Clinical trial NCT04335799: Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
Official title: Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-04-06
Enrollment: 340
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: 4-month mean weight change of participants using SECA scale
timeFrame: Baseline to Month 4
measure: 12-month mean weight change of participants using SECA scale
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: mean change in perceived stress using Perceived Stress Scale-10 score
timeFrame: Baseline to Month 4
measure: mean change in perceived stress using Perceived Stress Scale-10 score
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Tiffany L Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buro AW, Baskin M, Miller D, Ward T, West DS, Gore LR, Gwede CK, Epel E, Carson TL. Rationale and study protocol for a randomized controlled trial to determine the effectiveness of a culturally relevant, stress management enhanced behavioral weight loss intervention on weight loss outcomes of black women. BMC Public Health. 2022 Jan 28;22(1):193. doi: 10.1186/s12889-022-12519-z.