ACTIVE_NOT_RECRUITING

Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-12
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04335799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI of at least 30 kg/m\^2
  2. * elevated stress levels based on perceived stress scale score
  3. * self-identified as black race
  1. * pregnant or are planning to become pregnant in the next year
  2. * 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)
  3. * history of psychiatric hospitalization in past 2 years
  4. * history of substance abuse or eating disorder
  5. * any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
  6. * currently taking medications for weight loss

Contacts and Locations

Principal Investigator

Tiffany L Carson, PhD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Tiffany L Carson, PhD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-12
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2021-10-12
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity