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NCT Number: NCT06785064

Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance

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.

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Key information

Conditions

Obesity Prevention Behavior Body Weight Body Weight Changes Health Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Change Weight Loss Weight Loss Maintenance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced Food Variety (RFV)

Behavioral

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.

Home-based Resistance Training (HBRT)

Behavioral

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.

Other names: Strength Training, Resistance Training, Weight Lifting, Lifting Weights

Buddy Training and Support (BTS)

Behavioral

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.

Other names: Buddy Support

Acceptance and Commitment (ACT) Workshops

Behavioral

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.

Other names: ACT Workshop

Primary outcomes

  1. Change in weight from time of randomization to 12 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Dobelstein

CONTACT

[email protected]

205-975-1059

Gareth Dutton

CONTACT

[email protected]

205-934-6876

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: OPT-X

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 20, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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