ClinicalTrials.gg
RecruitingNCT06785064OPT-XUpdated Jan 7, 2026

Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance

An interventional study of Reduced Food Variety (RFV) and Home-based Resistance Training (HBRT) in Obesity Prevention, Weight Change and Weight Loss, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.

Primary conditionWeight LossRegistry: Body Weight ChangesReclassifiedWhy we changed it
Registry
Body Weight Changes — the first condition term the registry derived for this study.
ClinicalTrials.gg
Weight Loss
Why
  1. The study's listed conditions name Weight Loss, a narrower term within Body Weight Changes.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
544
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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:

  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.

02

Conditions studied

  • Obesity Prevention
  • Weight Change
  • Weight Loss
  • Weight Loss Maintenance

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Keywords

  • weight loss maintenance
  • weight loss
  • weight change
  • health behavior
  • reduced food variety
  • ACT workshop
  • buddy support
  • home-based resistance training
  • weight training
03

In context

Weight Loss Reclassified

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

This study's planned enrollment of 544 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Compared within Weight Loss, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Weight Changes. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >18 years
  • (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

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; 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 ; read/understand English; accept random assignment
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
544 participants (estimated)

Study arms

  • No intervention
    Package 1: No WLM Components

    Participants will receive education and support for weight loss maintenance only.

  • Active comparator
    Package 2: One WLM Component - BTS

    Participants will receive education and support for weight loss maintenance and Buddy Training and Support.

    Behavioral: Buddy Training and Support (BTS)

  • Active comparator
    Package 3: One WLM Component - HBRT

    Participants will receive education and support for weight loss maintenance and Home-based Resistance Training

    Behavioral: Home-based Resistance Training (HBRT)

  • Active comparator
    Package 4: Two WLM Components - HBRT+BTS

    Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and Buddy Training and Support.

    Behavioral: Home-based Resistance Training (HBRT) · Behavioral: Buddy Training and Support (BTS)

  • Active comparator
    Package 5: One WLM Component - ACT

    Participants will receive education and support for weight loss maintenance as well as Acceptance and Commitment (ACT) Workshops.

    Behavioral: Acceptance and Commitment (ACT) Workshops

  • Active comparator
    Package 6: Two WLM Components - BTS+ACT

    Participants will receive education and support for weight loss maintenance as well as Buddy Training and Support and ACT Workshops.

    Behavioral: Buddy Training and Support (BTS) · Behavioral: Acceptance and Commitment (ACT) Workshops

  • Active comparator
    Package 7: Two WLM Components - HBRT+ACT

    Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and ACT Workshops.

    Behavioral: Home-based Resistance Training (HBRT) · Behavioral: Acceptance and Commitment (ACT) Workshops

  • Active comparator
    Package 8: Three WLM Components - HBRT+BTS+ACT

    Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.

    Behavioral: Home-based Resistance Training (HBRT) · Behavioral: Buddy Training and Support (BTS) · Behavioral: Acceptance and Commitment (ACT) Workshops

  • Active comparator
    Package 9: One WLM Component - RFV

    Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety.

    Behavioral: Reduced Food Variety (RFV)

  • Active comparator
    Package 10: Two WLM Components - RFV+BTS

    Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Buddy Training and Support

    Behavioral: Reduced Food Variety (RFV) · Behavioral: Buddy Training and Support (BTS)

  • Active comparator
    Package 11: Two WLM Components - RFV+HBRT

    Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Home-based Resistance Training.

    Behavioral: Reduced Food Variety (RFV) · Behavioral: Home-based Resistance Training (HBRT)

  • Active comparator
    Package 12: Three WLM Components - RFV+HBRT+BTS

    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.

    Behavioral: Reduced Food Variety (RFV) · Behavioral: Home-based Resistance Training (HBRT) · Behavioral: Buddy Training and Support (BTS)

  • Active comparator
    Package 13: Two WLM Components - RFV+ACT

    Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and ACT Workshops.

    Behavioral: Reduced Food Variety (RFV) · Behavioral: Acceptance and Commitment (ACT) Workshops

  • Active comparator
    Package 14: Three WLM Components - RFV+BTS+ACT

    Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Buddy Training and Support, and ACT Workshops.

    Behavioral: Reduced Food Variety (RFV) · Behavioral: Buddy Training and Support (BTS) · Behavioral: Acceptance and Commitment (ACT) Workshops

  • Active comparator
    Package 15: Three WLM Components - RFV+HBRT+ACT

    Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and ACT Workshops.

    Behavioral: Reduced Food Variety (RFV) · Behavioral: Home-based Resistance Training (HBRT) · Behavioral: Acceptance and Commitment (ACT) Workshops

  • Experimental
    Package 16: Four WLM Components: RFV+HBRT+BTS+ACT

    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.

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

Interventions

  • BehavioralReduced Food Variety (RFV)

    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.

  • BehavioralHome-based Resistance Training (HBRT)

    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.

    Also known as: Strength Training, Resistance Training, Weight Lifting, Lifting Weights

  • BehavioralBuddy Training and Support (BTS)

    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.

    Also known as: Buddy Support

  • BehavioralAcceptance and Commitment (ACT) Workshops

    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.

    Also known as: ACT Workshop

06

What researchers measure

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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Nov 2028, 35 months after the start.

Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 35 months is above that.

Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2025
First posted
Jan 20, 2025
StartActual
Dec 2, 2025
Primary completionEst.
Nov 30, 2028
CompletionEst.
Feb 28, 2029
Last update
Jan 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06785064
Responsible party
Gareth R. Dutton PhD (Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Jan 20, 2025
Start date
Dec 2, 2025
Primary completion
Nov 30, 2028 (estimated)
Completion
Feb 28, 2029 (estimated)
Last update
Jan 7, 2026

Study contacts

Gareth Dutton
Contact
gdutton@uabmc.edu
205-934-6876
Amy Dobelstein
Contact
adobelst@uabmc.edu
205-975-1059

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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