NCT05625321

Stepping Into Lifestyle Changes

Community-Based Strategies to Reduce Cardiometabolic Disease in the Deep South

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to promote healthy weight loss among African American women, age 30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or worship in select rural communities throughout Alabama and Mississippi. The goal of the study is to help reduce the burden of obesity, diabetes, and high blood pressure for these women and to collect information on the reach, effectiveness, adoption, implementation, maintenance, and cost effectiveness of our two evidence-base weight loss programs.

Detailed description

This study leverages two evidence-based interventions (EBIs) that have been culturally-adapted for the target population and have previously achieved clinically-relevant weight loss and other clinical outcomes (educational group weight loss intervention) along with improvements in diet and physical activity (home gardening intervention). Combining these EBIs addresses multiple domains (behavioral, personal environment, sociocultural) and levels (individual, interpersonal, community) of influence on risk factors for obesity and other cardiometabolic diseases prevalent in the Deep South. These interventions, delivered by local lay staff and non-academic partners, have a high potential for sustainability; however, there is a need to further evaluate the external validity and implementation-related barriers and facilitators to maximize reach, adoption and implementation. The investigators will employ a pragmatic, multilevel, cluster-randomized, type 1 hybrid effectiveness-implementation trial. A total of 264 Black women (age ≥ 30 years) with overweight or obesity and pre-diabetic or hypertensive from 12 rural counties (6 Alabama, 6 Mississippi) will receive either the combined educational group weight loss intervention plus a home gardening intervention or the educational group weight loss classes alone. The specific aims are to compare interventions on: (1) primary outcomes related to implementation effectiveness (reach, adoption, maintenance of health behaviors), (2) secondary outcomes on clinical effectiveness, and (3) cost effectiveness. Findings will inform discussions with coalition partners to achieve our long-term goal of widely disseminating and sustaining multi-level interventions to reduce the multiple chronic disease burden and health disparities in the Deep South.

Conditions

• Overweight and Obesity
• Pre-Diabetes
• High Blood Pressure

Interventions

Type	Name	Description
BEHAVIORAL	Educational Group Weight Loss Classes	Participants will be provided with educational materials on weight loss, and have opportunities to increase their exercise and make changes to their diet.
BEHAVIORAL	Home Gardening Intervention	Participants will receive tools to establish their own home garden, increasing their access to fresh fruits and vegetables.

Timeline

• Start date: 2023-03-27
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2022-11-22
• Last updated: 2025-08-27

Locations

2 sites across 1 country: United States