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Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Not Applicable
Recruiting
Conditions
Obesity
Registration Number
NCT04335799
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
340
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
4-month mean weight change of participants using SECA scaleBaseline to Month 4

weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged

12-month mean weight change of participants using SECA scaleBaseline to Month 12

weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged

Secondary Outcome Measures
NameTimeMethod
mean change in perceived stress using Perceived Stress Scale-10 scoreBaseline to Month 12

Perceived stress as measured with a validated survey will be assessed at baseline and month 12 to assess changes in participant's stress

Trial Locations

Locations (1)

Moffitt Cancer Center

🇺🇸

Tampa, Florida, United States

Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Alissa Pena
Contact
813-745-7710
Alissa.Pena@moffitt.org
Jazmin Henderson
Contact
813-745-5588
Jazmin.Henderson@moffitt.org
Tiffany Carson, PhD
Principal Investigator

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