Extended Care Interventions for Weight Loss Maintenance

(OPT-X Trial)

Overseen By Amy Dobelstein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

544 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using prescription weight loss medications or have used them in the past 6 months.

What data supports the effectiveness of the treatment Optimizing an Extended Care Intervention for weight loss maintenance?

Research suggests that a continuous care model, which includes ongoing professional support, skills training, social support, and exercise, can help people maintain weight loss over the long term. This approach has been shown to be effective in managing obesity by enhancing the maintenance of weight loss. ^{1 2 3 4 5}

Is the Extended Care Intervention for Weight Loss Maintenance safe for humans?

The available research does not provide specific safety data for the Extended Care Intervention for Weight Loss Maintenance, but it does mention that safety was assessed in a pilot trial for weight loss in older adults with obesity. ^{4 6 7 8 9}

How is the treatment 'Optimizing an Extended Care Intervention' unique for weight loss maintenance?

This treatment is unique because it focuses on extended care, which includes ongoing professional support, skills training, social support, and exercise to help maintain weight loss over the long term. Unlike typical short-term weight loss programs, it emphasizes continuous care to prevent weight regain. ^{2 5 6 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals who have successfully lost at least 5% of their body weight and are looking to maintain that weight loss. It's ideal for those interested in trying different strategies, such as limiting food variety, home-based exercises, buddy support systems, or learning coping skills through workshops.

Inclusion Criteria

I am older than 18.

Body mass index (BMI) >30 kg/m2

Has regular access to internet (to access Zoom videoconferencing platform)

Exclusion Criteria

I have lost more than 10 pounds in the last 6 months, not due to childbirth.

I have a history of type 1 diabetes.

Another household member already participating in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Weight Loss Program

Participants engage in a 16-week weight loss program with weekly group sessions and support from a Wellness Coach

16 weeks

Weekly group sessions

Phase 2 Extended Care

Participants who lose 5% or more of their weight continue to extended care, using assigned weight loss maintenance components for 12 months

12 months

Periodic check-ins with Wellness Coach

Follow-up

Participants are monitored for weight maintenance effectiveness after the extended care phase

12 months

4 weight measurements and surveys

Treatment Details

Interventions

• Optimizing an Extended Care Intervention

Trial Overview The study tests combinations of four methods: eating fewer types of high-calorie foods (RFV), strength-building workouts at home (HBRT), getting support from a trained friend (BTS), and attending workshops on handling emotions related to weight control (ACT). Participants will be randomly assigned a mix of these methods over 12 months to find the most effective strategy.

Participant Groups

Group I: Package 16: Four WLM Components: RFV+HBRT+BTS+ACT Experimental Treatment 4 Interventions

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.

Group II: Package 10: Two WLM Components - RFV+BTS Active Control 2 Interventions

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

Group III: Package 11: Two WLM Components - RFV+HBRT Active Control 2 Interventions

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

Group IV: Package 1: No WLM Components Active Control 1 Intervention

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

Group V: Package 2: One WLM Component - BTS Active Control 1 Intervention

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

Group VI: Package 4: Two WLM Components - HBRT+BTS Active Control 2 Interventions

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

Group VII: Package 15: Three WLM Components - RFV+HBRT+ACT Active Control 3 Interventions

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

Group VIII: Package 6: Two WLM Components - BTS+ACT Active Control 2 Interventions

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

Group IX: Package 5: One WLM Component - ACT Active Control 1 Intervention

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

Group X: Package 12: Three WLM Components - RFV+HBRT+BTS Active Control 3 Interventions

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.

Group XI: Package 13: Two WLM Components - RFV+ACT Active Control 2 Interventions

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

Group XII: Package 14: Three WLM Components - RFV+BTS+ACT Active Control 3 Interventions

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

Group XIII: Package 3: One WLM Component - HBRT Active Control 1 Intervention

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

Group XIV: Package 8: Three WLM Components - HBRT+BTS+ACT Active Control 3 Interventions

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

Group XV: Package 9: One WLM Component - RFV Active Control 1 Intervention

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

Group XVI: Package 7: Two WLM Components - HBRT+ACT Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Long-term maintenance of weight loss in patients with obesity, particularly those with non-insulin dependent diabetes mellitus (NIDDM), remains a significant challenge despite initial weight reductions.

Implementing a continuous care model that includes ongoing professional support, skills training, social support, and exercise can significantly improve the chances of maintaining weight loss over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for improving maintenance of weight loss. Toward a continuous care model of obesity management. Perri, MG., Sears, SF., Clark, JE.[2022]

In a pilot study involving 45 obese patients with coronary heart disease, those who participated in a commercial weight management program (Weight Watchers) achieved a significant average weight loss of 5.8 kg, with 91% of participants losing weight.

After 14 weeks, 27 patients continued the program and experienced an even greater average weight loss of 9.1 kg, indicating that the program can be effective for long-term weight management in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS. Minneboo, M., Peters, RJ., Miller-Kovach, K., et al.[2015]

A comprehensive review of 497 randomized controlled trials involving nearly 100,000 adults with overweight or obesity highlighted that most self-management interventions focused on clinical outcomes and behavior adherence, but less on empowerment, quality of life, and patient satisfaction.

The most common techniques used in these interventions were information sharing, goal setting, and self-monitoring, often delivered face-to-face, indicating a need for more diverse approaches that include emotional support and remote techniques, especially for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management interventions for adults living with obesity to improve patient-relevant outcomes: An evidence map. Sunol, R., González-González, AI., Valli, C., et al.[2023]

Participants who followed a 12-month clustered campaign treatment schedule regained significantly less weight (0.35 kg) compared to those in a self-directed program (2.40 kg), indicating that structured support can help maintain weight loss after an initial treatment.

The clustered campaign approach allowed participants to maintain 87% of their weight loss, while those in the self-directed group maintained only 64%, highlighting the effectiveness of group-based support in preventing weight regain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Dutton, GR., Gowey, MA., Tan, F., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Early weight loss outcomes from a newly established hospital-affiliated specialized obesity care delivery model in Central Florida. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Strategies for improving maintenance of weight loss. Toward a continuous care model of obesity management. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Continuous care in the treatment of obesity: an observational multicentre study. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Translational research: bridging the gap between long-term weight loss maintenance research and practice. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Maximizing retention in long-term clinical trials of a weight loss agent: use of a dietitian support team. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Impact on weight and physical function of intensive medical weight loss in older adults with stage II and III obesity. [2019]

9. Ireland pubmed.ncbi.nlm.nih.gov

Self-management interventions for adults living with obesity to improve patient-relevant outcomes: An evidence map. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study). [2023]

11. England pubmed.ncbi.nlm.nih.gov

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. [2021]