TrialGlobe

Clinical trial

Stepping Into Lifestyle Changes

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05625321

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to Not listed
SexFemale
Healthy volunteersAccepted
ConditionOverweight and Obesity, Pre-Diabetes, High Blood Pressure

Full registry criteria

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

Treatments and study arms

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.

Home Gardening Intervention

Behavioral

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

Primary outcomes

Weight0, 6, and 12 months

Changes in Weight, measured in pounds

BMI0, 6, and 12 months

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

Waist Circumference0, 6, and 12 months

Changes in waist circumference, measured in centimeters

Dietary Intake0, 6, and 12 months

Changes in diet, measured using a questionnaire

Study locations

2 locations were listed when this page was built. The first 40 are shown.

The University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States
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The University of Mississippi Medical Center🇺🇸 Jackson, Mississippi, United States
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