Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance (OPT-X)
Status
Enrolling
Conditions
Weight Loss
Obesity Prevention
Weight Change
Weight Loss Maintenance
Treatments
Behavioral: Home-based Resistance Training (HBRT)
Behavioral: Acceptance and Commitment (ACT) Workshops
Behavioral: Reduced Food Variety (RFV)
Behavioral: Buddy Training and Support (BTS)
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
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
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.
Enrollment
544 estimated patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
Single Blind
544 participants in 16 patient groups
Package 1: No WLM Components
No Intervention group
Description:
Participants will receive education and support for weight loss maintenance only.
Package 2: One WLM Component - BTS
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance and Buddy Training and Support.
Treatment:
Behavioral: Buddy Training and Support (BTS)
Package 3: One WLM Component - HBRT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance and Home-based Resistance Training
Treatment:
Behavioral: Home-based Resistance Training (HBRT)
Package 4: Two WLM Components - HBRT+BTS
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and Buddy Training and Support.
Treatment:
Behavioral: Buddy Training and Support (BTS)
Behavioral: Home-based Resistance Training (HBRT)
Package 5: One WLM Component - ACT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Acceptance and Commitment (ACT) Workshops.
Treatment:
Behavioral: Acceptance and Commitment (ACT) Workshops
Package 6: Two WLM Components - BTS+ACT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Buddy Training and Support and ACT Workshops.
Treatment:
Behavioral: Buddy Training and Support (BTS)
Behavioral: Acceptance and Commitment (ACT) Workshops
Package 7: Two WLM Components - HBRT+ACT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and ACT Workshops.
Treatment:
Behavioral: Acceptance and Commitment (ACT) Workshops
Behavioral: Home-based Resistance Training (HBRT)
Package 8: Three WLM Components - HBRT+BTS+ACT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.
Treatment:
Behavioral: Buddy Training and Support (BTS)
Behavioral: Acceptance and Commitment (ACT) Workshops
Behavioral: Home-based Resistance Training (HBRT)
Package 9: One WLM Component - RFV
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety.
Treatment:
Behavioral: Reduced Food Variety (RFV)
Package 10: Two WLM Components - RFV+BTS
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Buddy Training and Support
Treatment:
Behavioral: Buddy Training and Support (BTS)
Behavioral: Reduced Food Variety (RFV)
Package 11: Two WLM Components - RFV+HBRT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Home-based Resistance Training.
Treatment:
Behavioral: Reduced Food Variety (RFV)
Behavioral: Home-based Resistance Training (HBRT)
Package 12: Three WLM Components - RFV+HBRT+BTS
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and Buddy Training and Support.
Treatment:
Behavioral: Buddy Training and Support (BTS)
Behavioral: Reduced Food Variety (RFV)
Behavioral: Home-based Resistance Training (HBRT)
Package 13: Two WLM Components - RFV+ACT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and ACT Workshops.
Treatment:
Behavioral: Reduced Food Variety (RFV)
Behavioral: Acceptance and Commitment (ACT) Workshops
Package 14: Three WLM Components - RFV+BTS+ACT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Buddy Training and Support, and ACT Workshops.
Treatment:
Behavioral: Buddy Training and Support (BTS)
Behavioral: Reduced Food Variety (RFV)
Behavioral: Acceptance and Commitment (ACT) Workshops
Package 15: Three WLM Components - RFV+HBRT+ACT
Active Comparator group
Description:
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and ACT Workshops.
Treatment:
Behavioral: Reduced Food Variety (RFV)
Behavioral: Acceptance and Commitment (ACT) Workshops
Behavioral: Home-based Resistance Training (HBRT)
Package 16: Four WLM Components: RFV+HBRT+BTS+ACT
Experimental group
Description:
Participants 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.
Treatment:
Behavioral: Buddy Training and Support (BTS)
Behavioral: Reduced Food Variety (RFV)
Behavioral: Acceptance and Commitment (ACT) Workshops
Behavioral: Home-based Resistance Training (HBRT)
Trial contacts and locations
1
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Central trial contact
Amy Dobelstein; Gareth Dutton
Data sourced from clinicaltrials.gov
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