What is the mechanism of action of this treatment?

Common weight loss treatments, particularly those involving self-monitoring strategies through digital health tools, work primarily through behavioral modification. By tracking dietary intake, physical activity, and body weight, patients become more aware of their habits and can make informed changes. This self-monitoring increases accountability, helps set realistic goals, and provides tailored feedback, all of which are essential for maintaining motivation and achieving long-term weight loss success. The digital format ensures continuous engagement and support, making it easier for patients to adhere to their weight loss plans.

What side effects are associated with this type of intervention?

Behavioral modification through digital health tools for weight loss, such as tracking dietary intake, physical activity, and body weight, generally have minimal side effects. However, they can include increased anxiety or stress from constant self-monitoring, potential for obsessive behaviors around food and exercise, and frustration if weight loss goals are not met. Additionally, users may experience screen fatigue or technical difficulties, which can affect adherence to the program.

What prior FDA approvals exist?

The FDA has approved several medications for weight loss, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These medications work through various mechanisms such as appetite suppression and fat absorption inhibition. In addition to pharmacotherapy, behavioral modification strategies, including digital health tools for self-monitoring dietary intake, physical activity, and body weight, have been studied for their effectiveness in weight loss. These digital interventions aim to enhance adherence to weight loss programs by providing real-time feedback and personalized support.

What other types of research exist?

Promising, novel alternatives to self-monitoring strategies for weight loss patients include: 1) Mobile phone text messaging and app-based interventions, which provide real-time support and personalized feedback. 2) Internet-based interventions, which offer structured programs and community support. 3) Social network interventions, such as Tweet2Quit, which leverage peer support and accountability. 4) Acceptance and Commitment Therapy (ACT), delivered face-to-face or via telehealth, focusing on psychological flexibility and commitment to behavior change. 5) Mindfulness and yoga-based interventions, which address emotional eating and stress management.

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Digital Health Weight Loss Strategies for Weight Loss

N/A

Recruiting

Led By Michele L Patel, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Inability to engage in moderate forms of physical activity akin to brisk walking (assessed by the Physical Activity Readiness Questionnaire)

Hospitalization for a mental health condition in the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a non-medical intervention focusing on behavior changes through digital tools, there aren't typical side effects like those seen with medication; however, participants might experience fatigue or stress from regular self-monitoring.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot do moderate exercise like brisk walking.

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

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I am currently taking medication to lose weight.

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I have had or am planning to have weight loss surgery.

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I have lost 10 or more pounds in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body weight change from baseline to 6 months

Secondary study objectives

BMI change from baseline to 6 months

Body weight from baseline to 1 month

Body weight from baseline to 3 months

+6 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Condition 8Experimental Treatment4 Interventions

Core + Track Weight + Track Steps + Track Diet

Group II: Condition 7Experimental Treatment3 Interventions

Core + Track Steps + Track Diet

Group III: Condition 6Experimental Treatment3 Interventions

Core + Track Weight + Track Diet

Group IV: Condition 5Experimental Treatment3 Interventions

Core + Track Weight + Track Steps

Group V: Condition 4Experimental Treatment2 Interventions

Core + Track Diet

Group VI: Condition 3Experimental Treatment2 Interventions

Core + Track Steps

Group VII: Condition 2Experimental Treatment2 Interventions

Core + Track Weight

Group VIII: Condition 1Experimental Treatment1 Intervention

Core Only

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common weight loss treatments, particularly those involving self-monitoring strategies through digital health tools, work primarily through behavioral modification. By tracking dietary intake, physical activity, and body weight, patients become more aware of their habits and can make informed changes. This self-monitoring increases accountability, helps set realistic goals, and provides tailored feedback, all of which are essential for maintaining motivation and achieving long-term weight loss success. The digital format ensures continuous engagement and support, making it easier for patients to adhere to their weight loss plans.

Exploring women's experiences of treatment for binge eating disorder: Methylphenidate vs. cognitive behavioural therapy.Treatment of compulsive exercise in eating disorders and muscle dysmorphia: protocol for a systematic review.Meta-analysis of the efficacy of psychological and medical treatments for binge-eating disorder.