Optimizing extended care to help people keep weight off
OPT-X: OPTimizing an EXtended Care Intervention to Promote Weight Loss Maintenance
NA · University of Alabama at Birmingham · NCT06785064
This program will test which combination of four low‑burden supports helps adults with obesity who have lost weight keep that weight off.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 544 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06785064 on ClinicalTrials.gov |
What this trial studies
Adults with obesity first complete a 16‑week weight loss program, and those who lose at least 5% of their starting weight move on to the extended care phase. In the second phase participants are randomly assigned to receive none, one, two, three, or all four maintenance components (reduced food variety, home‑based resistance training, buddy support, and acceptance and commitment workshops). The study uses a factorial design to identify which combination produces the best long‑term weight maintenance and to examine whether certain components work better for particular subgroups. Sessions are delivered using internet videoconferencing and home‑based activities to limit participant burden.
Who should consider this trial
Good fit: Ideal candidates are adults (age >18) with BMI >30 who can access Zoom, complete a 16‑week initial weight loss program, and lose at least 5% of their starting weight.
Not a fit: People who do not achieve the required 5% weight loss during the initial program, those with recent major cardiac events, uncontrolled hypertension, certain chronic lung diseases, type 1 diabetes, recent use of weight‑loss medications, pregnancy, or other listed exclusions are unlikely to receive benefit from the Phase 2 interventions.
Why it matters
Potential benefit: If successful, this approach could identify cost‑effective, low‑burden support packages that help people keep weight off long term.
How similar studies have performed: Behavioral approaches like reduced food variety, home exercise, social support, and acceptance‑based therapies have shown mixed results individually, and combining them in this factorial optimization design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Body mass index (BMI) \>30 kg/m2 * Has regular access to internet (to access Zoom videoconferencing platform) * If indicated during screening, willing to obtain medical clearance for exercise from their healthcare provider prior to enrollment Exclusion Criteria: * Current or recent (past 6 months) use of prescription weight loss medications * Weight loss \>10 pounds in past 6 months (other than postpartum) * Pregnancy or anticipating pregnancy * Another household member already participating in the study * Participation in another randomized research project * Uncontrolled hypertension (blood pressure \>160/100 mm Hg at screening) * 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 * Unable to identify potential buddy (i.e., adult friend or family member) for extended care intervention phase * Residing \>50 miles from the university (to attend assessment visits) * Planning to relocate out of the area in the next 18 months * Does not have internet access * Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Gareth Dutton
- Email: gdutton@uabmc.edu
- Phone: 205-934-6876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity Prevention, Weight Change, Weight Loss, Weight Loss Maintenance, weight loss maintenance, weight loss, weight change, health behavior