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OpenTrials
Active, Not Recruiting

NCT Number: NCT04335799

Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Behavioral

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

Behavioral

12-month evidence based weight loss intervention with an attention control of general women's health topics

Primary outcomes

  1. 4-month mean weight change of participants using SECA scale

    Time frame: Baseline to Month 4

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

  2. 12-month mean weight change of participants using SECA scale

    Time frame: Baseline to Month 12

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

Secondary outcomes

  1. mean change in perceived stress using Perceived Stress Scale-10 score

    Time frame: Baseline to Month 4

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

  2. mean change in perceived stress using Perceived Stress Scale-10 score

    Time frame: Baseline 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: RESET

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Apr 6, 2020
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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