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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
Able to walk 2 city blocks without stopping
Age 18-70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-months, 6-months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can walk 2 city blocks without needing to stop.
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I am between 18 and 70 years old.
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I have been diagnosed with a condition that increases my risk for heart disease.
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I can walk 2 city blocks without needing to stop.
Select...
I am between 18 and 70 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dietary Lapses
Secondary outcome measures
Objectively-measured Eating Duration
Objectively-measured Eating Frequency
Objectively-measured Eating Rate
+1 more
Other outcome measures
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
Self-Efficacy
2009
N/A
~1220
Motivation
2021
N/A
~1610
Enhanced Education
2011
Completed Phase 3
~320

Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor
238 Previous Clinical Trials
37,446 Total Patients Enrolled
75 Trials studying Obesity
14,981 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,598 Total Patients Enrolled
249 Trials studying Obesity
205,537 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many applicants are accepted into this research program?

"Yes, according to clinicaltrials.gov's data, this research is currently gathering participants. The trial was first made available on October 26th 2021 and has since been amended on May 6th 2022. This study requires 159 volunteers from 1 site for completion."

Answered by AI

Does this research endeavor have any open enrollment?

"The clinicaltrials.gov website reveals that, as of May 6th 2022, this medical experiment is searching for additional candidates. The trial was originally made available on October 26th 2021."

Answered by AI

How can I become a participant in this research?

"This research is enrolling 159 individuals, aged 18-70, who have a body mass index (BMI) between 25 and 50 kg/m-squared, and can cover 2 city blocks on foot without interruption."

Answered by AI

Does this research encompass participants aged 30 and above?

"Participants must be adults between the ages of 18 and 70 to qualify for this medical trial."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Oregon
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~31 spots leftby Oct 2024