Lifestyle Changes for Obesity

(SILC Trial)

Recruiting at1 trial location

Overseen by Monica Baskin, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to help African American women in rural Alabama and Mississippi lose weight and improve their health. It uses group classes on healthy living and a home gardening program to teach better eating habits and increase physical activity. The study will see how well these programs work and how easy they are to implement in these communities.

Research Team

Monica Baskin, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for African American women over 30 living in certain Alabama and Mississippi communities, who are overweight or obese with prediabetes or high blood pressure. Participants must be willing to stay in the study for 18 months and not plan to move or become pregnant during this time.

Inclusion Criteria

I live, work, or worship in one of the specified communities and don't plan to move for the next 18 months.

My BMI is over 25 and I have been diagnosed with pre-diabetes or hypertension in the last 2 years.

You identify yourself as Black and/or African American.

Exclusion Criteria

A baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate

Being or planning to become pregnant during the 18-month study duration

Medical contraindications

Treatment Details

Interventions

• Educational Group Weight Loss Classes (Behavioural Intervention)
• Home Gardening Intervention (Behavioural Intervention)

Trial Overview The study tests two weight loss programs: one involving educational group classes on weight loss, and another focusing on home gardening as a way to improve diet. The aim is to see which program better helps reduce obesity, diabetes, and high blood pressure.

Participant Groups

Group I: Educational Group Weight Loss Classes PLUS Home Gardening Intervention Experimental Treatment 2 Interventions

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 II: Educational Group Weight Loss Classes Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Dodie T. McElmurray

University of Mississippi Medical Center

Chief Executive Officer since 2024

BS in Nursing from Delta State University, MSN/MBA from University of Phoenix

Dr. LouAnn Woodward

University of Mississippi Medical Center

Chief Medical Officer since 2015

MD from University of Mississippi Medical Center