similar baseline characteristics. Weight loss in the intervention group was 0.2±3.3 kg, weight gain in the control group was 0.4±3.1 kg (p = 0.08). Changes in other weight-related measurements did not differ significantly between groups. Furthermore, there were no differences between groups in changes of metabolic profile. All results remained similar after repeating analyses in a multiple imputed dataset.
Discussion
An intensive, culturally targeted, lifestyle intervention of 1 year did not improve weight status and metabolic profile of South-Asians at risk of type 2 diabetes. The laborious recruitment, high drop-out, and lack of effectiveness emphasise the difficulty of realising health benefits in practice and suggest that this strategy might not be the optimal approach for this population.
Trial Registration
Nederlands Trial Register NTR1499
doi:10.1371/journal.pone.0068605
PMCID: PMC3718785  PMID: 23894322
25.  Features of the Chronic Care Model associated with behavioral counseling and diabetes care in community primary care 
Background
The Chronic Care Model (CCM) was developed to improve chronic disease care, but may also inform other types of preventive care delivery. Using hierarchical analyses of service delivery to patients, we explore associations of CCM implementation with diabetes care and counseling for diet or weight loss and physical activity in community-based primary care offices.
Methods
Secondary analysis focused on baseline data from 25 practices (with an average of four physicians per practice) participating in an intervention trial targeting improved colorectal cancer screening rates. This intervention made no reference to the CCM. CCM implementation (measured through staff and clinical management surveys) and was associated with patient care indicators (chart audits and patient questionnaires).
Results
Overall, practices had low levels of CCM implementation. However, higher levels of CCM implementation were associated with better diabetes assessment and treatment of patients (p=0.009, 0.015), particularly in practices open to “innovation”. Physical activity counseling for obese and particularly overweight patients was strongly associated with CCM implementation (p=0.0017), particularly among practices open to “innovation”; however, this association did not hold for overweight and obese patients with diabetes.
Conclusions
Very modest levels of CCM implementation in unsupported primary care practices are associated with improved care for patients with diabetes and higher rates of behavioral counseling. Incremental incorporation of CCM components is an option, especially for resource stretched community practices with cultures of “innovativeness.”
doi:10.3122/jabfm.2010.03.090141
PMCID: PMC2924566  PMID: 20453175
care delivery system; chronic care; health promotion; obesity; organizational design; primary care

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