NCT04335799Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 341 (actual)
- First submitted
- 30 Jan 2020
- Start date
- 12 Oct 2021
- Primary completion date
- 19 Dec 2025
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Obesity
- NCT number
- NCT04335799
What you commit to
- Study type: Interventional
- Participants enrolled: 341
- From 12 Oct 2021 to the primary completion date, 19 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently taking medications for weight loss
Other illness
- 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.
Lab values
- 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)
Other
- pregnant or are planning to become pregnant in the next year
Who the study is looking for
- BMI of at least 30 kg/m\^2
- elevated stress levels based on perceived stress scale score
- self-identified as black race
Age in the registry: 21 years to 75 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.