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i♥rhythm project for Obesity Prevention

N/A

Waitlist Available

Led By Jennette Moreno

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 months, 3 months, 12 months and 15 months

Awards & highlights

Study Summary

This trial will test if a new medical intervention is feasible, acceptable, and has preliminary efficacy. If successful, the intervention will move on to a fully powered randomized controlled trial.

Eligible Conditions

Obesity Prevention

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 months, 3 months, 12 months and 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 months, 3 months, 12 months and 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 months, 3 months, 12 months and 15 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

Feasibility Criteria: ability to recruit the needed sample size

Treatment Acceptability

Secondary outcome measures

Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.

Anthropometrics

Bedtime Routines

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants will receive an intervention and will participate in assessments

Group II: ControlActive Control1 Intervention

Participants will not receive an intervention, but will participate in assessments

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

i♥rhythm project

2021

N/A

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,160 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,558 Total Patients Enrolled

2 Trials studying Obesity Prevention

1,089 Patients Enrolled for Obesity Prevention

Hafza Dadabhoy, MSStudy DirectorBaylor College of Medicine

Frequently Asked Questions

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

What are the major goals that this clinical trial is hoping to achieve?

"This three-month trial's primary focus is to assess Treatment Acceptability. Secondary metrics include Stress (Parent) which is determined by the Perceived Stress Scale, Social Support (Parent) measured using a self-report Interpersonal Support Evaluation List, and Actigraphy for assessing sleep/wake patterns, physical activity levels and light exposure."

Answered by AI

Who meets the eligibility criteria to participate in this research?

"Aspiring participants must meet the criteria of being obese and aged between 5 and 60. This clinical trial is hoping to recruit roughly 80 patients."

Answered by AI

To what extent is participation in this experiment limited?

"Affirmative. Per the clinicaltrials.gov portal, this investigation is actively recruiting and was initially posted to the platform on March 15th 2021 with a subsequent update occurring July 18th 2022. The research requires 80 volunteers from one site specifically."

Answered by AI

Is the age limit for enrollment in this experiment greater than twenty years?

"This research trial is looking for participants that are between 5 and 60 years old."

Answered by AI

Is this medical research endeavor still accepting new participants?

"According to clinicaltrials.gov, this trial has been recruiting participants since its initial posting on March 15th 2021 and is still open for applications as of July 18th 2022."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

Evaluation of a Circadian Rhythm and Sleep-focused Mobile Health Intervention for the Prevention of Accelerated Summer Weight Gain Among Elementary School–age Children: Protocol for a Randomized Controlled Feasibility Study

Moreno, Jennette P, Hafza Dadabhoy, Salma Musaad, Tom Baranowski, Debbe Thompson, Candice A Alfano, and Stephanie J Crowley. 2022. “Evaluation of a Circadian Rhythm and Sleep-focused Mobile Health Intervention for the Prevention of Accelerated Summer Weight Gain Among Elementary School–age Children: Protocol for a Randomized Controlled Feasibility Study”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/37002.

SleepJournal

Estimating Circadian Phase in Elementary School Children: Leveraging Advances in Physiologically Informed Models of Circadian Entrainment and Wearable Devices

Moreno, Jennette P, Kevin M Hannay, Olivia Walch, Hafza Dadabhoy, Jessica Christian, Maurice Puyau, Abeer El-Mubasher, et al.. 2022. “Estimating Circadian Phase in Elementary School Children: Leveraging Advances in Physiologically Informed Models of Circadian Entrainment and Wearable Devices”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/zsac061.

clinicaltrials.govStudy

The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention

Jennette P. Moreno 2021. "The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04445740.