RECRUITING

Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance

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 study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people. * The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance. * The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people. Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off. The four components participants could be assigned to in Phase 2 are: 1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly 2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home 3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant 4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.

Official Title

OPT-X: OPTimizing an EXtended Care Intervention to Promote Weight Loss Maintenance

Quick Facts

Study Start:2025-05-28
Study Completion:2029-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06785064

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>18 years
  2. * Body mass index (BMI) \>30 kg/m2
  3. * Has regular access to internet (to access Zoom videoconferencing platform)
  4. * If indicated during screening, willing to obtain medical clearance for exercise from their healthcare provider prior to enrollment
  1. * Current or recent (past 6 months) use of prescription weight loss medications
  2. * Weight loss \>10 pounds in past 6 months (other than postpartum)
  3. * Pregnancy or anticipating pregnancy
  4. * Another household member already participating in the study
  5. * Participation in another randomized research project
  6. * Uncontrolled hypertension (blood pressure \>160/100 mm Hg at screening)
  7. * Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last 6 months; unstable angina within the past 6 months; NYHA Class III or IV congestive heart failure; type 1 diabetes; and chronic lung diseases that limit physical activity
  8. * Unable to identify potential buddy (i.e., adult friend or family member) for extended care intervention phase
  9. * Residing \>50 miles from the university (to attend assessment visits)
  10. * Planning to relocate out of the area in the next 18 months
  11. * Does not have internet access
  12. * Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment

Contacts and Locations

Study Contact

Gareth Dutton
CONTACT
205-934-6876
gdutton@uabmc.edu
Amy Dobelstein
CONTACT
205-975-1059
adobelst@uabmc.edu

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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 Date2025-05-28
Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-05-28
Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

  • weight loss maintenance
  • weight loss
  • weight change
  • health behavior
  • reduced food variety
  • ACT workshop
  • buddy support
  • home-based resistance training
  • weight training

Additional Relevant MeSH Terms

  • Obesity Prevention
  • Weight Change
  • Weight Loss
  • Weight Loss Maintenance