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

Trial Summary

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 data supports the effectiveness of the Online Behavioral Obesity Treatment for weight loss?

Research shows that online behavioral obesity treatments can help people lose 4-7 kg (about 9-15 pounds) over 6 months to a year when support is provided through email, automated messages, or chat rooms. These programs have been shown to be effective in helping people lose weight and maintain it over time. ^{1 2 3 4 5}

Is online behavioral obesity treatment safe for humans?

The research on online behavioral obesity treatment shows it is generally safe for humans, as it has been used successfully in various studies to help people lose weight without reported safety concerns. ^{1 2 4 6 7}

How is the Gold-Standard Online Behavioral Obesity Treatment different from other obesity treatments?

The Gold-Standard Online Behavioral Obesity Treatment is unique because it is delivered entirely online, making it more accessible and potentially more engaging with features like interactive websites and counselor contact. It focuses on behavioral changes to support weight loss and is designed to be cost-effective, aiming to maximize weight loss for less than $500. ^{1 2 6 7 8}

What is the purpose of this trial?

This project seeks to better understand dietary lapses (instances of nonadherence to dietary goals), a major cause of poor outcomes during behavioral obesity treatment (BOT). Investigators propose to conduct multimodal real-time assessment of behavioral, psychosocial, and contextual characteristics to uncover lapse phenotypes (i.e., meaningful clusters of lapse behaviors, such as lapsing via overeating vs. lapsing via eating an off-plan food). Using wearable sensors and a smartphone-based assessment platform, this research will identify latent characteristics underlying different phenotypes of dietary lapses reported by individuals who are participating in an online BOT. This study will also evaluate how these emerging lapse phenotypes vary over time, between individuals, and within individuals. Such information will ultimately help the field understand how best to reduce lapses in future treatments (e.g., how much to personalize future interventions for lapse vs. generalizability of lapse phenotypes across individuals). Therefore, this study has three goals. First, investigators aim to establish lapse phenotypes by identifying clusters of behavioral, psychosocial, contextual and individual-level factors (e.g., sex, race) that differentiate lapse behaviors during weight loss and maintenance. Second, the investigators aim to test the association of lapse phenotypes with energy intake and weight change during weight loss and maintenance to determine which lapse phenotypes have the greatest impact on BOT outcomes (e.g. personal, environmental, and behavioral factors). Lastly, investigators aim to evaluate individual variability in the occurrence of lapse phenotypes during weight loss and maintenance to determine the generalizability of lapse phenotypes across individuals. Participants will be recruited through various methods including advertisements in local media, targeted online advertising, advertisements in medical and minority communities, and direct mailers. All participants will receive a well-established online BOT program for 12 months, with a 6-month maintenance period, for a total study participation of 18 months. In conjunction, they will complete 14-day monitoring periods (at baseline, 3 months, 6 months, 12 months, and 18 months) consisting of: 1) repeated daily smartphone surveys to assess personal, environmental, and behavioral factors, including automatic capture of geographic location; 2) wearing two wrist-based sensor devices to passively capture physical activity, sleep, and eating behaviors; and 3) completing telephone-based 24-hour dietary recalls to assess overall energy intake. Weight will be measured at all visits to the research center.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Canada 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Pragmatic implementation of a fully automated online obesity treatment in primary care. [2023]

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

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]

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

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. [2022]

6. Turkey pubmed.ncbi.nlm.nih.gov

Testing an Internet-Based Turkish Obesity Behavioral Therapy Program: A Randomized Study. [2022]

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

Recent advances in internet-delivered, evidence-based weight control programs for adults. [2021]

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

A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. [2021]