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1.  Implementation of a lifestyle intervention for type 2 diabetes prevention in Dutch primary care: opportunities for intervention delivery 
BMC Family Practice  2012;13:79.
Background
As in clinical practice resources may be limited compared to experimental settings, translation of evidence-based lifestyle interventions into daily life settings is challenging. In this study we therefore evaluated the implementation of the APHRODITE lifestyle intervention for the prevention of type 2 diabetes in Dutch primary care. Based on this evaluation we discuss opportunities for refining intervention delivery.
Methods
A 2.5-year intervention was performed in 14 general practices in the Netherlands among individuals at high risk for type 2 diabetes (FINDRISC-score ≥ 13) (n = 479) and was compared to usual care (n = 446). Intervention consisted of individual lifestyle counselling by nurse practitioners (n = 24) and GPs (n = 48) and group-consultations. Drop-out and attendance were registered during the programme. After the intervention, satisfaction with the programme and perceived implementation barriers were assessed with questionnaires.
Results
Drop-out was modest (intervention: 14.6 %; usual care: 13.2 %) and attendance at individual consultations was high (intervention: 80-97 %; usual care: 86-94 %). Providers were confident about diabetes prevention by lifestyle intervention in primary care. Participants were more satisfied with counselling from nurse practitioners than from GPs. A major part of the GPs reported low self-efficacy regarding dietary guidance. Lack of counselling time (60 %), participant motivation (12 %), and financial reimbursement (11 %) were regarded by providers as important barriers for intervention implementation.
Conclusions
High participant compliance and a positive attitude of providers make primary care a suitable setting for diabetes prevention by lifestyle counselling. Results support a role for the nurse practitioner as the key player in guiding lifestyle modification. Further research is needed on strategies that could increase cost-effectiveness, such as more stringent criteria for participant inclusion, group-counselling, more tailor-made counselling and integration of screening and / or interventions for different disorders.
doi:10.1186/1471-2296-13-79
PMCID: PMC3457845  PMID: 22873753
Type 2 diabetes; Primary care; Lifestyle intervention; Implementation
2.  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
3.  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
4.  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
5.  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
6.  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
7.  Prevention of Type 2 Diabetes by lifestyle intervention in an Australian primary health care setting: Greater Green Triangle (GGT) Diabetes Prevention Project 
BMC Public Health  2007;7:249.
Background
Randomised controlled trials demonstrate a 60% reduction in type 2 diabetes incidence through lifestyle modification programmes. The aim of this study is to determine whether such programmes are feasible in primary health care.
Methods
An intervention study including 237 individuals 40–75 years of age with moderate or high risk of developing type 2 diabetes. A structured group programme with six 90 minute sessions delivered during an eight month period by trained nurses in Australian primary health care in 2004–2006. Main outcome measures taken at baseline, three, and 12 months included weight, height, waist circumference, fasting plasma glucose and lipids, plasma glucose two hours after oral glucose challenge, blood pressure, measures of psychological distress and general health outcomes. To test differences between baseline and follow-up, paired t-tests and Wilcoxon rank sum tests were performed.
Results
At twelve months participants' mean weight reduced by 2.52 kg (95% confidence interval 1.85 to 3.19) and waist circumference by 4.17 cm (3.48 to 4.87). Mean fasting glucose reduced by 0.14 mmol/l (0.07 to 0.20), plasma glucose two hours after oral glucose challenge by 0.58 mmol/l (0.36 to 0.79), total cholesterol by 0.29 mmol/l (0.18 to 0.40), low density lipoprotein cholesterol by 0.25 mmol/l (0.16 to 0.34), triglycerides by 0.15 mmol/l (0.05 to 0.24) and diastolic blood pressure by 2.14 mmHg (0.94 to 3.33). Significant improvements were also found in most psychological measures.
Conclusion
This study provides evidence that a type 2 diabetes prevention programme using lifestyle intervention is feasible in primary health care settings, with reductions in risk factors approaching those observed in clinical trials.
Trial Number
Current Controlled Trials ISRCTN38031372
doi:10.1186/1471-2458-7-249
PMCID: PMC2039742  PMID: 17877832
8.  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
9.  The prevention of type 2 diabetes: general practitioner and practice nurse opinions 
Background: Primary prevention of type 2 diabetes is now possible with lifestyle or pharmacological interventions in people who are at risk. Primary care would seem to be the legitimate setting for this to take place.
Aim: To explore the views of general practitioners and practice nurses about the detection and management of people at risk of developing type 2 diabetes.
Design of study: Qualitative study.
Setting: One local health board area in Wales.
Method: General practitioners and practice nurses participated in multi-professional focus groups, and opinions of participants were analysed into themes and sub-themes according to focus group content analysis methodology to search for ‘markers of text’.
Results: Participants from 21 practices were involved. Participants' opinions on the detection and management of individuals at risk of developing type 2 diabetes were polarised into those who considered these activities inappropriate for primary care and those who were already engaged in the detection, management and follow-up of these individuals. For the former, existing workload, the questionable role of primary care as a ‘screening service’, lack of resources, and conflict and concern about increasing specialisation were given as justification. Those already engaged in these activities emphasised their importance but were also concerned with the lack of available resources. Other concerns were the perceived low motivation of patients to modify their lifestyle and the unnecessary medicalisation of the precursor conditions of impaired glucose tolerance and impaired fasting glycaemia. The prevention of type 2 diabetes was seen as largely the responsibility of other agencies such as health promotion and education.
Conclusion: The often strongly held views about this topic are at least partly influenced by current pressures on primary care. To make the primary prevention of type 2 diabetes a reality, either practitioners need to be motivated and resourced to carry out preventive strategies or alternative methods must be identified.
PMCID: PMC1324806  PMID: 15239916
diabetes mellitus, type II; primary prevention; nurses; qualitative research; focus groups
10.  General effect on high-risk persons when general practitioners are trained in intensive treatment of type 2 diabetes 
Objective
Within the frame of a randomized clinical trial to examine whether training of general practitioners (the intervention group) in intensive lifestyle modification and pharmacological treatment of patients with type 2 diabetes has a spillover effect on individuals with impaired fasting glycaemia (IFG) or impaired glucose tolerance (IGT).
Design
A high-risk screening study for type 2 diabetes with an intervention programme, where general practices were randomized to provide standard treatment versus intensive lifestyle modification and pharmacological treatment to newly diagnosed diabetic patients.
Setting
General practices in Denmark.
Subjects
Of 1821 individuals identified with IFG or IGT, results from oral glucose tolerance tests after one and three years were available in 1510 individuals.
Main outcome measures
Progression rates from IFG and IGT to diabetes and effect of intervention were estimated in a regression model using interval censoring.
Results
A total of 442 persons developed diabetes. There was no significant overall effect of intervention on progression rates. For risk factors, no difference in rate of change was found between randomization groups, but a difference was found between general practices within the same randomization groups.
Conclusion
General practitioners identify a high number of incident diabetes cases in individuals with IFG or IGT found by high-risk screening. Intervention at the general practitioner's level in intensive treatment type 2 diabetes does not have a significant spillover effect reducing the risk of diabetes from pre-diabetic conditions. This could indicate that intervention strategies should be specifically targeted at individuals with IFG or IGT, either by training general practitioners or directly at the individual level.
doi:10.1080/02813430802264624
PMCID: PMC3409605  PMID: 18677673
Clustering; family practice; general practice; impaired fasting glucose; impaired glucose tolerance; intervention studies; risk management; type 2 diabetes
11.  Health improvement and prevention study (HIPS) - evaluation of an intervention to prevent vascular disease in general practice 
BMC Family Practice  2010;11:57.
Background
The Health Improvement and Prevention Study (HIPS) study aims to evaluate the capacity of general practice to identify patients at high risk for developing vascular disease and to reduce their risk of vascular disease and diabetes through behavioural interventions delivered in general practice and by the local primary care organization.
Methods/Design
HIPS is a stratified randomized controlled trial involving 30 general practices in NSW, Australia. Practices are randomly allocated to an 'intervention' or 'control' group. General practitioners (GPs) and practice nurses (PNs) are offered training in lifestyle counselling and motivational interviewing as well as practice visits and patient educational resources. Patients enrolled in the trial present for a health check in which the GP and PN provide brief lifestyle counselling based on the 5As model (ask, assess, advise, assist, and arrange) and refer high risk patients to a diet education and physical activity program. The program consists of two individual visits with a dietician or exercise physiologist and four group sessions, after which patients are followed up by the GP or PN. In each practice 160 eligible patients aged between 40 and 64 years are invited to participate in the study, with the expectation that 40 will be eligible and willing to participate. Evaluation data collection consists of (1) a practice questionnaire, (2) GP and PN questionnaires to assess preventive care attitudes and practices, (3) patient questionnaire to assess self-reported lifestyle behaviours and readiness to change, (4) physical assessment including weight, height, body mass index (BMI), waist circumference and blood pressure, (5) a fasting blood test for glucose and lipids, (6) a clinical record audit, and (7) qualitative data collection. All measures are collected at baseline and 12 months except the patient questionnaire which is also collected at 6 months. Study outcomes before and after the intervention is compared between intervention and control groups after adjusting for baseline differences and clustering at the level of the practice.
Discussion
This study will provide evidence of the effectiveness of a primary care intervention to reduce the risk of cardiovascular disease and diabetes in general practice patients. It will inform current policies and programs designed to prevent these conditions in Australian primary health care.
Trial Registration
ACTRN12607000423415
doi:10.1186/1471-2296-11-57
PMCID: PMC2923104  PMID: 20687956
12.  Factors influencing participant enrolment in a diabetes prevention program in general practice: lessons from the Sydney diabetes prevention program 
BMC Public Health  2012;12:822.
Background
The effectiveness of lifestyle interventions in reducing diabetes incidence has been well established. Little is known, however, about factors influencing the reach of diabetes prevention programs. This study examines the predictors of enrolment in the Sydney Diabetes Prevention Program (SDPP), a community-based diabetes prevention program conducted in general practice, New South Wales, Australia from 2008–2011.
Methods
SDPP was an effectiveness trial. Participating general practitioners (GPs) from three Divisions of General Practice invited individuals aged 50–65 years without known diabetes to complete the Australian Type 2 Diabetes Risk Assessment tool. Individuals at high risk of diabetes were invited to participate in a lifestyle modification program. A multivariate model using generalized estimating equations to control for clustering of enrolment outcomes by GPs was used to examine independent predictors of enrolment in the program. Predictors included age, gender, indigenous status, region of birth, socio-economic status, family history of diabetes, history of high glucose, use of anti-hypertensive medication, smoking status, fruit and vegetable intake, physical activity level and waist measurement.
Results
Of the 1821 eligible people identified as high risk, one third chose not to enrol in the lifestyle program. In multivariant analysis, physically inactive individuals (OR: 1.48, P = 0.004) and those with a family history of diabetes (OR: 1.67, P = 0.000) and history of high blood glucose levels (OR: 1.48, P = 0.001) were significantly more likely to enrol in the program. However, high risk individuals who smoked (OR: 0.52, P = 0.000), were born in a country with high diabetes risk (OR: 0.52, P = 0.000), were taking blood pressure lowering medications (OR: 0.80, P = 0.040) and consumed little fruit and vegetables (OR: 0.76, P = 0.047) were significantly less likely to take up the program.
Conclusions
Targeted strategies are likely to be needed to engage groups such as smokers and high risk ethnic groups. Further research is required to better understand factors influencing enrolment in diabetes prevention programs in the primary health care setting, both at the GP and individual level.
doi:10.1186/1471-2458-12-822
PMCID: PMC3549936  PMID: 23006577
Diabetes prevention; Program participation; Enrolment; Risk factors; Research translation
13.  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
14.  Ten-Year Mortality and Cardiovascular Morbidity in the Finnish Diabetes Prevention Study—Secondary Analysis of the Randomized Trial 
PLoS ONE  2009;4(5):e5656.
Background
The Finnish Diabetes Prevention Study (DPS) was a randomized controlled trial, which showed that it is possible to prevent type 2 diabetes by lifestyle changes. The aim of the present study was to examine whether the lifestyle intervention had an effect on the ten-year mortality and cardiovascular morbidity in the DPS participants originally randomized either into an intervention or control group. Furthermore, we compared these results with a population-based cohort comprising individuals of varying glucose tolerance states.
Methods and Findings
Middle-aged, overweight people with IGT (n = 522) were randomized into intensive intervention (including physical activity, weight reduction and dietary counseling), or control “mini-intervention” group. Median length of the intervention period was 4 years and the mean follow-up was 10.6 years. The population-based reference study cohort included 1881 individuals (1570 with normal glucose tolerance, 183 with IGT, 59 with screen-detected type 2 diabetes, 69 with previously known type 2 diabetes) with the mean follow-up of 13.8 years. Mortality and cardiovascular morbidity data were collected from the national Hospital Discharge Register and Causes of Death Register. Among the DPS participants who consented for register linkage (n = 505), total mortality (2.2 vs. 3.8 per 1000 person years, hazard ratio HR = 0.57, 95% CI 0.21–1.58) and cardiovascular morbidity (22.9 vs. 22.0 per 1000 person years, HR = 1.04, 95% CI 0.72–1.51) did not differ significantly between the intervention and control groups. Compared with the population-based cohort with impaired glucose tolerance, adjusted HRs were 0.21 (95% CI 0.09–0.52) and 0.39 (95% CI 0.20–0.79) for total mortality, and 0.89 (95% CI 0.62–1.27) and 0.87 (0.60–1.27) for cardiovascular morbidity in the intervention and control groups of the DPS, respectively. The risk of death in DPS combined cohort was markedly lower than in FINRISK IGT cohort (adjusted HR 0.30, 95% CI 0.17–0.54), but there was no significant difference in the risk of CVD (adjusted HR 0.88, 95% CI 0.64–1.21).
Conclusions
Lifestyle intervention among persons with IGT did not decrease cardiovascular morbidity during the first 10 years of follow-up. However, the statistical power may not be sufficient to detect small differences between the intervention and control groups. Low total mortality among participants of the DPS compared with individuals with IGT in the general population could be ascribed to a lower cardiovascular risk profile at baseline and regular follow-up.
Trial Registration
ClinicalTrials.gov NCT00518167
doi:10.1371/journal.pone.0005656
PMCID: PMC2682577  PMID: 19479072
15.  Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial 
Trials  2013;14:339.
Background
Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.
Methods/Design
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.
Discussion
This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.
Trial registration
Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066
doi:10.1186/1745-6215-14-339
PMCID: PMC3853589  PMID: 24135085
Gestational diabetes; Post-natal; Lifestyle intervention; Type 2 diabetes prevention
16.  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
17.  Cardiometabolic risk reduction through lifestyle intervention programs in the Brazilian public health system 
Public health strategies to reduce cardiovascular morbidity and mortality should focus on global cardiometabolic risk reduction. The efficacy of lifestyle changes to prevent type 2 diabetes have been demonstrated, but low-cost interventions to reduce cardiometabolic risk in Latin-America have been rarely reported. Our group developed 2 programs to promote health of high-risk individuals attending a primary care center in Brazil. This study compared the effects of two 9-month lifestyle interventions, one based on medical consultations (traditional) and another with 13 multi-professional group sessions in addition to the medical consultations (intensive) on cardiometabolic parameters. Adults were eligible if they had pre-diabetes (according to the American Diabetes Association) and/or metabolic syndrome (International Diabetes Federation criteria for Latin-America). Data were expressed as means and standard deviations or percentages and compared between groups or testing visits. A p-value < 0.05 was considered significant. Results: 180 individuals agreed to participate (35.0% men, mean age 54.7 ± 12.3 years, 86.1% overweight or obese). 83 were allocated to the traditional and 97 to the intensive program. Both interventions reduced body mass index, waist circumference and tumor necrosis factor-α. Only intensive program reduced 2-hour plasma glucose and blood pressure and increased adiponectin values, but HDL-cholesterol increased only in the traditional. Also, responses to programs were better in intensive compared to traditional program in terms of blood pressure and adiponectin improvements. No new case of diabetes in intensive but 3 cases and one myocardial infarction in traditional program were detected. Both programs induced metabolic improvement in the short-term, but if better results in the intensive are due to higher awareness about risk and self-motivation deserves further investigation. In conclusion, these low-cost interventions are able to minimize cardiometabolic risk factors involved in the progression to type 2 diabetes and/or cardiovascular disease.
doi:10.1186/1758-5996-5-21
PMCID: PMC3706232  PMID: 23597156
Lifestyle intervention; Pre-diabetes; Metabolic syndrome; Cardiometabolic risk; Public health system
18.  Perceiving Need for Lifestyle Counseling 
Diabetes Care  2012;35(2):239-241.
OBJECTIVE
To investigate the proportion of individuals at high risk of type 2 diabetes who perceive the need for lifestyle counseling, factors associated with this perception, and whether the perceived need is associated with subsequent attendance in lifestyle intervention.
RESEARCH DESIGN AND METHODS
Baseline and intervention data were obtained from 10,149 participants in a Finnish National Diabetes Prevention Project.
RESULTS
In total, 36% of men and 52% of women perceived the need for counseling. Most of the risk factors did not increase the perceived need for counseling. Those agreeing to attend supervised lifestyle intervention were more likely to report a perceived need than those who agreed on a self-initiated lifestyle change or those who refused to attend lifestyle intervention. The perceived need was associated with actual attendance in the lifestyle intervention only among women.
CONCLUSIONS
It will be vital to find additional means to support lifestyle change.
doi:10.2337/dc11-1116
PMCID: PMC3263895  PMID: 22190673
19.  Prevention of type 2 diabetes in adults with impaired glucose tolerance: the European Diabetes Prevention RCT in Newcastle upon Tyne, UK 
BMC Public Health  2009;9:342.
Background
Diabetes prevalence is increasing. The Finnish Diabetes Prevention Study (DPS) showed a 58% reduction in Type 2 Diabetes (T2D) incidence in adults with impaired glucose tolerance (IGT). The European Diabetes Prevention Study (EDIPS) extends the DPS to different European populations, using the same study design. In the Newcastle arm of this study (EDIPS-Newcastle), we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence.
Methods
We recruited 102 participants (42 men and 60 women, mean age 57 years, mean BMI 34 kgm-2) with IGT to EDIPS-Newcastle and randomised to Intervention and usual care Control groups. The intervention included individual motivational interviewing aimed at: weight reduction, increase in physical activity, fibre and carbohydrate intake and reduction of fat intake (secondary outcomes). The primary outcome was diagnosis of T2D.
Results
Mean duration of follow-up was 3.1 years. T2D was diagnosed in 16 participants (I = 5, C = 11). Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group. The overall incidence of diabetes was reduced by 55% in the Intervention-group, compared with the Control-group: RR 0.45 (95%CI 0.2 to 1.2).
Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D.
Conclusion
Our results are consistent with other diabetes prevention trials. This study was designed as part of a larger study and although the sample size limits statistical significance, the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT. In explanatory analysis small sustained beneficial changes in weight, physical activity or dietary factors were associated with reduction in T2D incidence.
Trial Registration
International Standard Randomised Controlled Trial Number registry (ISRCTN)
Registry number: ISRCTN 15670600
doi:10.1186/1471-2458-9-342
PMCID: PMC2760530  PMID: 19758428
20.  Do statins interfere with lifestyle intervention in the prevention of diabetes in primary healthcare? One-year follow-up of the FIN-D2D project 
BMJ Open  2012;2(5):e001472.
Objectives
To examine whether the use of statins is associated with the incidence of type 2 diabetes (T2D) and changes in glucose metabolism among individuals at high risk for T2D participating in 1-year lifestyle intervention in primary healthcare setting.
Design
Prospective follow-up study.
Setting
In all, 400 primary healthcare centres and occupational healthcare clinics in Finland.
Participants
We screened altogether 10 149 individuals at increased risk for T2D; of these, 2798 non-diabetic individuals verified by a 2 h glucose tolerance test participated in the 1-year follow-up.
Interventions
Lifestyle intervention (individual and/or group-based counselling).
Primary outcome measures
Incidence of T2D and fasting and 2 h glucose measured at baseline and follow-up.
Results
A total of 484 individuals (17.3%) used statins at the baseline. Of them 31 (7.5%) developed T2D during the follow-up, compared to 126 (6.5%) of statin non-users (OR 1.17, 95% CI 0.78 to 1.76, p=0.442). Interestingly, fasting glucose increased by 0.08 mmol/l in statin users, but remained unchanged in non-users, the difference being 0.074 mmol/l (95% CI 0.014 to 0.134) and remained significant even after adjustment for age, sex, baseline fasting glucose, the presence of cardiovascular disease (CVD), use of antihypertensive and/or coronary artery disease medication, weight and 1-year weight change (adjusted p=0.042).
Conclusions
The incidence of T2D did not differ between the statin users and non-users. The finding that fasting glucose slightly increased in statin users in spite of lifestyle interventions suggests the view that the use of statins might have unfavourable effects on glucose metabolism and that statins might hamper beneficial effects of lifestyle intervention in people at high risk of T2D.
doi:10.1136/bmjopen-2012-001472
PMCID: PMC3467638  PMID: 22983785
Preventive Medicine; Primary Care
21.  An innovative approach to providing lifestyle education and behaviour change to prevent type 2 diabetes 
Introduction
Diabetes is one of the major health challenges of our time. Diabetes UK recently estimated 10% of the total NHS budget is spent on diabetes care. NICE guidance “Prevention of type 2 diabetes in adults” (2011) and “Prevention of type 2 diabetes in high-risk groups” (currently consultation phase) emphasises the importance of prevention. Impaired glucose tolerance (IGT) is a precursor for the development of type 2 diabetes and is additionally associated with increased cardiovascular risk. Positive lifestyle changes (healthy eating, increased activity, weight reduction) have been proven to prevent or delay onset of type 2 diabetes in people diagnosed with IGT.
Aims and objectives
Working together, Greater Manchester CLAHRC and Salford’s NHS Diabetes Care Call team developed a six-month, telephone-based, lifestyle intervention programme for people with IGT. The aim was to provide a convenient, accessible and tailored service that would motivate and enable people to make positive behaviour changes to prevent or delay onset of type 2 diabetes. The programme was delivered by a team of trained health advisors who provided standardised, evidence-based education via a series of electronic scripts developed and maintained by the specialist diabetes team. Supporting resources, including a patient education leaflet and DVD designed in-house, were sent by post. Health advisors worked on an individual basis with participants and had access to an online directory of local services and groups to signpost appropriately. The project ran from May 2010 to January 2011, enrolling 55 people with IGT from seven GP practices in Salford. All calls were recorded on the electronic patient record, viewable across primary and secondary care.
Key results
All 55 participants completed the pathway.
Clinical Outcomes:
52% (n=26) reverted to normal fasting and glucose tolerance.
10% (n=5) reduced risk to impaired fasting glucose.
75% (n=38) confirmed weight loss, average 4.8 kg (5.3%) per person.
61% (n=31) reduced FINDRISC score by average 2.1 points per person.
88% (n=48) achieved or partially achieved their overall lifestyle goal.
Qualitative outcomes (from questionnaires and focus groups):
88% (n=36) participants reported increased understanding of blood results.
78% (n=32) participants reported definite increased confidence about how to reduce their own risk of developing type 2 diabetes.
90% (n=37) felt they received relevant, up to date advice about reducing diabetes risk.
GP practices reported high-levels of confidence that the service provided evidence-based dietary and lifestyle advice and motivational support.
Large-scale research studies strongly suggest lifestyle programmes preventing diabetes are cost effective. Cost benefit analysis of this project and extrapolation for whole population shows roll out is achievable with payback on investment in year three.
Conclusion
The IGT care call service is a highly scalable and cost-effective approach to preventing diabetes and amenable for ‘hard to reach’ groups. A full evaluation report was presented to NHS Salford Commissioning Board who have since allocated further funding, allowing further expansion of the project and longer-term follow-up of participants. This project recently won a Quality in Care (QiC) Diabetes award for “Best type 2 diabetes prevention initiative” (November 2011).
PMCID: PMC3571139
diabetes prevention; telephone; lifestyle intervention
22.  Randomised controlled trial of structured personal care of type 2 diabetes mellitus 
BMJ : British Medical Journal  2001;323(7319):970.
Objective
To assess the effect of a multifaceted intervention directed at general practitioners on six year mortality, morbidity, and risk factors of patients with newly diagnosed type 2 diabetes.
Design
Pragmatic, open, controlled trial with randomisation of practices to structured personal care or routine care; analysis after 6 years.
Setting
311 Danish practices with 474 general practitioners (243 in intervention group and 231 in comparison group).
Participants
874 (90.1%) of 970 patients aged ⩾40 years who had diabetes diagnosed in 1989-91 and survived until six year follow up.
Intervention
Regular follow up and individualised goal setting supported by prompting of doctors, clinical guidelines, feedback, and continuing medical education.
Main outcome measures
Predefined clinical non-fatal outcomes, overall mortality, risk factors, and weight.
Results
Predefined non-fatal outcomes and mortality were the same in both groups. The following risk factor levels were lower for intervention patients than for comparison patients (median values): fasting plasma glucose concentration (7.9 v 8.7 mmol/l, P=0.0007), glycated haemoglobin (8.5% v 9.0%, P<0.0001; reference range 5.4-7.4%), systolic blood pressure (145 v 150 mm Hg, P=0.0004), and cholesterol concentration (6.0 v 6.1 mmol/l, P=0.029, adjusted for baseline concentration). Both groups had lost weight since diagnosis (2.6 v 2.0 kg). Metformin was the only drug used more frequently in the intervention group (24% (110/459) v 15% (61/415)).Intervention doctors arranged more follow up consultations, referred fewer patients to diabetes clinics, and set more optimistic goals.
Conclusions
In primary care, individualised goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain.
What is already known on this topicEvidence is increasing that control of hyperglycaemia, hypertension, and dyslipidaemia may postpone the development of diabetic complications in patients with type 2 diabetesMaintaining good control over a long period can be difficultWhat this study addsStructured individualised personal care with educational and surveillance support for general practitioners reduced levels of risk factors in type 2 diabetic patients after six yearsRisk factors were reduced to a level that has been shown to have a beneficial effect on diabetic complicationsParticipants also showed modest weight loss
PMCID: PMC59690  PMID: 11679387
23.  The Live Well, Be Well Study: A Community-Based, Translational Lifestyle Program to Lower Diabetes Risk Factors in Ethnic Minority and Lower–Socioeconomic Status Adults 
American Journal of Public Health  2012;102(8):1551-1558.
Objectives
We evaluated a community-based, translational lifestyle program to reduce diabetes risk in lower–socioeconomic status (SES) and ethnic minority adults.
Methods
Through an academic–public health department partnership, community-dwelling adults at risk for diabetes were randomly assigned to individualized lifestyle counseling delivered primarily via telephone by health department counselors or a wait-list control group. Primary outcomes (6 and 12 months) were fasting glucose level, triglycerides, high- and low-density lipoprotein cholesterol, weight, waist circumference, and systolic blood pressure. Secondary outcomes included diet, physical activity, and health-related quality of life.
Results
Of the 230 participants, study retention was 92%. The 6-month group differences for weight and triglycerides were significant. The intervention group lost 2 pounds more than did the control group (P = .03) and had decreased triglyceride levels (difference in change, 23 mg/dL; P = .02). At 6 months, the intervention group consumed 7.7 fewer grams per day of fat (P = .05) and more fruits and vegetables (P = .02) than did control participants.
Conclusions
Despite challenges designing effective translational interventions for lower-SES and minority communities, this program modestly improved some diabetes risk factors. Thus, individualized, telephone-based models may be a promising alternative to group-based interventions.
doi:10.2105/AJPH.2011.300456
PMCID: PMC3395772  PMID: 22698027
24.  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
25.  High processed meat consumption is a risk factor of type 2 diabetes in the ATBC study 
The British journal of nutrition  2010;103(12):1817-1822.
Relatively small lifestyle modifications related to weight reduction, physical activity and diet has been shown to decrease the risk of type 2 diabetes. Connected with diet, low consumption of meat has been suggested as a protective factor of diabetes. The aim was to examine the association between the consumption of total meat or the specific types of meat and risk of type 2 diabetes. The ATBC cohort included middle aged male smokers. During up to 12 years of follow-up, 1098 incident cases of diabetes were diagnosed from 24,845 participants through the nationwide register. Food consumption was assessed by a validated food frequency questionnaire. In the age and intervention group adjusted model, high total meat consumption was a risk factor of type 2 diabetes (relative risk (RR) 1.50, 95% confidence interval (CI): 1.23, 1.82, highest vs. lowest quintile). The result was similar after adjustment for environmental factors and foods related to diabetes and meat consumption. The RR of type 2 diabetes was 1.37 for processed meat (95% CI: 1.11, 1.71) in the multivariate model. The results were explained more by intakes of sodium than intakes of saturated fatty acids, protein, cholesterol, heme iron, magnesium and nitrate, and were not modified by obesity. No association was found between red meat, poultry and the risk of type 2 diabetes. In conclusion, it may help to prevent the global epidemic of type 2 diabetes by reducing the consumption of processed meat. It seems that sodium of processed meat may explain the association.
doi:10.1017/S0007114510000073
PMCID: PMC3496924  PMID: 20187985
cohort study; epidemiology; meat; processed meat; diabetes

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