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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best combination of strategies for maintaining weight loss. Participants will try different combinations of four methods: limiting food variety, home exercises, buddy support, and workshops on managing weight-related feelings. The goal is to determine which combination effectively keeps weight off without excessive hassle or cost. Suitable candidates have struggled with maintaining weight loss and can identify a buddy for support. As an unphased trial, this study provides a unique opportunity to explore personalized strategies for long-term weight management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the methods used in this study are generally safe for participants.

For Reduced Food Variety, studies suggest it can help treat obesity by lowering calorie intake. Although specific safety data is lacking, its common use as a diet approach indicates it is usually well-tolerated.

Buddy Training and Support often features in weight management programs. While it might not directly cause weight loss, it safely helps maintain motivation and weight.

Home-based Resistance Training is safe and effective for building strength and improving health. Research confirms it can be done safely at home, benefiting heart health and muscle strength.

Acceptance and Commitment Therapy (ACT) has been safely used in studies for obesity and weight management. It helps individuals manage difficult thoughts and feelings about weight control.

Overall, these methods are generally safe and widely used in weight management. Participants can feel confident knowing these approaches are well-tested. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the interventions being tested for weight loss maintenance because they explore a combination of strategies that could enhance long-term success. Unlike standard weight loss programs that often focus on diet and exercise separately, this approach incorporates unique elements like Reduced Food Variety (RFV), Buddy Training and Support (BTS), Home-based Resistance Training (HBRT), and Acceptance and Commitment Therapy (ACT) Workshops. By integrating these components, the interventions aim to tackle weight maintenance from multiple angles, potentially offering more comprehensive and sustainable results. This multidimensional approach could address the psychological, social, and physical aspects of weight loss, making it a promising strategy for those struggling to keep off the weight they've lost.

What evidence suggests that this trial's treatments could be effective for weight loss maintenance?

Research has shown that eating fewer types of high-calorie foods can help control food intake, though it might not always lead to long-term weight loss. In this trial, participants in different arms will receive various combinations of interventions. Some will receive support through a buddy or support group, which can make it easier to maintain healthy habits. Others will engage in resistance exercises at home to keep muscles strong while losing weight, which is important for maintaining weight loss. Acceptance and Commitment Therapy (ACT) is another component being tested, as it can help manage difficult thoughts about weight and has been effective in supporting weight loss. Each of these strategies offers benefits, and using them together might be the best way to sustain weight loss. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9918584/

Effectiveness of acceptance and commitment therapy on ... ACT was found to be effective in improving weight loss in terms of BMI (k = 6, WMD = − .50, 95% CI = − .90; − .11, t = − 3.25, p = .20, I 2

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423000149

Protocol of the WeLNES full scale randomized controlled trial Results showed that a greater proportion of ACT participants (24%) achieved ≥10% weight loss as compared to SBT (13%) at 6 months (OR = 2.45; 95% CI: 0.65, 9.23) ...

3. link.springer.com link.springer.com/article/10.1007/s13679-025-00634-y

Acceptance and Commitment Therapy for Obesity Current data indicate that ACT-based interventions produce comparable, or, in some cases, superior weight loss compared to standard behavioral interventions.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9015891/

Study Protocol for a Randomized Controlled Trial ... Although 24-month weight loss in ACT was not statistically different from SR (−4.18%, SE=1.32), ACT showed greater treatment engagement and greater improvements ...

5. sites.brown.edu sites.brown.edu/publichealthjournal/2024/03/17/analyzing-technology-supported-acceptance-and-commitment-therapy-for-obesity/

Analyzing Technology-Supported Acceptance and ... Overall, ACT has been found to be effective in treating psychological aspects of obesity and partially in addressing weight loss.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7497453/

The Effects of Acceptance and Commitment Therapy (ACT) ... We investigated whether acceptance and commitment therapy (ACT), targeted on psychological flexibility (PF), influences inflammation and stress biomarkers.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2212144724001078

An acceptance and commitment therapy and mindfulness ... This study suggests that an ACT and mindfulness-based group intervention could produce improvements in the impact of weight on quality of life.

8. withpower.com withpower.com/trial/phase-obesity-5-2023-74ac3

Acceptance and Commitment Therapy Workshop for Obesity Acceptance and Commitment Therapy (ACT) has been used safely in various studies for different conditions, including obesity and weight management, without any ...

9. jmir.org jmir.org/2022/8/e39182/

The Effects of Internet-Based Acceptance and Commitment ... This meta-analysis found that iACT had a medium effect on psychological flexibility and small effects on mindfulness, valued living, and cognitive defusion.

10. researchprotocols.org researchprotocols.org/2016/4/e180/

Teaching Intuitive Eating and Acceptance and Commitment ... This pilot study investigated the usage, acceptability, and feasibility of “Mind, Body, Food,” a Web-based weight gain prevention intervention prototype.