Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
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
🗓️ Study Start (Actual) 12 October 2021
🗓️ Primary Completion (Estimated) 31 January 2025
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 340
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Tampa, Florida, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 January 2020
  • First Submitted that Met QC Criteria 2 April 2020
  • First Posted 6 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified July 2024