NCT04335799

Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training	12-month evidence based weight loss intervention with additional training on stress management strategies
BEHAVIORAL	Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics	12-month evidence based weight loss intervention with an attention control of general women's health topics

Timeline

• Start date: 2021-10-12
• Primary completion: 2026-03-31
• Completion: 2027-03-31
• First posted: 2020-04-06
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States