Digital Health Weight Loss Strategies for Weight Loss

Overseen By Lisa G Rosas, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Weight loss drugs, Steroids, Antipsychotics

Disqualifiers: Pregnancy, Breastfeeding, Mental health, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests digital tools for weight loss by having participants track their diet, steps, and body weight. The goal is to determine which combination of these tracking strategies works best over six months. Participants receive guidance through goal setting, behavioral lessons, and personalized feedback, all from home. It suits adults with a body mass index (BMI) between 25 and 45 who want to lose weight using behavioral strategies and have a smartphone to use the app. As an unphased trial, this study offers a unique opportunity to explore innovative weight loss strategies in a supportive, home-based 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 using a weight loss medication or if weight loss might be impacted by a condition or medication.

What prior data suggests that these digital health strategies for weight loss are safe?

Research has shown that digital health tools for weight loss are generally safe. In past studies, participants used these tools without serious side effects. Most found them easy to use and experienced positive outcomes, such as weight loss. No major reports of harm have emerged from using these tools.

The main weight loss program being tested involves setting goals, learning new habits, and receiving feedback. These methods have proven safe and are usually well-received. Participants in similar studies have successfully used these methods to lose weight.

Overall, strong evidence supports the safety of the treatment methods for potential trial participants. They can expect a supportive experience with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital health weight loss strategies because they integrate technology with traditional behavioral interventions. Unlike standard weight loss treatments that often rely heavily on in-person counseling or medication, these strategies use digital tracking of weight, steps, and diet. This allows for a more personalized and data-driven approach to weight management. The potential for real-time feedback and the convenience of digital methods could make weight loss efforts more effective and sustainable for individuals. By utilizing technology, these strategies aim to enhance engagement and adherence, which are key challenges in traditional weight loss programs.

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

This trial will evaluate various digital health strategies for weight loss. Research has shown that digital tools for tracking weight, diet, and exercise can significantly aid in weight loss. Participants will be assigned to different groups, each using a combination of these tools. Studies have found that individuals using these tools often lose more than 5% of their body weight, a significant change. Monitoring food intake, physical activity, and weight typically leads to better weight control. Setting goals and receiving feedback are key strategies that enhance the effectiveness of these digital tools. Overall, using these strategies together can lead to more successful weight loss. ^{3 6 7 8 9}

Who Is on the Research Team?

Michele L Patel, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Adults aged 18+ with a BMI of 25.0 to 45.0 kg/m^2, owning a smartphone and willing to use an app for weight loss are eligible. They must speak English, have email access, and be interested in losing weight through behavioral strategies without using weight loss medications or having had bariatric surgery.

Inclusion Criteria

Body mass index (BMI) 25.0 to 45.0 kg/m^2

I want to lose weight by changing my behaviors.

English language proficiency

Exclusion Criteria

I cannot do moderate exercise like brisk walking.

I have a condition or take medication that makes losing weight difficult or not recommended.

I have not been hospitalized for a mental health condition in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screening questionnaire and remote session

Treatment

Participants receive a 6-month digital health intervention for weight loss, including goal setting, behavioral lessons, action plans, and tailored feedback. Depending on the group, participants track dietary intake, steps, and/or body weight.

6 months

All tasks conducted remotely

Follow-up

Participants are monitored for weight change and engagement in self-monitoring strategies after the intervention

6 months

Remote assessments at baseline, 1 month, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Core behavioral weight loss intervention
• Self-monitoring diet
• Self-monitoring steps
• Self-monitoring weight

Trial Overview

The trial is testing three digital self-monitoring methods for weight loss: tracking diet, steps, and body weight over six months. Participants will receive core treatment remotely and may also get an orientation video to see if it helps with staying in the study.

How Is the Trial Designed?

Group I: Condition 8 Experimental Treatment 4 Interventions

Core + Track Weight + Track Steps + Track Diet

Group II: Condition 7 Experimental Treatment 3 Interventions

Core + Track Steps + Track Diet

Group III: Condition 6 Experimental Treatment 3 Interventions

Core + Track Weight + Track Diet

Group IV: Condition 5 Experimental Treatment 3 Interventions

Core + Track Weight + Track Steps

Group V: Condition 4 Experimental Treatment 2 Interventions

Core + Track Diet

Group VI: Condition 3 Experimental Treatment 2 Interventions

Core + Track Steps

Group VII: Condition 2 Experimental Treatment 2 Interventions

Core + Track Weight

Group VIII: Condition 1 Experimental Treatment 1 Intervention

Core Only

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The study involved 809 Brazilian adults with overweight and obesity, using the Behaviour Change Wheel (BCW) framework to develop a web platform aimed at promoting weight loss through targeted behavior changes over a 24-week intervention.

The platform's functionalities were categorized based on the BCW components, showing that motivation-driven features were accessed the most, indicating their potential effectiveness in engaging users, while capability-driven features had lower usage, suggesting areas for improvement in behavior diagnosis and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS". Beleigoli, AM., Andrade, AQ., Diniz, MFH., et al.[2022]

In a 6-month trial involving 153 adults with overweight and obesity, a personalized digital weight loss program (WeightWatchers) led to an average weight loss of 5.05% from baseline, with 51% of participants achieving at least a 5% weight loss, indicating its efficacy.

Participants reported high satisfaction and engagement with the program, with significant improvements in various health-related behaviors, including increased fruit and vegetable intake, physical activity, and better sleep quality, suggesting the program's positive impact on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. Pagoto, S., Xu, R., Bullard, T., et al.[2023]

The study developed a digital behavior change intervention called eCHANGE, which integrates persuasive system design (PSD) principles and behavior change techniques (BCTs) to support long-term weight maintenance, based on input from 45 stakeholders including end users and health care providers.

Seventeen key design features were identified and grouped into four main components of the intervention, emphasizing personalization, self-monitoring, and social support, which are crucial for engaging users and promoting sustainable behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Persuasive System Design Principles and Behavior Change Techniques in Digital Interventions Supporting Long-term Weight Loss Maintenance: Design and Development of eCHANGE. Asbjørnsen, RA., Hjelmesæth, J., Smedsrød, ML., et al.[2022]

The study will involve adults aged 18 to 70 with overweight or obesity, using digital tools for self-monitoring in a 24-month behavioral weight loss program aimed at achieving and maintaining a 10% weight loss.

It will explore the effectiveness of different data sharing partnerships (with coaches, group members, and friends/family) on long-term weight loss, potentially revealing how these interactions can enhance weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. Miller, NA., Ehmann, MM., Hagerman, CJ., et al.[2023]

This pilot trial involves 80 overweight or obese rural men aged 40-69 and aims to assess the feasibility and acceptability of two mobile applications for weight loss over a 6-month period.

The study will compare a more comprehensive intervention (MT+) that includes a self-monitoring app, discussion group, text support, and Wi-Fi scale against a basic app (MT), to evaluate their effectiveness in promoting weight loss and improving dietary and physical activity behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial. Eisenhauer, CM., Brito, FA., Yoder, AM., et al.[2023]

In a study of 11,252 participants using the Noom mobile app, higher engagement in activities like logging meals and reading articles was significantly associated with achieving moderate (5-10% weight loss) and high (10% or greater weight loss) outcomes compared to stable weight.

The relationship between engagement and weight loss outcomes was consistent over time, indicating that sustained participation in the program is crucial for long-term weight management success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Weight Loss Outcomes and Engagement in a Mobile Behavioral Change Intervention: Retrospective Analysis. Carey, A., Yang, Q., DeLuca, L., et al.[2022]

The NoHoW project developed a digital toolkit aimed at promoting long-term weight management, tested in an 18-month randomized controlled trial involving adults who had lost at least 5% of their body weight in the previous year.

The toolkit included 34 sessions across 15 modules, utilizing web-based tools and digital tracking devices to target weight, physical activity, and dietary behaviors, demonstrating a systematic approach to behavior change that could enhance weight loss maintenance strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study. Marques, MM., Matos, M., Mattila, E., et al.[2022]

The SMART intervention, which utilized social and mobile technologies for weight loss, showed significant short-term weight loss at 6 and 12 months among young adults, but did not maintain this effect at 24 months, indicating limited long-term efficacy.

While the intervention was generally safe, there was one serious adverse event (gallstones) linked to rapid weight loss, highlighting the need for careful monitoring in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial. Godino, JG., Merchant, G., Norman, GJ., et al.[2022]

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