Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Obesity Clinical Trial

— RESET  

Official title:

Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335799
• Other study ID #: MCC-21236
• Secondary ID: R01DK125367
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Alissa Pena
• Phone: 813-745-7710
• Email: Alissa.Pena[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
12-month evidence based weight loss intervention with additional training on stress management strategies
• Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
12-month evidence based weight loss intervention with an attention control of general women's health topics

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-month mean weight change of participants using SECA scale	weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged	Baseline to Month 4
Primary	12-month mean weight change of participants using SECA scale	weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged	Baseline to Month 12
Secondary	mean change in perceived stress using Perceived Stress Scale-10 score	Perceived stress as measured with a validated survey will be assessed at baseline and month to assess changes in participant's stress	Baseline to Month 4
Secondary	mean change in perceived stress using Perceived Stress Scale-10 score	Perceived stress as measured with a validated survey will be assessed at baseline and month 12 to assess changes in participant's stress	Baseline to Month 12

External Links

•   Moffitt Cancer Center Clinical Trials website