Online Behavioral Obesity Treatment for Obesity

(FUEL Trial)

Overseen By Krystal Harvey, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: Weight loss medication

Disqualifiers: Pregnancy, Breastfeeding, Recent weight loss, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why individuals sometimes fail to adhere to dietary goals during weight loss programs. Researchers will use wearable sensors and smartphone apps to study various types of dietary lapses, such as overeating or consuming off-plan foods. Participants will engage in an online behavioral obesity treatment program (Gold-Standard Online Behavioral Obesity Treatment) to help identify patterns that can enhance future programs. Suitable candidates have a body mass index (BMI) of 25-50 and have not participated in a commercial weight loss program or experienced significant weight loss in the past six months. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could improve future weight loss programs.

Do I need to stop my current medications for this trial?

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 medication.

What prior data suggests that this online behavioral obesity treatment is safe?

Research shows that the top online program for treating obesity is generally safe for most people. Studies indicate that it aids in weight loss and reduces the risk of heart disease. This program uses smartphone and online tools to support weight loss by providing guidance and tracking progress.

Previous studies have found that online weight loss methods are both effective and safe. Participants in these programs often lose as much weight as those in traditional group settings. Additionally, this online approach offers greater convenience.

In terms of safety, this treatment doesn't involve drugs or surgery. It focuses on changing habits with the help of technology, so serious side effects are rare. The main goal is to help people maintain healthy eating and exercise routines, making it a well-tolerated option for those looking to manage their weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the gold-standard online behavioral weight loss treatment because it offers a versatile and accessible approach to managing obesity. Unlike traditional weight loss programs that often require in-person visits, this treatment is delivered entirely online, making it convenient for people with busy schedules or limited access to healthcare facilities. Additionally, it incorporates cutting-edge behavioral techniques to help individuals make sustainable lifestyle changes, potentially improving adherence and long-term outcomes compared to standard in-person interventions. This innovative approach could revolutionize how obesity is managed, offering personalized support without the need for physical appointments.

What evidence suggests that this online behavioral obesity treatment is effective for obesity?

Research has shown that online treatments for obesity can be effective. This trial will evaluate a gold-standard online behavioral obesity treatment. Studies have found that the Internet serves as a good alternative to in-person weight control programs. Although online methods might result in slightly less weight loss than traditional ones, they still help many people achieve significant results. Research also suggests that smartphones and online tools can aid weight loss by tracking habits and offering guidance. Overall, these online treatments provide a practical and accessible way to help people manage their weight. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

The FUEL trial is for adults aged 18-70 with a BMI between 25 and 50, who haven't lost more than 5% of their body weight recently, aren't on weight loss meds, not pregnant or breastfeeding, and haven't had weight loss surgery or an eating disorder (except Binge Eating Disorder).

Inclusion Criteria

Body mass index (BMI) between 25 and 50 kg/m-squared

Exclusion Criteria

I have had surgery to help me lose weight.

Has health problems for which weight loss or physical activity is contraindicated

Currently pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or telephone)

Baseline Assessment

Participants complete baseline questionnaires and a 1-week behavioral run-in with smartphone-based surveys and sensor wear

1 week

1 visit (virtual or in-person)

Treatment

Participants receive a 12-month online behavioral obesity treatment program

12 months

5 visits (in-person) at baseline, 3, 6, 12, and 18 months

Maintenance

Participants undergo a 6-month no-treatment follow-up period intended for weight maintenance

6 months

2 visits (in-person) at 12 and 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gold-Standard Online Behavioral Obesity Treatment

Trial Overview Participants will use a comprehensive online program to treat obesity for 18 months. They'll monitor their behavior using smartphone surveys and wearable sensors to help researchers understand dietary lapses during the program.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Gold-standard online behavioral weight loss treatment

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

An eight-week study involving 101 overweight participants showed that an internet-based behavioral therapy program (IBT) led to significantly greater weight loss (2.28 kg) compared to a standard email education program (0.74 kg).

Participants in the IBT group were also more successful in achieving a clinically significant weight loss of 5% of their initial body weight (17.6% vs. 2%), indicating that structured online interventions can be effective for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an Internet-Based Turkish Obesity Behavioral Therapy Program: A Randomized Study. Hepdurgun, C., Özalay, Ö., Pırıldar, Ş., et al.[2022]

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]

The Opt-IN study, involving 562 adults with obesity, identified an effective weight-loss treatment package that included 12 coaching calls, buddy training, and primary care provider reports, resulting in an average weight loss of 6.1 kg for a cost of $427 per person.

By systematically evaluating treatment components, the study found that increasing coaching calls from 12 to 24 did not enhance weight loss, allowing for a more cost-effective and efficient obesity treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. Spring, B., Pfammatter, AF., Marchese, SH., et al.[2021]

Internet treatment programs for overweight and obese individuals have been shown to be effective, resulting in weight losses of 4-7 kg over periods of 6 months to 1 year, based on various randomized trials.

These programs utilize methods such as e-mail support, automated messages, and chat rooms to enhance motivation and provide behavioral counseling, suggesting potential applications for similar approaches in treating substance use and misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A series of studies examining Internet treatment of obesity to inform Internet interventions for substance use and misuse. Tate, DF.[2010]

Online behavioral weight control programs have been effective in producing significant weight loss in adults, with newer programs showing even larger losses and higher consumer satisfaction.

Key features that may enhance engagement and outcomes in online obesity interventions include interactive website elements and real-time counselor support, though more research is needed to identify the most effective components and assess cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in internet-delivered, evidence-based weight control programs for adults. Krukowski, RA., West, DS., Harvey-Berino, J.[2021]

A study involving 154 overweight or obese patients showed that those referred to an automated Internet-based behavioral weight-loss intervention lost significantly more weight than those in an education-only control group, with average losses of 5.5 kg at 3 months and 5.4 kg at 6 months.

Over half of the participants in the Internet-based intervention achieved a clinically significant weight loss of 5% or more of their initial body weight, indicating the intervention's effectiveness in promoting weight control behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. Thomas, JG., Leahey, TM., Wing, RR.[2022]

A fully automated online behavioral weight-loss intervention offered to 1,721 patients in a primary care setting resulted in a significant average weight loss of 5.10% over 12 weeks, demonstrating its efficacy without the need for face-to-face counseling.

Engagement in the program was crucial; patients who consistently submitted their weights for all 12 weeks lost an average of 7.2% of their body weight, highlighting the importance of participation in achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic implementation of a fully automated online obesity treatment in primary care. Thomas, JG., Panza, E., Espel-Huynh, HM., et al.[2023]

A study involving 159 adults with overweight or obesity aims to optimize a smartphone-based intervention that delivers timely support to prevent dietary lapses during behavioral obesity treatment over a 6-month period.

Participants will receive tailored interventions based on their risk of dietary lapses, allowing for a more personalized approach to maintaining adherence to diet, with the goal of improving weight loss outcomes in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial. Goldstein, SP., Zhang, F., Klasnja, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6430643/

Comparison of Smartphone-based Behavioral Obesity ... Although mobile and online interventions appear to produce weight losses smaller than the 5–10% of initial body weight typically obtained via gold-standard ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05562427

Study Details | NCT05562427 | Program for Fully ... The online behavioral obesity treatment will automatically record which lessons have been viewed by the participant each week and the number of days in which ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420302950

Evaluation of intervention components to maximize ... This study will provide important information about intervention strategies that are useful for improving outcomes of online BLI.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3101104/

Internet Delivered Behavioral Obesity Treatment - PMC These results demonstrate that the Internet is a viable alternative to in-person treatment for the delivery and dissemination of a behavioral weight-control ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/13/2/e064394

Smartphone-supported behavioural weight loss treatment ... Comparison of smartphone-based behavioral obesity treatment with gold standard group treatment and control: a randomized trial. Obesity (Silver Spring) 2019;27: ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667368123000116

Artificial intelligence and obesity management: An ... AI may help clinicians who specialize in obesity medicine by offering interactive programming related to analyses of body composition imaging for more accurate ...

7. researchprotocols.org researchprotocols.org/2021/12/e33568/

Optimizing a Just-in-Time Adaptive Intervention to Improve ... Background: Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30779333/

Comparison of Smartphone-Based Behavioral Obesity ... Conclusions: Mobile online delivery of behavioral obesity treatment can achieve weight loss outcomes that are at least as good as those obtained via the more ...