Weight loss program with stress management for black women
Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention
This study tests whether adding stress management techniques to a weight loss program can help Black women with obesity lose more weight than a standard weight loss program alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | Female |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT04335799 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a behavioral weight loss program that incorporates culturally targeted stress management strategies specifically for adult black females with obesity and elevated stress levels. Participants will be randomly assigned to either receive the enhanced weight loss intervention with stress management or the standard weight loss program alone over the course of 26 sessions. The study seeks to determine if the addition of stress management can lead to greater weight loss outcomes compared to the traditional approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adult black females with a BMI of at least 30 kg/m² and elevated stress levels.
Not a fit: Patients who are pregnant, have major medical or psychological conditions affecting weight loss, or are currently taking medications for weight loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to more effective weight loss strategies tailored for black women, improving their overall health and well-being.
How similar studies have performed: Other studies have shown success with behavioral weight loss interventions, but the specific combination of stress management and culturally targeted approaches in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Tiffany L Carson, PhD — Moffitt Cancer Center
- Study coordinator: Alissa Pena
- Email: Alissa.Pena@moffitt.org
- Phone: 813-745-7710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.