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One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial.

ABSTRACT: AIMS:To estimate the real-world effects of offering a group-based lifestyle intervention (GLI) to adults with diabetes. METHODS:This randomized encouragement trial included adult primary care patients in metropolitan Chicago with type 2 diabetes and body mass index ?24?kg/m2. Participants were randomized to standard care (brief dietary and lifestyle counseling) or standard care plus being encouraged, but not required, to participate in a free-of-charge GLI offered by the YMCA. The GLI was a group-based adaptation of the Look AHEAD lifestyle intervention. RESULTS:Of 331 participants, 167 were randomized to standard care and 164 to the GLI encouragement arm. About one third of participants were non-Hispanic White (34.4%). In the GLI arm, 75 (45.7%) attended ?1 GLI visits. In the primary intention-to-treat analysis, the effect of GLI encouragement was 0.95% weight loss at six months (95% confidence interval [CI], 0.13-1.77%; P?=?0.02), and 1.20% weight loss at 12?months (95% CI, 0.05-2.36%; P?=?0.04). At 12?months, there was a 0.30% (3.3?mmol/mol) reduction in hemoglobin A1c, but this result did not achieve statistical significance (P?=?0.054). In instrumental variable analysis estimating effects among the subgroup of participants who attended any GLI visits, the effect of GLI attendance was 2.30% weight loss at six months (95% CI, 0.30-4.30%; P?=?0.02), and 2.07% weight loss at 12?months (95% CI, 0.25-3.88%; P?=?0.02). We detected no significant blood pressure or cholesterol effects. CONCLUSIONS:Among adults with type 2 diabetes, a group-based lifestyle intervention in a community-based setting achieved modest weight loss at 6 and 12?months. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT01435603.

SUBMITTER: Liss DT

PROVIDER: S-EPMC5990453 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial.

Liss David T DT Finch Emily A EA Cooper Andrew A Sheth Avani A Tejuosho Ashantí D AD Lancki Nicola N Ackermann Ronald T RT

Diabetes research and clinical practice 20180327

<h4>Aims</h4>To estimate the real-world effects of offering a group-based lifestyle intervention (GLI) to adults with diabetes.<h4>Methods</h4>This randomized encouragement trial included adult primary care patients in metropolitan Chicago with type 2 diabetes and body mass index ≥24 kg/m<sup>2</sup>. Participants were randomized to standard care (brief dietary and lifestyle counseling) or standard care plus being encouraged, but not required, to participate in a free-of-charge GLI offered by th ...[more]

PMID: 29596950

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Project description:IMPORTANCE:Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). OBJECTIVE:To compare the remission of T2DM following surgical and nonsurgical treatments. DESIGN, SETTING, AND PARTICIPANTS:In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population. INTERVENTIONS:Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. MAIN OUTCOMES AND MEASURES:Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change. RESULTS:Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n?=?8) of RYGB, 29% (n?=?6) of LAGB, and no intensive lifestyle weight loss intervention participants (P?=?.004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P?<?.001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P?<?.01). CONCLUSIONS AND RELEVANCE:Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01047735.

Project description:BackgroundIn this study, we tested the efficacy of a low-intensity lifestyle intervention aimed at reducing the risk of cardiovascular disease among mid-life individuals.MethodsWe conducted a randomized controlled trial in which participants were randomly assigned either to receive a health report card with counselling (from a Telehealth nurse) on smoking, exercise, nutrition and stress or to receive usual care. The patients were divided into 2 groups on the basis of risk: the primary prevention group, with a Framingham risk score of 10% or higher (intervention, n = 157; control, n = 158), and the secondary prevention group, who had a diagnosis of coronary artery disease (intervention, n = 153; control, n = 143). The primary outcome was a change in the Framingham global risk score between baseline and 1-year follow-up. Data were analyzed separately for the 2 prevention groups using an intention-to-treat analysis controlling for covariates.ResultsWithin the primary prevention group, there were statistically significant changes for the treatment group relative to the controls, from baseline to year 1, in Framingham score (intervention, -3.10 [95% confidence interval (CI) -3.98 to -2.22]; control, -1.30 [95% CI -2.18 to -0.42]; p < 0.01) and scores for total cholesterol (intervention, -0.41 [95% CI -0.59 to -0.23]; control, -0.14 [95% CI -0.32 to 0.04]; p < 0.05), systolic blood pressure (intervention, -7.49 [95% CI -9.97 to -5.01]; control, -3.58 [95% CI -6.08 to -1.08]; p < 0.05), nutrition level (intervention, 0.30 [95% CI 0.13 to 0.47]; control, -0.05 [95% CI -0.22 to 0.12]; p < 0.01), and health confidence (intervention, 0.20 [95% CI 0.09 to 0.31]; control, 0.04 [95% CI -0.07 to 0.15]; p < 0.05), with adjustment for covariates. No significant changes in outcome variables were found for the secondary prevention group.InterpretationWe found evidence for the efficacy of an intervention addressing multiple risk factors for primary prevention at 1 year using Framingham risk score report cards and telephone counselling. (Requirement for clinical trial registration waived [enrolment completed before requirement became applicable].).

Project description:BackgroundAfrican Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics.Research design and methodsThis randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms.ResultsAt 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = - 0.026, p = 0.003) and the comparison arm (β = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months.ConclusionsThe LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.Nih trial registry numberNCT01901952.

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One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial.

Publications

One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial.

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