Forge AHEAD Center #1

African American women at a community event

Stepping Into Lifestyle Changes (SILC)

Center:
Project Number:
1
Project Period:
03/27/2023 - 06/30/2026

ClinicalTrials.gov link

Diseases or Conditions Being Studied
Overweight and obesity, Prediabetes, high blood pressure

Communities of Focus
Black and/or African American women 30 years or older

Study Site 
Rural communities throughout Alabama and Mississippi

Study Objectives
Reduce the burden of obesity, diabetes, and high blood pressure among African American women and to collect information on the reach, effectiveness, adoption, implementation, maintenance, and cost effectiveness of our two evidence-base weight loss programs.

Intervention or Treatment

  • Educational Group Weight Loss Classes: Participants will participate in a 12-month weight loss program, taught by lay health educators, and designed to promote and encourage healthy weight loss, dietary changes, and increased physical activity. Participants will attend 90-minute sessions weekly for 6 months, bi-weekly for 3 months, and monthly for 3 months.
  • Home Gardening Intervention: Participants will receive the educational group weight loss classes PLUS a home gardening intervention. 

Abstract

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.

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.

Roles

Monica Baskin, PhD
Principal Investigator
Norma Dawkins, CFS, PhD
Subcontract Principal Investigator
Angela Duck, PhD, RN
Subcontract Principal Investigator
Jaimie Richards, BA, BS, PhD
Project Coordinator