Forge AHEAD Center #1

ClinicalTrials.gov link

Diseases or Conditions Being Studied
Obesity treatment, diabetes prevention, HTN control

Communities of Focus
 Rural, community-dwelling Black Americans with obesity and pre-diabetes

Study Site 
Rural communities throughout Alabama and Mississippi

Study Design
Hybrid type 3 implementation trial
Intervention description: multi-level lifestyle modification intervention combining lay health coaches and community gardens

Levels of Action
1) individual level (health behaviors),
2) interpersonal (peer norms),
3) community (built environment, food environment)

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.

Non-academic Partners
AL and MS Cooperative Extension

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

Nearly 3 out of 4 adults in the United States (US) live with overweight or obesity (body mass index (BMI) of ≥ 25 kg/m2), with the highest rates among Blacks, rural residents, and lower socioeconomic groups. Obesity is associated with cardiometabolic diseases like diabetes, heart disease and stroke, well as multiple cancers. Over the past decade, trends in obesity have been generally stable for men, but increased significantly among women. This is particularly true among Black women who have an obesity prevalence of 56.9% compared to 39.8% in White women. Black women living in rural settings have higher rates of obesity compared to their same race/sex peers in urban settings. Evidence-based interventions (EBIs) that promote weight loss, healthier diet and physical activity are effective at slowing the conversion of pre-diabetes mellitus (pre-DM) and hypertension (HTN) to diabetes and heart failure, respectively. However, these interventions are often underutilized by populations at highest risk, including Black women living in the rural Deep South.

The mission of Forge AHEAD Center is to promote health equity and reduce the burden of cardiometabolic diseases across the Deep South. Consistent with the Center’s theme (applying a precision public health approach across the care continuum to achieve health equity), this study leverages two EBIs led by our team that have been previously culturally-adapted for the target population and achieved clinically-relevant weight loss and other clinical outcomes (group-based weight loss intervention) along with improvements in diet and physical activity (individual 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.

We 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-DM or HTN from 12 rural counties (6 Alabama, 6 Mississippi) will receive either the combined group-based weight loss intervention plus individual gardening intervention or the group-based weight loss intervention 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.