Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance
OPT-X
OPT-X: OPTimizing an EXtended Care Intervention to Promote Weight Loss Maintenance
2 other identifiers
interventional
544
1 country
1
Brief Summary
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:
- Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly
- Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home
- Buddy Training and Support: Having a friend or "buddy" get trained to support the participant
- Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedStudy Start
First participant enrolled
December 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
January 7, 2026
January 1, 2026
3 years
January 15, 2025
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in weight from time of randomization to 12 months
The primary outcome of the study is the change in weight measurement from the time of randomization (after Phase 1 initial weight loss/the beginning of Phase 2) until the follow up visit 12 months later. Participants' body weight will be measured to the nearest 0.1 kg at each point using a calibrated electronic scale. The change between these two measures will be calculated.
12 months
Study Arms (16)
Package 1: No WLM Components
NO INTERVENTIONParticipants will receive education and support for weight loss maintenance only.
Package 2: One WLM Component - BTS
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance and Buddy Training and Support.
Package 3: One WLM Component - HBRT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance and Home-based Resistance Training
Package 4: Two WLM Components - HBRT+BTS
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and Buddy Training and Support.
Package 5: One WLM Component - ACT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Acceptance and Commitment (ACT) Workshops.
Package 6: Two WLM Components - BTS+ACT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Buddy Training and Support and ACT Workshops.
Package 7: Two WLM Components - HBRT+ACT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and ACT Workshops.
Package 8: Three WLM Components - HBRT+BTS+ACT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.
Package 9: One WLM Component - RFV
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety.
Package 10: Two WLM Components - RFV+BTS
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Buddy Training and Support
Package 11: Two WLM Components - RFV+HBRT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Home-based Resistance Training.
Package 12: Three WLM Components - RFV+HBRT+BTS
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and Buddy Training and Support.
Package 13: Two WLM Components - RFV+ACT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety and ACT Workshops.
Package 14: Three WLM Components - RFV+BTS+ACT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Buddy Training and Support, and ACT Workshops.
Package 15: Three WLM Components - RFV+HBRT+ACT
ACTIVE COMPARATORParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and ACT Workshops.
Package 16: Four WLM Components: RFV+HBRT+BTS+ACT
EXPERIMENTALParticipants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.
Interventions
Participants engaged in reduced food variety (RFV) will be asked to choose a few high-calorie, low nutrient main meals and snacks to eat regularly. At the beginning of each month, they will choose one main meal (entrée) to eat at least 2 times a week and one snack food to eat at least 4 times a week within the month. They will have the option to keep or change their main meal and snack options from month to month.
Participants assigned to receive home-based resistance training (also called strength training or lifting weights) will be asked to engage in at-home exercises that strengthen muscles at least 2 days each week (≤45 minutes per home session) and track their progress. They will be asked to attend 6, 1-hour group-based skills training workshops (in-person and/or remotely via Zoom) during the first two months of Phase 2 to learn these skills. They will receive exercise plans and equipment (sets of dumbbells, a rack to hold the dumbbells, and an exercise mat) needed to complete exercises.
Participants assigned to buddy training and support will be asked to identify an eligible friend or family member who is over 18 years old that can be their "buddy". Study staff will contact the buddy to be sure they are eligible, willing, and have all the details they need. The participant's buddy will be asked to attend up to 6 training sessions with the study staff, so they can learn the best ways to support the participant during the program. After the buddy completes training, they will be asked to check in with the participant 1-2 times each week about their progress.
Participants assigned to receive Acceptance and Commitment (ACT) Workshops will be asked to attend 6, 1-hour group-based skills training workshops (in-person and/or remotely via Zoom) during the first three months of Phase 2. These workshops will help them develop skills to handle tough thoughts about weight control, keep their values in mind, and be mindful of their decisions and the impact of their decisions related to weight control. They will also be asked to apply ACT skills regularly during the rest of Phase 2.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 15, 2025
First Posted
January 20, 2025
Study Start
December 2, 2025
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
February 28, 2029
Last Updated
January 7, 2026
Record last verified: 2026-01