This clinical trial examines a stress-management enhanced behavioral weight loss intervention in improving weight loss outcomes in black women. Psychological stress is associated with weight gain over time and higher body mass index. This trial may help researchers assess if stress management can improve weight loss outcomes for black women with obesity and elevated stress.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04335799.
PRIMARY OBJECTIVES:
I. Conduct a randomized, controlled trial to determine the effects on body weight of a culturally-targeted, stress-management enhanced behavioral weight loss intervention (BWL-Stress) compared to a standard behavioral weight loss intervention alone (BWL-Alone) among adult black females with obesity and elevated stress.
II. Evaluate the effects of the stress-management enhanced behavioral weight loss intervention on psychological stress as measured by a validated survey instrument and a stress biomarker.
III. Using a multiple mediation model, determine whether the relationship between the stress-management enhanced behavioral weight loss intervention and weight change is mediated by perceived stress, energy intake, and physical activity.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants participate in a behavioral weight loss intervention and receive training on stress management weekly for 4 months, bi-weekly for 2 months, and then monthly for 6 months.
GROUP II: Participants participate in a behavioral weight loss intervention and receive education on general women's health topics weekly for 4 months, bi-weekly for 2 months, and then monthly for 6 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorTiffany Carson
