Lifestyle Intervention In Primary Care Research Articles

Relationship between Cardiometabolic Factors and the Response of Blood Pressure to a One-Year Primary Care Lifestyle Intervention in Metabolic Syndrome Patients.

Systemic hypertension has been recognized as a modifiable traditional cardiovascular risk factor and influenced by many factors such as eating habits, physical activity, diabetes, and obesity. The objective of this cross-sectional study was to identify factors that predict changes in blood pressure induced by a one-year lifestyle intervention in primary care settings involving a collaboration between family physicians, dietitians, and exercise specialists. Patients with metabolic syndrome diagnosis were recruited by family physicians participating in primary care lifestyle intervention among several family care clinics across Canada. Participants for whom all cardiometabolic data at the beginning (T0) and the end (T12) of the one-year intervention were available were included in the present analysis (n = 101). Patients visited the dietitian and the exercise specialist weekly for the first three months and monthly for the last nine months. Diet quality, exercise capacity, anthropometric indicators, and cardiometabolic variables were evaluated at T0 and at T12. The intervention induced a statistically significant decrease in waist circumference (WC), systolic (SBP) and diastolic (DBP) blood pressure, and plasma triglycerides, and an increase in cardiorespiratory fitness (estimated VO2max). Body weight (p < 0.001), body mass index (BMI) (p < 0.001), and fasting blood glucose (p = 0.006) reduction, and VO2max increase (p = 0.048) were all related to changes in SBP. WC was the only variable for which changes were significantly correlated with those in both SBP (p < 0.0001) and DBP (p = 0.0004). Variations in DBP were not associated with changes in other cardiometabolic variables to a statistically significant extent. Twelve participants were identified as adverse responders (AR) in both SBP and DBP and displayed less favorable changes in WC. The beneficial effects of the primary care lifestyle intervention on blood pressure were significantly associated with cardiometabolic variables, especially WC. These findings suggest that a structured lifestyle intervention in primary care can help improve cardiometabolic risk factors in patients with metabolic syndrome and that WC should be systematically measured to better stratify the patient’s hypertension risk.

Use of lifestyle interventions in primary care for individuals with newly diagnosed hypertension, hyperlipidaemia or obesity: a retrospective cohort study.

Lifestyle interventions can be efficacious in reducing cardiovascular disease risk factors and are recommended as first-line interventions in England. However, recent information on the use of these interventions in primary care is lacking. We investigated for how many patients with newly diagnosed hypertension, hyperlipidaemia or obesity, lifestyle interventions were recorded in their primary care electronic health record. A retrospective cohort study. English primary care, using UK Clinical Practice Research Datalink. A total of 770,711 patients who were aged 18 years or older and received a new diagnosis of hypertension, hyperlipidaemia or obesity between 2010 and 2019. Record of lifestyle intervention and/or medication in 12 months before to 12 months after initial diagnosis (2-year timeframe). Analyses show varying results across conditions: While 55.6% (95% CI 54.9-56.4) of individuals with an initial diagnosis of hypertension were recorded as having lifestyle support (lifestyle intervention or signposting) within the 2-year timeframe, this number was reduced to 45.2% (95% CI 43.8-46.6) for hyperlipidaemia and 52.6% (95% CI 51.1-54.1) for obesity. For substantial proportions of individuals neither lifestyle support nor medication (hypertension: 12.2%, 95% CI 11.9-12.5; hyperlipidaemia: 32.2%, 95% CI 31.2-33.3; obesity: 43.9%, 95% CI 42.3-45.4) were recorded. Sensitivity analyses confirm that limited proportions of patients had lifestyle support recorded in their electronic health record before they were first prescribed medication (diagnosed and undiagnosed), ranging from 12.1% for hypertension to 19.7% for hyperlipidaemia, and 19.5% for obesity (23.4% if restricted to Orlistat). Limited evidence of lifestyle support for individuals with cardiovascular risk factors (hypertension, hyperlipidaemia, obesity) recommended by national guidelines in England may stem from poor recording in electronic health records but may also represent missed opportunities. Given the link between progression to cardiovascular disease and modifiable lifestyle factors, early support for patients to manage their conditions through non-pharmaceutical interventions by establishing lifestyle modification as first-line treatment is crucial.

GPs’ views on the implementation of combined lifestyle interventions in primary care in the Netherlands: a qualitative study

ObjectivesPrevention and lifestyle support are emerging topics in general practice. Healthcare insurance companies reimburse combined lifestyle interventions (CLIs) in the Netherlands since January 2019. CLIs support people with overweight (body...

"My Patients Asked Me If I Owned a Fruit Stand in Town or Something." Barriers and Facilitators of Personalized Dietary Advice Implemented in a Primary Care Setting.

Primary care is especially well positioned to address prevention of non-communicable diseases. However, implementation of health promotion activities such as personalized dietary advice is challenging. The study aim was to understand barriers and facilitators of the personalized dietary advice component of a lifestyle intervention in primary care, as perceived by health center professionals and program participants. Thirteen focus groups were conducted with 49 professionals and 47 participants. Audio recordings were transcribed. Professional group text was coded using the Consolidated Framework for Implementation Research (CFIR). Participant group text was coded via an inductive approach with thematic analysis. Across most CFIR domains, both barriers and facilitators were equally present, except for ‘characteristics of individuals’, which were primarily facilitators. Intervention characteristics was the most important domain, with barriers in design and packaging (e.g., the ICT tool) and complexity. Facilitators included high evidence strength and quality, adaptability, and relative advantage. Participants described the importance of more personalized advice, the value of follow-up with feedback, and the need to see outcomes. Both professionals and patients stated that primary care was the place for personalized dietary advice intervention, but that lack of time, workload, and training were barriers to effective implementation. Implementation strategies targeting these modifiable barriers could potentially increase intervention adoption and intervention effectiveness.

849-P: Comparative Effectiveness of In-Person and Conference Call Group Lifestyle Interventions in Primary Care—The Real Health Diabetes Randomized Clinical Trial (RCT)

Background: Lifestyle interventions (LI) to treat obesity and type 2 diabetes improve medical outcomes but are not currently available in usual care. Objective: To compare the effectiveness of 2 LI programs: in-person group (IP) and telephone conference call (TCC) to medical nutrition therapy (MNT), on weight loss at 1 year in a practice-based RCT. The LI programs are adapted from Look AHEAD’s LI program and delivered in 3 community health centers and one hospital-based practice. Methods: Patients with type 2 diabetes, HbA1c 6.5-11.5, BMI &amp;gt; 25 (&amp;gt; 23 in Asians) kg/m2 (n=211) were randomly assigned to IP (n=70), TCC (n=72), or MNT (n=69). Trained registered dietitians delivered 25 lifestyle sessions in the first year. MNT participants had facilitated referral for outpatient dietitian visits (usual care). Results: Participants were 62 ± 10 years, 45% male, 77% white, with BMI 35 ± 6 kg/m2, diabetes duration 10 ± 8 years and HbA1c 7.7 ± 1.2%; 66% of IP and 72% of TCC attended &amp;gt;18/25 sessions. Mean percent weight change at 6 and 12 months was -5.6 ± 4.9 and -4.6 ± 6.1 in IP, -4.6 ± 5.8 and -4.8 ± 6.1 in TCC, and -1.1 ± 3.7 and -2.0 ± 4.1 in MNT, with statistically significant differences between both LI arms and MNT (P&amp;lt;0.01 at both timepoints), but not between the two LI arms at 6 and 12 months. HbA1c improved in all participants with no statistically significant differences among study arms. At 6 and 12 months, 42 and 45% of IP participants had stopped or reduced a glucose-lowering medication, compared to 23% of MNT participants at both timepoints (P=0.03 and 0.01, respectively). No significant difference in medication reduction was observed between TCC participants (33 and 36% at 6 and 12 months) and the other two groups. Conclusions: IP and TCC lifestyle interventions can achieve equivalent outcomes in terms of clinically significant weight loss, improvement in glycemic control, and participant engagement. The TCC delivery format may extend program reach. Disclosure L.M. Delahanty: Advisory Panel; Self; Jana Care Inc., Omada Health, Inc., Weight Watchers International, Inc. Y. Chang: None. B.C. Porneala: None. J. McCarthy: None. V.M. Goldman: None. D.E. Levy: None. D.J. Wexler: Other Relationship; Spouse/Partner; APOLO1BIO. Funding National Institute of Diabetes and Digestive and Kidney Diseases

Implementation of the DP-Transfers Project in Catalonia—A Translational Method to Improve Diabetes Screening and Prevention in Primary Care

Background: DP-TRANSFERS(Diabetes Prevention-Transferring findings from European research to society) is a large scale national program aimed at translating a lifestyle diabetes prevention intervention (DE-PLAN-CAT) in primary care centers in Catalonia. Methods: Multidisciplinary committee evaluated the programme. Participants without diabetes aged 45-75 years (FINDRISC&amp;gt;11 and/or prediabetes) were posible candidates. Implementation was a 4-channel transfer approach (institutional relationships, facilitator WS, collaborative groupware, programme website) and built upon a 3-step (screening, intervention, follow-up) real-life strategy. The 2-year lifestyle intervention program included an initial 9-hour and 15-hour continuity module, 6 and 10 sessions respectively. A 3-level (centre, professionals and participants) descriptive analysis was conducted using cluster sampling by contributing centres to assess results and barriers identified one year after implementation. Results: Between June2016 and July2017, 103 PHCC 1.4 million inhabitants (27.9% of all centres), 5professionals agreed to participate. After 1 year,83 centres (80.6%) remained active and 3professionals (60.3%) were involved. Implementation was not feasible in 20 centres (19.4%) 5 main barriers: lack of staff support; discontinuity of the initial effort; increase of workload; shift in professional status and lack of acceptance. Overall, 1819 people were screened and 1458 (80.1%) followed the lifestyle intervention, with 1190 (81.6% or 65.4% of those screened) participating in the basic module and 912 in the continuity (62.5% or 50.1%, respectively). Conclusions: Large-scale lifestyle intervention in primary care can be properly implemented using existing public health resources. Regrettably, one fifth of the centres and more than one third of the professionals showed substantial resistance to performing these additional activities. Disclosure B. Costa: None. S. Mestre: None. F. Barrio: None. J. Cabre: None. F. Cos: Speaker's Bureau; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Novo Nordisk Inc.. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Sanofi Pasteur. Speaker's Bureau; Self; Sanofi Pasteur. Advisory Panel; Self; Sanofi-Aventis. Speaker's Bureau; Self; Sanofi-Aventis. Research Support; Self; Eli Lilly and Company. S. Aguilar: None. C. Sole: None. C. Castell: None. V. Arija: None. J. Lindstrom: None.

Implementation of the DP-TRANSFERS project in Catalonia: A translational method to improve diabetes screening and prevention in primary care.

BackgroundThe DE-PLAN-CAT project (Diabetes in Europe–Prevention using lifestyle, physical activity and nutritional intervention–Catalonia) has shown that an intensive lifestyle intervention is feasible in the primary care setting and substantially reduces the incidence of diabetes among high-risk Mediterranean participants. The DP-TRANSFERS project (Diabetes Prevention–Transferring findings from European research to society) is a large-scale national programme aimed at implementing this intervention in primary care centres whenever feasible.MethodsA multidisciplinary committee first evaluated the programme in health professionals and then participants without diabetes aged 45–75 years identified as being at risk of developing diabetes: FINDRISC (Finnish Diabetes Risk Score)>11 and/or pre-diabetes diagnosis. Implementation was supported by a 4-channel transfer approach (institutional relationships, facilitator workshops, collaborative groupware, programme website) and built upon a 3-step (screening, intervention, follow-up) real-life strategy. The 2-year lifestyle intervention included a 9-hour basic module (6 sessions) and a subsequent 15-hour continuity module (10 sessions) delivered by trained primary healthcare professionals. A 3-level (centre, professionals and participants) descriptive analysis was conducted using cluster sampling to assess results and barriers identified one year after implementation.ResultsThe programme was started in June-2016 and evaluated in July-2017. In all, 103 centres covering all the primary care services for 1.4 million inhabitants (27.9% of all centres in Catalonia) and 506 professionals agreed to develop the programme. At the end of the first year, 83 centres (80.6%) remained active and 305 professionals (60.3%) maintained regular web-based activities. Implementation was not feasible in 20 centres (19.4%), and 5 main barriers were prioritized: lack of healthcare manager commitment; discontinuity of the initial effort; substantial increase in staff workload; shift in professional status and lack of acceptance. Overall, 1819 people were screened and 1458 (80.1%) followed the lifestyle intervention, with 1190 (81.6% or 65.4% of those screened) participating in the basic module and 912 in the continuity module (62.5% or 50.1%, respectively).ConclusionsA large-scale lifestyle intervention in primary care can be properly implemented within a reasonably short time using existing public healthcare resources. Regrettably, one fifth of the centres and more than one third of the professionals showed substantial resistance to performing these additional activities.

Effectiveness of a targeted lifestyle intervention in primary care on diet and physical activity among South Asians at risk for diabetes: 2-year results of a randomised controlled trial in the Netherlands

ObjectivesIn South Asian populations, little is known about the effects of intensive interventions to reduce the risk of type 2 diabetes on health behaviour. We examined the effectiveness at 2...

Cost analysis of a peer support programme for patients with type 2 diabetes: a secondary analysis of a controlled trial.

This study aimed to explore if group-based peer support as an additional component to a disease management programme (DMP) in type 2 diabetes can reduce the number of prescribed drugs; hospital admissions; and length of hospital stay and therefore be a cost-effective model. Controlled study based on a secondary data analysis of a cluster randomized trial. Our study population was general practitioners and patients in the province of Salzburg. The 24-months intervention consisted of regular group meetings facilitated by trained peer supporters. The groups exercised together, discussed diabetes related topics, and received support by professionals. Data was anonymously collected on clusters through the statutory health insurance. Data were available of 118 (82.5%,17 clusters of the patients in the original randomized trial) participants in the intervention and 143 (77.3%,19 clusters) in the control groups. The length of hospital stay was shorter in the intervention groups compared with controls. The mean difference during the 24-month study period was -40.13 days (95% CI - 78.54 to - 1.71, P = 0.041) in favour of the intervention groups. No differences were seen in the number of prescribed drugs and hospital admission. Estimated yearly savings by reducing the length of hospital stay was €1660.60 per patient. A group-based peer support programme as an additional component of a DMP in type 2 diabetes is a promising approach to optimize diabetes care and to enhance lifestyle interventions in primary care. Peer support seems to reduce length of hospital stay and could therefore be a cost-effective model.

A lifestyle intervention in primary care prevents deterioration of insulin resistance in patients with impaired glucose tolerance: A randomised controlled trial.

We hypothesised that the expected increase in insulin resistance over three years' time in individuals with impaired glucose tolerance (IGT) and/or impaired fasting glucose could be attenuated by an intervention with focus on physical activity in ordinary primary care. We conducted a randomised controlled trial with 96 participants over three years. Examination of the participants included anthropometric measures, blood pressure, body weight and height, blood samples, an oral glucose tolerance test, and questionnaires about diet and lifestyle. The study subjects were randomised to either an intense intervention with information, group sessions, referral to physical activity and a step-counter ( n = 31), a less intense intervention without the group sessions ( n = 35), or care as usual group (CAUG) ( n = 30). Differences between the groups were analysed with general linear models adjusted for age, gender, baseline values and time in the intervention. Individual insulin resistance increased in the CAUG. Due to having a similar effect, we combined the two intervention groups into a combined intervention group (CIG; n = 66) in the analyses. In individuals with IGT, the increase in the homeostatic model assessment-insulin resistance differed significantly between those in the CAUG and the CIG (Δ = 0.8; CI: 0.1-1.6; p = 0.034). Likewise, diastolic blood pressure decreased more in the CIG than in the CAUG (Δ = 5.1; CI: 0.1-10.0; p = 0.047). A total of 17 individuals developed Type 2 diabetes, 23% were in the CIG and 33% in the CAUG; so there was a 32% reduced risk in the intervention group. A lifestyle intervention focused on physical activity is feasible in ordinary primary care and prevents deterioration in insulin sensitivity in individuals with IGT over a three-year period.

The implementation and sustainability of a combined lifestyle intervention in primary care: mixed method process evaluation.

BackgroundThe impact of physical inactivity and unhealthy diet on health is increasingly profound. Lifestyle interventions targeting both behaviors simultaneously might decrease the prevalence of overweight and comorbidities. The Dutch ‘BeweegKuur’ is a combined lifestyle intervention (CLI) in primary care, to improve physical activity and dietary behavior in overweight people. In a cluster randomized controlled trial, the (cost-) effectiveness of an intensively guided program has been compared to a less intensively guided program. This process evaluation aimed to assess protocol adherence and potential differences between clusters. In addition, sustainability (i.e. continuation of the CLI in practice after study termination) was evaluated.MethodsExisting frameworks were combined to design the process evaluation for our intervention and setting specifically. We assessed reach, fidelity, dose delivered and received, context and implementation strategy. Both qualitative and quantitative data were used for a comprehensive evaluation. Data were collected in semi-structured interviews with health care providers (HCPs, n = 25), drop-out registration by HCPs, regular questionnaires among participants (n = 411) and logbooks kept by researchers during the trial.ResultsProtocol adherence by professionals and participants varied between the programs and clusters. In both programs the number of meetings with all HCPs was lower than planned in the protocol. Participants of the supervised program attended, compared to participants of the start-up program, more meetings with physiotherapists, but fewer with lifestyle advisors and dieticians. The ‘BeweegKuur’ was not sustained, but intervention aspects, networks and experiences were still utilized after finalization of the project. Whether clusters continued to offer a CLI seemed dependent on funding opportunities and collaborations.ConclusionsProtocol adherence in a CLI was problematic in both HCPs and participants. Mainly the amount of dietary guidance was lower than planned, and decreased with increasing guidance by PT. Thus, feasibility of changing physical activity and dietary habits simultaneously by one intervention in one year was not as high as expected. Also the sustainability of CLI was poor. When a CLI program is started, re-invention should be allowed and maximum effort should be taken to guarantee long term continuation, by planning both implementation and sustainability carefully.Trial registrationCurrent Controlled Trials ISRCTN46574304. Registered 23 December 2010.

Exploring the process when developing a lifestyle intervention in primary care for type 2 diabetes: a longitudinal process evaluation

ObjectivesA thorough understanding of the processes involved in lifestyle interventions is needed in order to close the gap between research and daily practice. This study explored the processes involved in the provision of a lifestyle intervention to patients with type 2 diabetes mellitus (T2DM) by health care professionals in primary care. Study designMixed methods. MethodsHealth care professionals were asked to intensify lifestyle interventions for patients with T2DM in a routine care setting. Data were collected by serial interviews with health care professionals and patients, recorded consultations, an activity questionnaire and biomedical information. Qualitative data were analysed using a framework analysis with a phenomenological approach. ResultsThe lifestyle intervention developed by the health care professionals included motivational interviewing, a nutrition and physical activity diary, and a multidisciplinary approach [physiotherapist, dietician, general practitioner and diabetes practice nurse (DPN)]. Participants and health care professionals were positive about the intervention, and patients were more active (P = 0.027), lost weight (P = 0.031) and had lower levels of glycated haemoglobin (P = 0.012). However, qualitative data showed that patients were passive during the consultation, and did not ask questions about ways to improve their lifestyle. DPNs did not use motivational interviewing optimally; provided patients with information that was difficult to understand; and were easily satisfied with the efforts of the patients. ConclusionsLifestyle intervention for patients with T2DM is difficult in routine primary care. DPNs should adapt to the knowledge level of the patients, and patients must be stimulated to take an active role in their treatment. Patients and health care professionals should become equal partners in determining mutually agreeable treatment plans and goals.

Contextualizing the Effectiveness of a Lifestyle Intervention in Primary Care: A Qualitative Assessment

The Healthy Eating and Active Living for Diabetes (HEALD) proved effective in increasing physical activity among type 2 diabetes patients in 4 community-based Primary Care Networks (PCNs) in Alberta. We contextualize its effectiveness by describing implementation fidelity and PCN staff's perceptions of effectiveness.

Economic evaluation of a lifestyle intervention in primary care to prevent type 2 diabetes mellitus and cardiovascular diseases: a randomized controlled trial

BackgroundCost-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.MethodsAdults 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.ResultsSmall, 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.ConclusionA 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 registrationCurrent Controlled Trials ISRCTN59358434.

Implementation of a lifestyle intervention for type 2 diabetes prevention in Dutch primary care: opportunities for intervention delivery

BackgroundAs 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.MethodsA 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.ResultsDrop-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.ConclusionsHigh 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.

Process Evaluation of a Lifestyle Intervention in Primary Care

The Groningen Overweight and Lifestyle (GOAL) intervention effectively prevents weight gain. The present study describes a process evaluation in which 214 participants in the intervention group received a structured questionnaire within 7 months (a median of 5 months) after the end of the intervention. The authors investigated the content of the intervention (on basis of the participants' recall), the participants' satisfaction of the intervention, the participants' satisfaction with the nurse practitioners (NPs), and the determinants of the participants' satisfaction. In general, the results show that the content corresponded well with the protocol for the intervention, except for the number of telephone calls and the percentage of participants with individualized goals for a healthy lifestyle. The overall satisfaction of the participants was high, and success and perceived success and a low educational level were important determinants for a higher overall satisfaction grade. Furthermore, the NP was considered to be an expert and motivational to learning and keeping up a healthy lifestyle. The authors therefore conclude that the GOAL study is feasible and indicates that the NP is well equipped to treat these patients. However, it is recommended to reinforce the advice given and the lifestyle goals after the first contact sessions.

Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial

BackgroundEfficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings.DesignE-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided α level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up.Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined.DiscussionThis study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.Trial registrationNCT00842426

Review finds limited evidence that ‘stages of changeʼ interventions modify behaviour in primary careAbstracted from: van Sluijs EMF, van Poppel MNM, van Mechelen W. Stage-based lifestyle interventions in primary care. Are they effective? Am J Prev Med 2004; 26: 330-43.

Review finds limited evidence that ‘stages of changeʼ interventions modify behaviour in primary careAbstracted from: van Sluijs EMF, van Poppel MNM, van Mechelen W. Stage-based lifestyle interventions in primary care. Are they effective? Am J Prev Med 2004; 26: 330-43.

Stage-based lifestyle interventions in primary careAre they effective?

Background To systematically review the literature concerning the effect of stages-of-change–based interventions in primary care on smoking, physical activity, and dietary behavior. Methods An extensive search (until July 2002) was performed using the following inclusion criteria: (1) (randomized) controlled trial (RCT/CT), (2) intervention initiated in primary care, (3) and intervention aimed at changing smoking, physical activity, or dietary behavior, and stages-of-change-based outcomes, and (4) behavioral outcomes. Methodologic quality was assessed, and conclusions on the effectiveness at short-, medium-, and long-term follow-up were based on a rating system of five levels of evidence. Odds ratios were calculated when methodologically appropriate. Results A total of 29 trials were selected for inclusion. Thirteen studies included a physical activity intervention, 14 aimed at smoking cessation, and five included a dietary intervention. Overall methodologic quality was good. No evidence was found for an effect on stages of change and actual levels of physical activity. Based on the strength of the evidence, limited to no evidence was found for an effect on stages of change for smoking and smoking quit rates. Odds ratios for quitting smoking showed a positive trend. Strong evidence was found for an effect on fat intake at short- and long-term follow-up. Limited evidence was found for an effect on stages of change for fat intake at short-term follow-up. Conclusions The scientific evidence for the effect of stages-of-change–based lifestyle interventions in primary care is limited. Limiting aspects in the stages-of-change concept with respect to complex behaviors as physical activity and dietary behavior are discussed.