Dataset Information

The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial.

ABSTRACT: OBJECTIVE:This study tests the effectiveness of expert guidelines for diabetes prevention: lifestyle intervention with addition of metformin, when required, among people with prediabetes. RESEARCH DESIGN AND METHODS:The Diabetes Community Lifestyle Improvement Program (D-CLIP) is a randomized, controlled, translation trial of 578 overweight/obese Asian Indian adults with isolated impaired glucose tolerance (iIGT), isolated impaired fasting glucose (iIFG), or IFG+IGT in Chennai, India. Eligible individuals were identified through community-based recruitment and randomized to standard lifestyle advice (control) or a 6-month, culturally tailored, U.S. Diabetes Prevention Program-based lifestyle curriculum plus stepwise addition of metformin (500 mg, twice daily) for participants at highest risk of conversion to diabetes at ?4 months of follow-up. The primary outcome, diabetes incidence, was assessed biannually and compared across study arms using an intention-to-treat analysis. RESULTS:During 3 years of follow-up, 34.9% of control and 25.7% of intervention participants developed diabetes (P = 0.014); the relative risk reduction (RRR) was 32% (95% CI 7-50), and the number needed to treat to prevent one case of diabetes was 9.8. The RRR varied by prediabetes type (IFG+IGT, 36%; iIGT, 31%; iIFG, 12%; P = 0.77) and was stronger in participants 50 years or older, male, or obese. Most participants (72.0%) required metformin in addition to lifestyle, although there was variability by prediabetes type (iIFG, 76.5%; IFG+IGT, 83.0%; iIGT, 51.3%). CONCLUSIONS:Stepwise diabetes prevention in people with prediabetes can effectively reduce diabetes incidence by a third in community settings; however, people with iIFG may require different interventions.

SUBMITTER: Weber MB

PROVIDER: S-EPMC5033082 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial.

Weber Mary Beth MB Ranjani Harish H Staimez Lisa R LR Anjana Ranjit M RM Ali Mohammed K MK Narayan K M Venkat KM Mohan Viswanathan V

Diabetes care 20160808 10

<h4>Objective</h4>This study tests the effectiveness of expert guidelines for diabetes prevention: lifestyle intervention with addition of metformin, when required, among people with prediabetes.<h4>Research design and methods</h4>The Diabetes Community Lifestyle Improvement Program (D-CLIP) is a randomized, controlled, translation trial of 578 overweight/obese Asian Indian adults with isolated impaired glucose tolerance (iIGT), isolated impaired fasting glucose (iIFG), or IFG+IGT in Chennai, In ...[more]

PMID: 27504014

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Project description:BackgroundCardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care.MethodsA randomized controlled trial in a primary care setting in which 1934 participants aged 45-70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (- 2.26 mmHg; 95% CI - 4.01: - 0.51) and total cholesterol (- 0.15 mmol/l; 95% CI - 0.23: - 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective.ResultsAfter 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (- 0.0154; 95% CI - 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention.ConclusionsImplementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended.Trial registrationDutch Trial Register NTR4277 , registered on 26 November 2013.

Project description:IntroductionHispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation.MethodsWe recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm.ResultsThe immediate intervention group (-0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (-37.5%, P = .04) compared with the delayed intervention group (-0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group.ConclusionThis home-based intervention delivered by CHWs was associated with a clinically and statistically significant reduction in HbA1c levels in Hispanic adults with HbA1c levels higher than 6%.

Project description:BackgroundIt has been suggested that family history information may be effective in motivating people to adopt health promoting behaviour. The aim was to determine if diabetic familial risk information by using a web-based tool leads to improved self-reported risk-reducing behaviour among individuals with a diabetic family history, without causing false reassurance among those without a family history.MethodsAn online sample of 1,174 healthy adults aged 35-65 years with a BMI ≥ 25 was randomized into two groups receiving an online diabetes risk assessment. Both arms received general tailored diabetes prevention information, whilst the intervention arm also received familial risk information after completing a detailed family history questionnaire. Separate analysis was performed for four groups (family history group: 286 control versus 288 intervention group; no family history: 269 control versus 266 intervention group). Primary outcomes were self-reported behavioural outcomes: fat intake, physical activity, and attitudes towards diabetes testing. Secondary outcomes were illness and risk perceptions.ResultsFor individuals at familial risk there was no overall intervention effect on risk-reducing behaviour after three months, except for a decrease in self-reported saturated fat intake among low-educated individuals (Beta (b) -1.01, 95% CI -2.01 to 0.00). Familial risk information resulted in a decrease of diabetes risk worries (b -0.21, -0.40 to -0.03). For individuals without family history no effect was found on risk-reducing behaviour and perceived risk. A detailed family history assessment resulted in a greater percentage of individuals reporting a familial risk for diabetes compared to a simple enquiry.ConclusionsWeb-based familial risk information reduced worry related to diabetes risk and decreased saturated fat intake of those at greatest need of preventative care. However, the intervention was not effective for the total study population on improving risk-reducing behaviour. The emphasis on familial risk does not seem to result in false reassurance among individuals without family history. Additionally, a detailed family history questionnaire identifies more individuals at familial risk than a simple enquiry.Trial registrationNTR1938.

Project description:BackgroundPrediabetes is an asymptomatic condition in which patients' blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus (T2DM). A key window of opportunity to increase engagement of patients with prediabetes in strategies to prevent T2DM is when they are screened for T2DM and found to have prediabetes, yet the effects of this screening and brief counseling are unknown.MethodsIn this parallel-design randomized controlled trial we will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center (AAVA) who have one or major risk factors for T2DM and an upcoming primary care appointment at the AAVA, but have not had a hemoglobin A1c (HbA1c) test to screen for T2DM in the previous 12 months. After informed consent, participants will complete a baseline survey and be randomly assigned to, at the time of their next primary care appointment, one of two arms: (1) to have a hemoglobin A1c (HbA1c) test to screen for T2DM and receive brief, standardized counseling about these results or (2) to review a brochure about clinical preventive services. Participants will complete surveys 2 weeks, 3 months, and 12 months after their primary care appointment, and a weight measurement 12 months after their primary care appointment. The primary outcome is weight change after 12 months. The secondary outcomes are changes in perception of risk for T2DM; knowledge of T2DM prevention; self-efficacy and motivation to prevent T2DM; use of pharmacotherapy for T2DM prevention; physical activity; participation in weight management programs; and mental health. Quantitative analyses will compare outcomes among participants in the HbA1c test arm found to have prediabetes with participants in the brochure arm. Among participants in the HbA1c test arm found to have prediabetes we will conduct semi-structured interviews about their understanding of and reactions to receiving a prediabetes diagnosis.DiscussionThis trial will generate foundational data on the effects of a prediabetes diagnosis and brief counseling on patients' preventive behaviors and mediators of these behaviors that will enable the development of novel strategies to improve patient engagement in T2DM prevention.Trial registrationClinicalTrials.gov, NCT02747108 . Registered on 18 April 2016.

Project description:BackgroundThe Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC's diabetes prevention program (DPP).ObjectiveThis study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care.MethodsAdults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c levels.ResultsA total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants' weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by -2.64 kg (SE 0.71; P<.001) and -0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c levels.ConclusionsThis novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions.Trial registrationClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342.

Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.

Dataset Information

The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial.

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The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial.

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