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Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

NCT04335799•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

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

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

October 12, 2021

Primary Completion Date

March 31, 2026

Completion Date

March 31, 2027

Last Updated

February 27, 2026

Enrollment

341

ACTUAL participants

Conditions

Obesity

Interventions

Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

BEHAVIORAL

Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics

BEHAVIORAL

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RECRUITINGNA

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Inclusion Criteria

Exclusion Criteria

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