Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools (RESET)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training; Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alissa Pena; Phone Number: 813-745-7710; Email: Alissa.Pena@moffitt.org
• Study Contact Backup: Name: Tiffany L Carson, PhD; Phone Number: 81-745-4944; Email: Tiffany.Carson@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Alissa Pena; Phone Number: 813-745-7710; Email: Alissa.Pena@moffitt.org
      • Principal Investigator: Tiffany Carson, PhD
      • Contact: Jazmin Henderson; Phone Number: 813-745-5588; Email: Jazmin.Henderson@moffitt.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weight Loss Plus Stress Management; Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training	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
Active Comparator: Weight Loss Only; Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Tiffany L Carson, PhD, Moffitt Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MCC-21236; R01DK125367 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No