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Active Not Recruiting
NCT04335799
Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
Conditions: Obesity
Sex: Female
Ages: 21 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 341
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Location: Moffitt Cancer Center Tampa Florida
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 Criteria
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
Source: ClinicalTrials.gov (NCT04335799). StuddyBuddy aggregates publicly available trial information.