Behavioral Strategies for Weight Loss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: Weight loss medications

Disqualifiers: Weight loss program, Bariatric surgery, Pregnancy, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of three online weight loss programs is most effective for adults with obesity. Each program employs different strategies to help participants modify their eating and exercise habits, focusing on either long-term benefits or avoiding long-term consequences. The study also examines adherence to the programs and any side effects, such as mood changes. It suits adults with a BMI (a measure of body fat) between 25 and 45 who have regular internet access and are not currently enrolled in another weight loss program. As an unphased trial, this study provides a unique opportunity to explore personalized weight loss strategies in a flexible, online setting.

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 taking weight loss medications.

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

Research has shown that weight loss programs focused on behavior, such as the PREVENT and PROMOTE programs, are generally safe and well-tolerated for adults with obesity. Studies have found that these programs can lead to significant weight loss without serious side effects. For instance, the U.S. Preventive Services Task Force (USPSTF) found that these programs can improve health and offer moderate benefits.

One study demonstrated that a program helped individuals with obesity and serious mental illness lose weight over 18 months, indicating that this approach is safe for diverse groups. Another study showed that these programs can improve health related to weight without major negative effects.

Overall, strategies like those in PREVENT and PROMOTE focus on changing eating habits and increasing physical activity. These methods are considered safe because they do not involve medication or surgery. Participants typically follow structured programs that guide them to make healthier lifestyle choices, reducing potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Strategies for Weight Loss trial because it explores fresh approaches to weight management that go beyond standard methods. The PROMOTE intervention is unique as it uses a future-focused cognitive strategy called Episodic Future Thinking (EFT) to highlight the long-term benefits of healthy choices, which is a novel twist on traditional behavior change techniques. On the other hand, the PREVENT intervention also utilizes EFT, but it emphasizes the long-term negative consequences of unhealthy behaviors, offering a different motivational angle. Both these strategies aim to enhance the effectiveness of online behavioral weight loss programs by adding a cognitive component that could lead to better adherence and results.

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

Research has shown that weight loss programs can be effective. In this trial, participants may join the PROMOTE program, which has helped about two-thirds of participants lose weight and maintain it after nine to ten months. Alternatively, participants might join the PREVENT program, which also has strong support; studies indicate it can lead to noticeable weight loss over 12 to 18 months. Both programs teach healthy eating and encourage increased physical activity, helping participants consider the long-term benefits or consequences of their choices. Overall, these methods have been linked to better control over eating habits and more successful weight management. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with obesity (BMI of 25-45) who have regular internet access. It's not for those in other weight loss programs, pregnant or nursing individuals, people planning to move away, or those with certain medical conditions without doctor approval.

Inclusion Criteria

Participants will have a BMI between 25 and 45 kg/m2

Participants will have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work

Exclusion Criteria

I have a health condition where losing weight could harm me.

Inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI

Individuals planning to relocate outside the area in the next 18 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Randomization

Participants complete a baseline assessment and are randomized to one of the three intervention arms

1 week

Treatment

Participants undergo a 12-month Internet-delivered weight loss program, including weekly lessons for 3 months, followed by monthly lessons, self-monitoring, and feedback

12 months

Weekly virtual lessons for 3 months, monthly virtual lessons thereafter

Mid-Treatment Assessment

Participants complete assessments and refresher workshops at 3 and 6 months during the treatment phase

6 months

Assessments at 3 and 6 months

Follow-up

Participants are monitored for weight change and other outcomes 6 months after treatment completion

6 months

Assessment at 18 months

What Are the Treatments Tested in This Trial?

Interventions

• PREVENT Behavioral Weight Loss Intervention
• PROMOTE Behavioral Weight Loss Intervention
• Standard Behavioral Weight Loss Intervention

Trial Overview The study compares three online weight loss programs: STANDARD Behavioral Weight Loss Intervention and two others focusing on different cognitive strategies (PREVENT and PROMOTE). Participants will follow a year-long program with assessments at various stages.

How Is the Trial Designed?

Group I: PROMOTE Experimental Treatment 1 Intervention

This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and activity daily via a study website. Additionally, PROMOTE uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term benefits of healthy choices. Participants will receive cognitive training in PROMOTE prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and activity behaviors. These lessons and individualized feedback to participants are framed according to PROMOTE (i.e., focusing on achieving long-term benefits of healthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month), and feedback.

Group II: PREVENT Experimental Treatment 1 Intervention

This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Additionally, PREVENT uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term negative consequences of unhealthy choices. Participants will receive training in PREVENT strategies prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants are framed according to PREVENT (i.e., focusing on avoiding long-term consequences of unhealthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training session at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.

Group III: STANDARD Behavioral Active Control 1 Intervention

This is a 12-month Internet-delivered behavioral weight loss (iBWL) program that has been used in numerous studies and is currently considered our 'standard' treatment. Participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Participants will have a training session prior to beginning iBWL to learn about the website and their specific weight-related goals. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants incorporate key BWL strategies. Participants will then have a 'refresher' training session at 3 months to discuss standard behavioral weight loss strategies and help control for contact across arms. For the remainder of the program (months 4-12) participants will have monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

Brown University

Collaborator

Trials

480

Recruited

724,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

Combining diet therapy, exercise, and behavioral therapy is essential for effective weight reduction and long-term maintenance in obese patients, as these methods help correct energy balance.

Specific behavioral strategies like self-monitoring and stress management are crucial for sustaining weight loss, with daily weight charting being particularly effective for reinforcing these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Behavioral therapy for obesity]. Yoshimatsu, H.[2011]

A behavioral modification weight-reduction program for 80 low socioeconomic status women resulted in a mean weight loss of 4.6% of their ideal body weight, which was statistically superior to the 0.9% weight loss in the control group receiving individualized counseling.

Thirteen percent of participants in the behavioral modification group maintained a weight loss of 20 pounds or more after one year, compared to 6.4% in the control group, indicating that group-oriented behavioral therapy may be effective in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral modification in a weight-reduction program. Holm, RP., Taussig, MT., Carlton, E.[2022]

Only about 5% of people on weight loss programs achieve lasting weight reduction, highlighting the challenges of effective weight management.

Successful weight loss strategies often combine cognitive-behavioral techniques, social-contextual approaches, and biophysical methods like dietary restriction and exercise, allowing for tailored interventions based on individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for weight control success in adults. Keller, C., Oveland, D., Hudson, S.[2007]

Current guidelines recommend a combination of diet, exercise, and behavior therapy for managing obesity, which can lead to an average weight loss of about 10% of initial body weight, but maintaining this weight loss is challenging.

The review suggests that shifting from a focus on behavior change to cognitive change may enhance the long-term effectiveness of weight management programs, although more research is needed to compare the long-term outcomes of these different approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy and cognitive-behavioral therapy of obesity: is there a difference? Fabricatore, AN.[2007]

In a study of 106 patients with type II diabetes, changes in eating behavior strategies were linked to weight loss, indicating that adopting specific strategies can lead to better outcomes.

Key strategies for weight loss included eating weight-loss-friendly foods, keeping a food diary, refusing food from others, and knowing when to stop eating; however, many patients struggled to maintain these behaviors over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of changes in eating behavior and weight loss in type II diabetic patients. Which behaviors to change. Guare, JC., Wing, RR., Marcus, MD., et al.[2019]

A randomized controlled trial with 95 participants showed that a prevention-focused strategy in an internet-delivered behavioral weight-loss intervention led to a significant weight loss of 6.6% and increased self-control compared to standard and promotion-focused strategies.

Participants using the prevention approach not only lost more weight but also demonstrated improved self-control, highlighting the effectiveness of focusing on the negative consequences of unhealthy choices in weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing prevention and promotion cognitive strategies in a behavioral weight-loss intervention. Demos McDermott, KE., Leblond, TL., Dunsiger, SI., et al.[2022]

In a study of 80 obese women, those who participated in problem-solving therapy (PST) after initial behavioral treatment achieved significantly greater long-term weight loss compared to those who only received standard behavioral treatment (BT).

Participants in the PST group had a higher percentage of clinically significant weight loss (10% or more) at 35%, compared to just 6% in the BT group, highlighting the potential effectiveness of PST as an extended intervention for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapse prevention training and problem-solving therapy in the long-term management of obesity. Perri, MG., Nezu, AM., McKelvey, WF., et al.[2022]

In a clinical trial with 195 participants, the MAINTAIN strategy, which provided additional support later in the intervention, resulted in significantly greater weight loss over 18 months compared to standard behavioral weight loss programs (SBWP) and the ADOPT strategy.

The MAINTAIN group not only lost more weight but also showed improved fitness levels, suggesting that timing of additional support in weight loss interventions can enhance both weight loss and physical fitness outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-based physical activity interventions for weight loss: a randomized trial. Jakicic, JM., Rickman, AD., Lang, W., et al.[2021]

In a study involving 468 adults with obesity, participants who switched to portion-controlled meals (PCM) after being identified as suboptimal responders to standard behavioral weight loss treatment (SBT) lost more weight at 6 months compared to those who switched to acceptance-based treatment (ABT), although the difference was not statistically significant.

Identifying suboptimal responders as early as Session 3 of treatment led to greater weight loss in those switched to PCM compared to those identified later, suggesting that early intervention may enhance the effectiveness of weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. Sherwood, NE., Crain, AL., Seburg, EM., et al.[2022]

A weight maintenance intervention (MI) significantly improved weight loss maintenance in obese adults compared to those who only participated in a behavioral weight loss program (BWLP) without additional support, with 38 participants completing the six-month follow-up.

Participants in the MI group not only maintained their weight loss better but also showed improvements in physical activity and dietary habits, suggesting that modifying personal environments to reduce unhealthy cues can aid long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking control of your personal eating and exercise environment: a weight maintenance program. Carels, RA., Konrad, K., Young, KM., et al.[2021]

Behavioral treatment can effectively lead to a 10% weight loss, which is significant enough to improve health outcomes for patients.

Maintaining weight loss is difficult, but long-term success can be enhanced by increasing patient-provider contact, encouraging physical activity, and combining lifestyle changes with medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of obesity. Butryn, ML., Webb, V., Wadden, TA.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702878

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss maintenance interventions are of moderate benefit. The USPSTF found adequate ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30326501/

Updated Evidence Report and Systematic Review for the ... Compared with controls, participants in behavior-based interventions had greater mean weight loss at 12 to 18 months (-2.39 kg [95% CI, -2.86 to -1.93]; 67 ...

3. odphp.health.gov odphp.health.gov/healthypeople/tools-action/browse-evidence-based-resources/weight-loss-prevent-obesity-related-morbidity-and-mortality-adults-behavioral-interventions

Weight Loss to Prevent Obesity-Related Morbidity and ... These interventions use healthy eating and increased physical activity to help people achieve or maintain weight loss of at least 5 percent.

4. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... We demonstrated that multicomponent nutrition and physical activity interventions of 6 months or less can achieve weight loss by the end of the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11884964/

The impact of behavioral weight management interventions on ... We found evidence to suggest that interventions improved uncontrolled eating, external eating, susceptibility to hunger, restraint and intuitive eating at ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30326502/

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss maintenance interventions are of moderate benefit. The USPSTF found adequate ...

7. aafp.org aafp.org/pubs/afp/issues/2019/0415/od1.html

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss interventions in adults with obesity can lead to clinically significant improvements in ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702877

Behavioral and Pharmacotherapy Weight Loss ... Objective To systematically review evidence on benefits and harms of behavioral and pharmacotherapy weight loss and weight loss maintenance ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1214530

A Behavioral Weight-Loss Intervention in Persons with ... A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness.

10. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/obesity-in-adults-interventions

Weight Loss to Prevent Obesity-Related Morbidity and ... The USPSTF found adequate evidence that behavior-based weight loss interventions in adults with obesity can lead to clinically significant improvements in ...