Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics; Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

• Registration Number: NCT04335799
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2021-10-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

• BMI of at least 30 kg/m^2
• elevated stress levels based on perceived stress scale score
• self-identified as black race

Exclusion Criteria

• pregnant or are planning to become pregnant in the next year
• known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose > 126 mg/dL), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder)
• history of psychiatric hospitalization in past 2 years
• history of substance abuse or eating disorder
• any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
• currently taking medications for weight loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight Loss Only	Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics	Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
Weight Loss Plus Stress Management	Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training	Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training

Primary Outcome Measures

Name	Time	Method
4-month mean weight change of participants using SECA scale	Baseline to Month 4	weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged
12-month mean weight change of participants using SECA scale	Baseline to Month 12	weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged

Secondary Outcome Measures

Name	Time	Method
mean change in perceived stress using Perceived Stress Scale-10 score	Baseline to Month 12	Perceived stress as measured with a validated survey will be assessed at baseline and month 12 to assess changes in participant's stress

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States