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

  • STATUS
    Recruiting
  • End date
    Aug 30, 2023
  • participants needed
    80
  • sponsor
    Baylor College of Medicine
Updated on 25 July 2022
Accepts healthy volunteers

Summary

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.

Description

The current study employs a 2 group randomized control design (treatment and no-treatment control) with randomization occurring after baseline (time 0) and 3 additional evaluation periods (end of intervention (time 1), and 9 months (time 2) and 12 months post intervention (time 3)). Because the the i♥rhythm project is intended to prevent children from beginning a trajectory toward overweight/obesity in elementary school, the impact of the intervention on change in standardized BMI (BMIz) during the following summer (time 2 and 3) will be explored, identifying whether a maintenance intervention is needed. Following the intervention and final data assessment (time 1 and 3), qualitative interviews will explore the acceptability of the intervention, treatment barriers and facilitators, difficulties with study procedures, maintenance of improvements, and self-efficacy to maintain improvements. A third treatment condition controlling for the effect of attention was beyond the scope of the current feasibility study.

Details
Condition Obesity Prevention
Treatment i♥rhythm project
Clinical Study IdentifierNCT04445740
SponsorBaylor College of Medicine
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Child has not participated in an obesity prevention or obesity treatment program in the last 6 months
Per parent report, the child is not being treated with a medication or supplement known to affect sleep
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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