Skip to main content
Clinical Trials/NCT05625321
NCT05625321Active, not recruitingNot Applicable

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

University of Alabama at Birmingham2 sites in 1 country273 target enrollmentStarted: March 27, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
273
Locations
2
Primary Endpoint
Weight

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Educational Group Weight Loss Classes

Active Comparator

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.

Intervention: Educational Group Weight Loss Classes (Behavioral)

Educational Group Weight Loss Classes PLUS Home Gardening Intervention

Experimental

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.

Intervention: Educational Group Weight Loss Classes (Behavioral)

Educational Group Weight Loss Classes PLUS Home Gardening Intervention

Experimental

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.

Intervention: Home Gardening Intervention (Behavioral)

Outcomes

Primary Outcomes

Weight

Time Frame: 0, 6, and 12 months

Changes in Weight, measured in pounds

BMI

Time Frame: 0, 6, and 12 months

Changes in BMI, calculated as a person's weight in kilograms divided by the square of height in meters

Dietary Intake

Time Frame: 0, 6, and 12 months

Changes in diet, measured using a questionnaire

Waist Circumference

Time Frame: 0, 6, and 12 months

Changes in waist circumference, measured in centimeters

Secondary Outcomes

  • Physical Activity(0, 6, and 12 months)
  • Cholesterol Levels(0, 6, and 12 months)
  • Diastolic and Systolic Blood Pressure(0, 6, and 12 months)
  • Fasting Glucose(0, 6, and 12 months)
  • Perceived Quality of Life(0, 6, and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Monica L Baskin

Adjunct Professor

University of Alabama at Birmingham

Study Sites (2)

Loading locations...

Similar Trials