Dataset Information

Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial.

ABSTRACT: OBJECTIVE:HELP PD was a clinical trial of 301 adults with prediabetes. Participants were randomized to enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers that consisted of a 6-month intensive phase (phase 1) and 18 months of maintenance (phase 2). At 24 months, participants were asked to enroll in phase 3 to assess whether continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with self-directed maintenance (SM) or EUC. RESEARCH DESIGN AND METHODS:In phase 3, LWL participants were randomly assigned to GM or SM. EUC participants remained in the EUC arm and, along with participants in SM, received monthly newsletters. All participants received semiannual dietitian sessions. Anthropometrics and biomarkers were assessed every 6 months. Mixed-effects models were used to assess changes in outcomes over time. RESULTS:Eighty-two of the 151 intervention participants (54%) agreed to participate in phase 3; 41 were randomized to GM and 41 to SM. Of the 150 EUC participants, 107 (71%) continued. Ninety percent of clinic visits were completed. Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly (P < 0.001) in the SM group. CONCLUSIONS:Participants in the GM arm maintained weight loss achieved in phases 1 and 2, while those in the SM arm regained weight. Because group session attendance by the participants in the GM arm was low, it is unclear what intervention components led to successful weight maintenance.

SUBMITTER: Vitolins MZ

PROVIDER: S-EPMC6702609 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial.

Vitolins Mara Z MZ Blackwell Caroline S CS Katula Jeffrey A JA Isom Scott P SP Case L Douglas LD

Diabetes care 20190711 9

<h4>Objective</h4>HELP PD was a clinical trial of 301 adults with prediabetes. Participants were randomized to enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers that consisted of a 6-month intensive phase (phase 1) and 18 months of maintenance (phase 2). At 24 months, participants were asked to enroll in phase 3 to assess whether continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with ...[more]

PMID: 31296648

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Project description:BackgroundSince the Diabetes Prevention Project (DPP) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58%, several studies have translated the DPP methods to public health-friendly contexts. Although these studies have demonstrated short-term effects, no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up.PurposeTo examine the impact of a 24-month, community-based diabetes prevention program on fasting blood glucose, insulin, insulin resistance as well as body weight, waist circumference, and BMI in the second year of follow-up.DesignAn RCT comparing a 24-month lifestyle weight-loss program (LWL) to an enhanced usual care condition (UCC) in participants with prediabetes (fasting blood glucose=95-125 mg/dL). Data were collected in 2007-2011; analyses were conducted in 2011-2012.Setting/participants301 participants with prediabetes were randomized; 261 completed the study. The intervention was held in community-based sites.InterventionThe LWL program was led by community health workers and sought to induce 7% weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity. The UCC received two visits with a registered dietitian and a monthly newsletter.Main outcome measuresThe main measures were fasting blood glucose, insulin, insulin resistance, body weight, waist circumference, and BMI.ResultsIntent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes (controlling for baseline values) revealed that the LWL participants experienced greater decreases in fasting glucose (-4.35 mg/dL); insulin (-3.01 ?U/ml); insulin resistance (-0.97); body weight (-4.19 kg); waist circumference (-3.23 cm); and BMI (-1.40), all p-values <0.01.ConclusionsA diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity.

Project description:ObjectiveBoth excessive and inadequate gestational weight gain (GWG) are associated with adverse health outcomes for the woman and her child. Antidepressant use in pregnancy could affect GWG, based on evidence in nonpregnant women that some antidepressants may cause weight gain and others weight loss. Previous studies of antidepressant use and GWG were small with limited ability to account for confounding, including by maternal mental health status and severity. We assessed the association of antidepressant continuation in pregnancy with GWG among women using antidepressants before pregnancy.Study designOur retrospective cohort study included singleton livebirths from 2001 to 2014 within Kaiser Permanente Washington, an integrated health care system. Data were obtained from electronic health records and linked Washington State birth records. Among women with ≥1 antidepressant fill within 6 months before pregnancy, women who filled an antidepressant during pregnancy were considered "continuers;" women without a fill were "discontinuers." We calculated mean differences in GWG and relative risks (RR) of inadequate and excessive weight gain based on Institute of Medicine guidelines. Using inverse probability of treatment weighting with generalized estimating equations, we addressed differences in maternal characteristics, including mental health conditions.ResultsAmong the 2,887 births, 1,689 (59%) were to women who continued antidepressants in pregnancy and 1,198 (42%) were to discontinuers. After accounting for confounding, continuers had similar weight gain to those who discontinued (mean difference: 1.3 lbs, 95% confidence interval [CI]: -0.1 to 2.8 lbs) and similar risks of inadequate and excessive GWG (RR: 0.95, 95% CI: 0.80-1.14 and RR: 1.06, 95% CI: 0.98-1.14, respectively). Findings were comparable for specific antidepressants and trimesters of exposure.ConclusionWe did not find evidence that continuation of antidepressants in pregnancy led to differences in GWG.Key points· Antidepressant use is associated with weight change in nonpregnant populations.. · Prior evidence on whether antidepressant use in pregnancy affects gestational weight gain is sparse.. · We accounted for confounding by characteristics such as mental health conditions and their severity.. · We found no association between pregnancy antidepressant continuation and gestational weight gain..

Project description:The Treatment for Adolescents With Depression Study evaluated fluoxetine (FLX), cognitive behavioral therapy (CBT), and FLX/CBT combination (COMB) vs pill placebo in 439 adolescents with major depressive disorder. Treatment consisted of 3 stages: (1) acute (12 weeks), (2) continuation (6 weeks), and (3) maintenance (18 weeks).To examine rates of achieving and maintaining sustained response during continuation and maintenance treatments.Randomized controlled trial. Response was determined by blinded independent evaluators.Thirteen US sites.Two hundred forty-two FLX, CBT, and COMB patients in their assigned treatment at the end of stage 1.Stage 2 treatment varied based on stage 1 response. Stage 3 consisted of 3 CBT and/or pharmacotherapy sessions and, if applicable, continued medication.Sustained response was defined as 2 consecutive Clinical Global Impression-Improvement ratings of 1 or 2 ("full response"). Patients achieving sustained response were classified on subsequent nonresponse status.Among 95 patients (39.3%) who had not achieved sustained response by week 12 (29.1% COMB, 32.5% FLX, and 57.9% CBT), sustained response rates during stages 2 and 3 were 80.0% COMB, 61.5% FLX, and 77.3% CBT (difference not significant). Among the remaining 147 patients (60.7%) who achieved sustained response by week 12, CBT patients were more likely than FLX patients to maintain sustained response through week 36 (96.9% vs 74.1%; P = .007; 88.5% of COMB patients maintained sustained response through week 36). Total rates of sustained response by week 36 were 88.4% COMB, 82.5% FLX, and 75.0% CBT.Most adolescents with depression who had not achieved sustained response during acute treatment did achieve that level of improvement during continuation and maintenance therapies. The possibility that CBT may help the subset of adolescents with depression who achieve early sustained response maintain their response warrants further investigation.clinicaltrials.gov Identifier: NCT00006286.

Dataset Information

Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial.

Publications

Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial.

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