Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Obesity Prevention, Weight Change, Weight Loss, Weight Loss Maintenance

Being tested

Reduced Food Variety (RFV), Home-based Resistance Training (HBRT), Buddy Training and Support (BTS), Acceptance and Commitment (ACT) Workshops

Keywords

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

Medical subject headings

Body Weight Changes, Weight Loss, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Reduced Food Variety (RFV)Behavioural

  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)Behavioural

  Also called Strength Training, Resistance Training, Weight Lifting, Lifting Weights

  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.

• Buddy Training and Support (BTS)Behavioural

  Also called Buddy Support

  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.

• Acceptance and Commitment (ACT) WorkshopsBehavioural

  Also called ACT Workshop

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 Jan 2025
2. Study start2 Dec 2025
3. Primary completion30 Nov 2028 (estimated)
4. Study completion28 Feb 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Obesity PreventionStudies of the same condition, open and under way.
• More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.