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Clinical Trial 21236

Cancer Type: N/A
Study Type: Prevention
NCT#: NCT04335799

Phase: N/A
Principal Investigator: Carson, Tiffany

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

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

Summary

The purpose of this study 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.

Objective

Conduct a randomized, controlled trial to determine the effects on body weight of a culturally-targeted, stress-management enhanced BWL intervention (BWL-Stress) compared to a standard BWL intervention alone (BWL-Alone) among adult black females with obesity and elevated stress Evaluate the effects of the stress-management enhanced BWL intervention on psychological stress as measured by a validated survey instrument and a stress biomarker. Using a multiple mediation model, determine whether the relationship between the stress-management enhanced BWL intervention and weight change is mediated by perceived stress, energy intake, and physical activity.

Treatments

Therapies

Medications

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.

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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