Stepping Into Lifestyle Changes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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

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Overweight and Obesity Pre-Diabetes High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Educational Group Weight Loss Classes

Intervention Type BEHAVIORAL

Participants will be provided with educational materials on weight loss, and have opportunities to increase their exercise and make changes to their diet.

Educational Group Weight Loss Classes PLUS Home Gardening Intervention

Participants will receive the educational group weight loss classes PLUS a home gardening intervention. The gardening intervention will be led by local Master Gardeners (MGs) who will help guide participants in setting-up and maintaining their garden.

Group Type EXPERIMENTAL

Educational Group Weight Loss Classes

Intervention Type BEHAVIORAL

Participants will be provided with educational materials on weight loss, and have opportunities to increase their exercise and make changes to their diet.

Home Gardening Intervention

Intervention Type BEHAVIORAL

Participants will receive tools to establish their own home garden, increasing their access to fresh fruits and vegetables.

Interventions

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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.

Intervention Type BEHAVIORAL

Home Gardening Intervention

Participants will receive tools to establish their own home garden, increasing their access to fresh fruits and vegetables.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* self-identifies as Black and/or African American
* ≥ 30 years old
* a measured BMI \>25 kg/m2 and at least one other cardiometabolic risk factor (physician diagnosis of pre-diabetes and/or hypertension within past 2 years)
* lives, works, or worships in one of the 12 intervention communities and expresses no intentions to move outside of that community in the 18 months following enrollment
* a willingness to participate in the study for the 18-months duration.

Exclusion Criteria

* being or planning to become pregnant during the 18-month study duration
* a baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate
* medical contraindications

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes