Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools (NCT04335799) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
United States341 participantsStarted 2021-10-12
Plain-language 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.
Who can participate
Age range
21 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
4-month mean weight change of participants using SECA scale
Timeframe: Baseline to Month 4
2
12-month mean weight change of participants using SECA scale
Timeframe: Baseline to Month 12
Trial details
NCT IDNCT04335799
SponsorH. Lee Moffitt Cancer Center and Research Institute