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Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics.

ABSTRACT: Underserved and minority populations suffer from a disproportionately high prevalence of obesity and related comorbidities. Effective obesity treatment programs delivered in primary care that produce significant weight loss are currently lacking. The purpose of this trial is to test the effectiveness of a pragmatic, high intensity lifestyle-based obesity treatment program delivered within primary care among an underserved population. We hypothesize that, relative to patients who receive usual care, patients who receive a high-intensity, health literacy- and culturally-appropriate lifestyle intervention will have greater percent reductions in body weight over 24?months. Eighteen clinics (N?=?803 patients) serving low income populations with a high proportion of African Americans in Louisiana were randomized to the intervention or usual car. Patients in the intervention participate in a high-intensity lifestyle program delivered by health coaches employed by an academic health center and embedded in the primary care clinics. The program consists of weekly (16 in-person/6 telephone) sessions in the first six months, followed by sessions held at least monthly for the remaining 18?months. Primary care practitioners in usual care receive information on weight management and the current Centers for Medicare and Medicaid Services reimbursement for obesity treatment. The primary outcome is percent weight loss at 24?months. Secondary outcomes include absolute 24-month changes in body weight, waist circumference, blood pressure, fasting glucose and lipids, health-related quality of life, and weight-related quality of life. The results will provide evidence on the effectiveness of implementing high-intensity lifestyle and obesity counseling in primary care settings among underserved populations. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT02561221.

SUBMITTER: Katzmarzyk PT

PROVIDER: S-EPMC5965693 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics.

Katzmarzyk Peter T PT Martin Corby K CK Newton Robert L RL Apolzan John W JW Arnold Connie L CL Davis Terry C TC Denstel Kara D KD Mire Emily F EF Thethi Tina K TK Brantley Phillip J PJ Johnson William D WD Fonseca Vivian V Gugel Jonathan J Kennedy Kathleen B KB Lavie Carl J CJ Price-Haywood Eboni G EG Sarpong Daniel F DF Springgate Benjamin B

Contemporary clinical trials 20180208

Underserved and minority populations suffer from a disproportionately high prevalence of obesity and related comorbidities. Effective obesity treatment programs delivered in primary care that produce significant weight loss are currently lacking. The purpose of this trial is to test the effectiveness of a pragmatic, high intensity lifestyle-based obesity treatment program delivered within primary care among an underserved population. We hypothesize that, relative to patients who receive usual ca ...[more]

PMID: 29408562

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Project description:BackgroundIntensive lifestyle interventions (ILIs) stimulate weight loss in underserved patients with obesity, but the mediators of weight change are unknown.ObjectivesWe aimed to identify the mediators of weight change during an ILI compared with usual care (UC) in underserved patients with obesity.MethodsThe PROPEL (Promoting Successful Weight Loss in Primary Care in Louisiana) trial randomly assigned 18 clinics (n = 803) to either an ILI or UC for 24 mo. The ILI group received an intensive lifestyle program; the UC group had routine care. Body weight was measured; further, eating behaviors (restraint, disinhibition), dietary intake (percentage fat intake, fruit and vegetable intake), physical activity, and weight- and health-related quality of life constructs were measured through questionnaires. Mediation analyses assessed whether questionnaire variables explained between-group variations in weight change during 2 periods: baseline to month 12 (n = 779) and month 12 to month 24 (n = 767).ResultsThe ILI induced greater weight loss at month 12 compared with UC (between-group difference: -7.19 kg; 95% CI: -8.43, -6.07 kg). Improvements in disinhibition (-0.33 kg; 95% CI: -0.55, -0.10 kg), percentage fat intake (-0.25 kg; 95% CI: -0.50, -0.01 kg), physical activity (-0.26 kg; 95% CI: -0.41, -0.09 kg), and subjective fatigue (-0.28 kg; 95% CI: -0.46, -0.10 kg) at month 6 during the ILI partially explained this between-group difference. Greater weight loss occurred in the ILI at month 24, yet the ILI group gained 2.24 kg (95% CI: 1.32, 3.26 kg) compared with UC from month 12 to month 24. Change in fruit and vegetable intake (0.13 kg; 95% CI: 0.05, 0.21 kg) partially explained this response, and no variables attenuated the weight regain of the ILI group.ConclusionsIn an underserved sample, weight change induced by an ILI compared with UC was mediated by several psychological and behavioral variables. These findings could help refine weight management regimens in underserved patients with obesity.This trial was registered at clinicaltrials.gov as NCT02561221.

Dataset Information

Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics.

Publications

Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics.

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