Related Articles

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Background

Patient outcomes are poorly affected by lifestyle advice in general practice. Promoting lifestyle behavior change require that nurses shift from simple advice giving to a more counseling-based approach. The current study examines which barriers nurses encounter in lifestyle counseling to patients with type 2 diabetes. Based on this information we will develop an implementation strategy to improve lifestyle behavior change in general practice.

Method

In a qualitative semi-structured study, twelve in-depth interviews took place with nurses in Dutch general practices involved in diabetes care. Specific barriers in counseling patients with type 2 diabetes about diet, physical activity, and smoking cessation were addressed. The nurses were invited to reflect on barriers at the patient and practice levels, but mainly on their own roles as counselors. All interviews were audio-recorded and transcribed. The data were analyzed with the aid of a predetermined framework.

Results

Nurses felt most barriers on the level of the patient; patients had limited knowledge of a healthy lifestyle and limited insight into their own behavior, and they lacked the motivation to modify their lifestyles or the discipline to maintain an improved lifestyle. Furthermore, nurses reported lack of counseling skills and insufficient time as barriers in effective lifestyle counseling.

Conclusions

The traditional health education approach is still predominant in primary care of patients with type 2 diabetes. An implementation strategy based on motivational interviewing can help to overcome 'jumping ahead of the patient' and promotes skills in lifestyle behavioral change. We will train our nurses in agenda setting to structure the consultation based on prioritizing the behavior change and will help them to develop social maps that contain information on local exercise programs.

Background

Error in self-reported measures of obesity has been frequently described, but the effect of self-reported error on recruitment into diabetes prevention programs is not well established. The aim of this study was to examine the effect of using self-reported obesity data from the Finnish diabetes risk score (FINDRISC) on recruitment into the Greater Green Triangle Diabetes Prevention Project (GGT DPP).

Methods

The GGT DPP was a structured group-based lifestyle modification program delivered in primary health care settings in South-Eastern Australia. Between 2004–05, 850 FINDRISC forms were collected during recruitment for the GGT DPP. Eligible individuals, at moderate to high risk of developing diabetes, were invited to undertake baseline tests, including anthropometric measurements performed by specially trained nurses. In addition to errors in calculating total risk scores, accuracy of self-reported data (height, weight, waist circumference (WC) and Body Mass Index (BMI)) from FINDRISCs was compared with baseline data, with impact on participation eligibility presented.

Results

Overall, calculation errors impacted on eligibility in 18 cases (2.1%). Of n = 279 GGT DPP participants with measured data, errors (total score calculation, BMI or WC) in self-report were found in n = 90 (32.3%). These errors were equally likely to result in under- or over-reported risk. Under-reporting was more common in those reporting lower risk scores (Spearman-rho = −0.226, p-value < 0.001). However, underestimation resulted in only 6% of individuals at high risk of diabetes being incorrectly categorised as moderate or low risk of diabetes.

Conclusions

Overall FINDRISC was found to be an effective tool to screen and recruit participants at moderate to high risk of diabetes, accurately categorising levels of overweight and obesity using self-report data. The results could be generalisable to other diabetes prevention programs using screening tools which include self-reported levels of obesity.

OBJECTIVE— The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle and metformin interventions reduced the incidence of type 2 diabetes compared with a placebo intervention. The aim of this study was to assess the cost-effectiveness of the lifestyle and metformin interventions relative to the placebo intervention.

RESEARCH DESIGN AND METHODS— Analyses were performed from a health system perspective that considered direct medical costs only and a societal perspective that considered direct medical costs, direct nonmedical costs, and indirect costs. Analyses were performed with the interventions as implemented in the DPP and as they might be implemented in clinical practice.

RESULTS— The lifestyle and metformin interventions required more resources than the placebo intervention from a health system perspective, and over 3 years they cost approximately $2,250 more per participant. As implemented in the DPP and from a societal perspective, the lifestyle and metformin interventions cost $24,400 and $34,500, respectively, per case of diabetes delayed or prevented and $51,600 and $99,200 per quality-adjusted life-year (QALY) gained. As the interventions might be implemented in routine clinical practice and from a societal perspective, the lifestyle and metformin interventions cost $13,200 and $14,300, respectively, per case of diabetes delayed or prevented and $27,100 and $35,000 per QALY gained. From a health system perspective, costs per case of diabetes delayed or prevented and costs per QALY gained tended to be lower.

CONCLUSIONS— Over 3 years, the lifestyle and metformin interventions were effective and were cost-effective from the perspective of a health system and society. Both interventions are likely to be affordable in routine clinical practice, especially if implemented in a group format and with generic medication pricing.

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.”

Background:

Research on the translation of efficacious lifestyle change programs to prevent type 2 diabetes into community or clinical settings is needed.

Objectives:

To examine the reach, implementation, and efficacy of a 6-month lifestyle program implemented in primary care by nurse practitioners (NP) for adults at risk for type 2 diabetes.

Method:

The NP sites (n = 4) were randomized to an enhanced standard care program (1 NP and 1 nutrition session) or a lifestyle program (enhanced standard care and 6 NP sessions). These NPs recruited adults at-risk for diabetes from their practice (n = 58) with an acceptance rate of 70%.

Results:

The program reached a diverse, obese, moderately low-income sample. The NPs were able to successfully implement the protocols. The average length of the program was 9.3 months. Attendance was high (98%) and attrition low (12%). The NPs were able to adopt the educational, behavioral, and psychosocial strategies of the intervention easily. Motivational interviewing was more difficult for NPs. Mixed-model repeated measures analysis indicated significant trends or improvement in both groups for nutrition and exercise behavior. Participants of the lifestyle program demonstrated trends for better high density lipoprotein (HDL) as well as exercise behavior compared to enhanced standard care participants. Twenty-five percent of lifestyle participants met treatment goals of 5% weight loss compared to 11% of standard care participants.

Discussion:

A lifestyle program can be implemented in primary care by NPs, reach the targeted population, and be modestly successful. Further research is indicated.

Background

Studies have shown that lifestyle behavior changes are most effective to prevent onset of diabetes in high-risk patients. Primary care providers are charged with encouraging behavior change among their patients at risk for diabetes, yet the practice environment and training in primary care often do not support effective provider counseling. The goal of this study is to develop an electronic health record-embedded tool to facilitate shared patient-provider goal setting to promote behavioral change and prevent diabetes.

Methods

The ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial leverages an innovative system that integrates evidence-based interventions for behavioral change with already-existing technology to enhance primary care providers' effectiveness to counsel about lifestyle behavior changes. Using principles of behavior change theory, the multidisciplinary design team utilized in-depth interviews and in vivo usability testing to produce a prototype diabetes prevention counseling system embedded in the electronic health record.

Results

The core element of the tool is a streamlined, shared goal-setting module within the electronic health record system. The team then conducted a series of innovative, "near-live" usability testing simulations to refine the tool and enhance workflow integration. The system also incorporates a pre-encounter survey to elicit patients' behavior-change goals to help tailor patient-provider goal setting during the clinical encounter and to encourage shared decision making. Lastly, the patients interact with a website that collects their longitudinal behavior data and allows them to visualize their progress over time and compare their progress with other study members. The finalized ADAPT system is now being piloted in a small randomized control trial of providers using the system with prediabetes patients over a six-month period.

Conclusions

The ADAPT system combines the influential powers of shared goal setting and feedback, tailoring, modeling, contracting, reminders, and social comparisons to integrate evidence-based behavior-change principles into the electronic health record to maximize provider counseling efficacy during routine primary care clinical encounters. If successful, the ADAPT system may represent an adaptable and scalable technology-enabled behavior-change tool for all primary care providers.

Trial Registration

ClinicalTrials.gov Identifier NCT01473654

Background

Previous interventions to increase physical activity and reduce cardiovascular risk factors have been targeted at individuals with established disease; less attention has been given to intervention among individuals with high risk for disease nor has there been determination of the influence of setting in which the intervention is provided. In particular, family practice represents an ideal setting for the provision and long-term maintenance of lifestyle interventions for patients at risk (ie high-normal blood pressure or impaired glucose tolerance).

Methods/design

The Staged Nutrition and Activity Counseling (SNAC) study is a randomized clustered design clinical trial that will investigate the effectiveness and efficacy of a multi-component lifestyle intervention on cardiovascular disease risk factors and vascular function in patients at risk in primary care. Patients will be randomized by practice to either a standard of care lifestyle intervention or a behaviourally-based, matched prescriptive physical activity and diet change program. The primary goal is to increase physical activity and improve dietary intake according to Canada's Guides to Physical Activity Healthy Eating over 24 months. The primary intention to treat analysis will compare behavioral, physiological and metabolic outcomes at 6, 12 and 24 months post-randomization including estimation of incident hypertension and/or diabetes.

Discussion

The design features of our trial, and the practical problems (and solutions) associated with implementing these design features, particularly those that result in potential delay between recruitment, baseline data collection, randomization, intervention, and assessment will be discussed. Results of the SNAC trial will provide scientific rationale for the implementation of this lifestyle intervention in primary care.

Trial registration

ISRCTN: ISRCTN:42921300

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.

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

Background

Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours.

Methods/Design

This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse) from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted.

Discussion

Opportunistic engagement by health professionals potentially represents a cost effective medical intervention. This study integrates an existing, innovative intervention method with an innovative training model to enable clinicians to routinely use BCC, providing them with new tools to encourage and support people to make healthier choices. This trial will evaluate effectiveness in primary care and determine costs of the intervention.

Trial Registration

ISRCTN22495456

Background

Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach.

The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects.

Methods

For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards.

Results

Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics between the study arms.

Conclusion

We have launched J-DOIT1, a nation-wide trial to prevent the development of T2DM in high-risk individuals using telephone-delivered intervention. This trial is expected to contribute to evidence-based real-world preventive practices.

Trial registration

UMIN000000662.

Background

Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus). Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. A Cochrane review highlighted as priority, the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease.

Methods

A single blind randomised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack (TIA) and stroke in effecting a positive change in the primary outcome measures of cardiac risk scores derived from Blood Pressure, lipid profile, smoking and diabetic status and lifestyle factors of habitual smoking, exercise and healthy eating participation. Secondary outcomes of interest include health related quality of life as measured by the Hospital Anxiety and Depression Scale, the Stroke Specific Quality of Life scale and WONCA COOP Functional Health Status charts and cardiovascular fitness as measured by a sub-maximal fitness test.

A total of 144 patients, over 18 years of age with confirmed diagnosis of ischaemic stroke or TIA, will be recruited from Dublin community stroke services and two tertiary T.I.A clinics. Exclusion criteria will include oxygen dependence, unstable cardiac conditions, uncontrolled diabetes, major medical conditions, claudication, febrile illness, pregnancy or cognitive impairment. Participants will be block-statified, randomly allocated to one of two groups using a pre-prepared computer generated randomisation schedule. Both groups will receive a two hour education class on risk reduction post stroke. The intervention group will receive a 10 week programme of supervised aerobic exercises (twice weekly) and individually tailored brief intervention lifestyle counselling. Both groups will be tested on week one and week ten of the programme. Follow-up at 1 year will assess longer term benefits. Analysis will test for significant changes in the key variables indicated.

Discussion

Application of the Cardiac Rehabilitation paradigm to patients with ischaemic stroke or TIA has not been explored despite the obvious overlap in aetiology. It is hoped the anticipated improvement in vascular risk factors and fitness resulting from such a programme will enhance health and social gain in this population.

Trial Registration

Current Controlled Trials ISCTRN90272638.