Stepping Into Lifestyle Changes

NCT05625321 | Active Not Recruiting

• 2 other identifiers: 300009477P50MD017338
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity; Pre-Diabetes; High Blood Pressure

Outcome Measures

Primary Outcomes (4)

• Weight

  Changes in Weight, measured in pounds

  0, 6, and 12 months

• BMI

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

  0, 6, and 12 months

• Waist Circumference

  Changes in waist circumference, measured in centimeters

  0, 6, and 12 months

• Dietary Intake

  Changes in diet, measured using a questionnaire

  0, 6, and 12 months

Secondary Outcomes (6)

• Diastolic and Systolic Blood Pressure

  0, 6, and 12 months

• Fasting Glucose

  0, 6, and 12 months

• Cholesterol Levels

  0, 6, and 12 months

• Physical Activity

  0, 6, and 12 months

• Physical Activity

  0, 6, and 12 months

Study Arms (2)

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.

Behavioral: Educational Group Weight Loss Classes

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.

Behavioral: Educational Group Weight Loss Classes; Behavioral: Home Gardening Intervention

Interventions

Educational Group Weight Loss Classes 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; Educational Group Weight Loss Classes PLUS Home Gardening Intervention

Home Gardening Intervention BEHAVIORAL

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

Educational Group Weight Loss Classes PLUS Home Gardening Intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Mississippi Medical Center: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

The University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Glucose Intolerance; Hypertension

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Monica Baskin, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 22, 2022
• Study Start: March 27, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)