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

176 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests different ways of using digital tools to track diet, steps, and weight for weight loss in overweight or obese adults. People will use these methods to keep track of their eating and activity over several months. The goal is to find the best combination of tracking methods to help people lose weight effectively.

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 data supports the effectiveness of this treatment for weight loss?

Research shows that digital tools for self-monitoring diet, steps, and weight can help people lose weight by encouraging behavior change. Studies found that the more people engage with these digital programs, like logging meals or reading articles, the more weight they tend to lose. ^{1 2 3 4 5}

Is digital self-monitoring for weight loss safe for humans?

The research does not specifically address safety concerns, but digital self-monitoring tools for weight loss, such as tracking diet and physical activity, are generally considered safe for human use. ^{2 5 6 7 8}

How is the Core behavioral weight loss intervention treatment different from other weight loss treatments?

The Core behavioral weight loss intervention is unique because it uses digital health strategies to support long-term weight loss by combining persuasive system design principles and behavior change techniques. This approach allows for personalized, scalable, and cost-effective interventions that can be delivered widely through digital platforms, unlike traditional in-person methods. ^{2 3 4 9 10}

Research Team

Michele L Patel, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

The Relationship Between Weight Loss Outcomes and Engagement in a Mobile Behavioral Change Intervention: Retrospective Analysis. [2022]

2. Canada 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS". [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. [2023]

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

Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Dietary and herbal supplements for weight loss: assessing the quality of patient information online. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Racial and ethnic minority enrollment in randomized clinical trials of behavioural weight loss utilizing technology: a systematic review. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study. [2022]

10. England 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. [2022]