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

Completed · Not applicable

Conditions studied: Obesity Prevention

In brief

This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the intervention. This will ensure that all aspects of the research protocol and procedures work as desired and are acceptable to families in preparation for the fully powered randomized controlled trial. The proposed study will assess our ability to: 1)recruit, consent, and retain participants, 2) deliver the intervention, 3) implement study and assessment procedures 4) assess the reliability of the proposed measures in this sample, 5) determine whether modifications to the intervention, procedures, and measures are needed prior to conducting a fully powered study, and 6) willingness of participants to participate in the intervention.

Key facts

Study ID

NCT04445740

Run by

Baylor College of Medicine

People needed

92

Starts

2021-03-15

Expected to finish

2023-08-18

Last updated by the study team

2023-10-25

Who can join

Age: 5 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The index child is 5-8 years old and currently enrolled in kindergarten, first, or second grade
• Parent reports being a daily user of social media
• Parent willing to engage in an mobile health intervention that includes social media
• Parent owns a smart phone
• At least 1 parent is comfortable participating in the intervention and responding to questionnaires in English
• Index child has a BMI >50th percentile
• families live in the greater Houston area and able to attend in-person data collection at the Children's Nutrition Research Center.

You may not qualify if…

• Per parent report, the child does not have a chronic medical condition affecting sleep, eating behaviors, weight status, or behavioral rhythms (e.g., obstructive sleep apnea, attention deficit hyperactivity disorder, autism). The inclusion and exclusion criteria will be assessed using a screening questionnaire and assessments which will be administered following the consenting procedures.
• Per parent report, the child is not being treated with a medication or supplement known to affect sleep.
• Child has not participated in an obesity prevention or obesity treatment program in the last 6 months
• Child had not been retaine 2 or more grades for academic reason or has intellectual difficulities that would influence their ability to complet questionnaires or participate in interviews.

Where it is running

• Children's Nutrition Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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