Trials Today

Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Purpose

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.

Condition

Obesity

Eligibility

Eligible Ages: Between 21 Years and 75 Years
Eligible Sex: Female
Accepts Healthy Volunteers: Yes

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

Moffitt Cancer Center
Tampa, Florida 33612

Contact:
Alissa Pena
813-745-7710
Alissa.Pena@moffitt.org

More Details

NCT ID: NCT04335799
Status: Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Study Contact

Alissa Pena
813-745-7710
Alissa.Pena@moffitt.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.