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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,481 Previous Clinical Trials
17,516,697 Total Patients Enrolled
12 Trials studying Weight Loss
1,652 Patients Enrolled for Weight Loss
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,334,909 Total Patients Enrolled
103 Trials studying Weight Loss
19,041 Patients Enrolled for Weight Loss
Michele L Patel, PhDPrincipal InvestigatorStanford University

Media Library

Core behavioral weight loss intervention Clinical Trial Eligibility Overview. Trial Name: NCT05249465 — N/A
Weight Loss Research Study Groups: Condition 5, Condition 7, Condition 6, Condition 2, Condition 3, Condition 1, Condition 4, Condition 8
Weight Loss Clinical Trial 2023: Core behavioral weight loss intervention Highlights & Side Effects. Trial Name: NCT05249465 — N/A
Core behavioral weight loss intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05249465 — N/A
Weight Loss Patient Testimony for trial: Trial Name: NCT05249465 — N/A
~50 spots leftby Jun 2025