Dataset Information

Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

ABSTRACT:

Background

Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking.

Methods

We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months.

Results

All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events.

Conclusions

A high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).

SUBMITTER: Katzmarzyk PT

PROVIDER: S-EPMC7493523 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

Katzmarzyk Peter T PT Martin Corby K CK Newton Robert L RL Apolzan John W JW Arnold Connie L CL Davis Terry C TC Price-Haywood Eboni G EG 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 Sarpong Daniel F DF Springgate Benjamin B

The New England journal of medicine 20200901 10

<h4>Background</h4>Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking.<h4>Methods</h4>We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle interv ...[more]

PMID: 32877581

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Project description:BACKGROUND:Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov. OBJECTIVE:This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment. METHODS:This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery. RESULTS:This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024. CONCLUSIONS:This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country. TRIAL REGISTRATION:ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/15499.

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Dataset Information

Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

Background

Methods

Results

Conclusions

Publications

Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

Similar Datasets

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