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Smartphone-Based Dietary Support for Obesity

N/A
Recruiting
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-70
Able to walk 2 city blocks without stopping
Must not have
Has history of bariatric surgery
Currently taking weight loss medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-months, 6-months

Summary

This trial is designed to find the best way to use a smartphone-based app to help prevent people from falling off their diet, which can help with obesity treatment.

Who is the study for?
This trial is for adults aged 18-70 with a BMI of 25-50 and at least one cardiovascular risk factor like prediabetes, type 2 diabetes, high cholesterol, or hypertension. They must be able to walk two blocks without stopping and not be in another weight loss program or have conditions that affect study participation.
What is being tested?
The trial tests a smartphone-based intervention to prevent dietary lapses during obesity treatment. It uses daily surveys, machine learning for lapse risk assessment, and various interventions when there's a high risk of lapsing. The effectiveness of these interventions will be compared.
What are the potential side effects?
Since the interventions involve behavioral treatments like self-efficacy enhancement and education rather than medications, traditional side effects are not expected; however, participants may experience stress or frustration if they struggle with adherence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I can walk 2 city blocks without needing to stop.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had weight loss surgery in the past.
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I am currently on medication for weight loss.
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I have experienced chest pain or fainted in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-months, 6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-months, 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
Dietary Lapses
Secondary study objectives
Objectively-measured Eating Duration
Objectively-measured Eating Frequency
Objectively-measured Eating Rate
+1 more
Other study objectives
Height
JITAI Satisfaction
JITAI Tailoring Variable: Advertisements
+19 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Self-regulationExperimental Treatment2 Interventions
Theory-driven intervention focused on providing skills to increase self-regulation
Group II: Self-efficacyExperimental Treatment2 Interventions
Theory-driven intervention focused on providing skills to increase self-efficacy for following dietary goals
Group III: MotivationExperimental Treatment2 Interventions
Theory-driven intervention focused on providing skills to increase motivation for following dietary goals
Group IV: Enhanced EducationExperimental Treatment2 Interventions
Theory-driven intervention focused on providing information about dietary quality and goals
Group V: Generic Risk AlertActive Control2 Interventions
A notification to alert participant of lapse risk, no additional intervention provided
Group VI: No InterventionPlacebo Group1 Intervention
No notification or intervention is delivered to the participant during lapse risk
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Education
2011
Completed Phase 3
~320
Self-Efficacy
2009
N/A
~1220
Motivation
2021
N/A
~1610

Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor
245 Previous Clinical Trials
37,739 Total Patients Enrolled
75 Trials studying Obesity
14,937 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,792,138 Total Patients Enrolled
254 Trials studying Obesity
211,261 Patients Enrolled for Obesity

Media Library

Enhanced Education Clinical Trial Eligibility Overview. Trial Name: NCT04784585 — N/A
Obesity Research Study Groups: Generic Risk Alert, Self-efficacy, Motivation, Enhanced Education, Self-regulation, No Intervention
Obesity Clinical Trial 2023: Enhanced Education Highlights & Side Effects. Trial Name: NCT04784585 — N/A
Enhanced Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784585 — N/A
~39 spots leftby Dec 2025
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