Key result
The i♥rhythm mobile health intervention is being evaluated in an ongoing randomized feasibility study of 40 parent-child dyads to prevent accelerated summer weight gain in children aged 5-8 years.
Why the study?
To evaluate the feasibility, acceptability, and preliminary efficacy of the i♥rhythm mobile health intervention to prevent accelerated summer weight gain in children, in preparation for a fully powered trial.
Does the i♥rhythm mobile health intervention demonstrate feasibility, acceptability, and preliminary efficacy for the prevention of accelerated summer weight gain in 5-8-year-old children?
RCT (n=40)
Single-blind
2-group
Does the i♥rhythm mobile health intervention demonstrate feasibility, acceptability, and preliminary efficacy for the prevention of accelerated summer weight gain in 5-8-year-old children?
Answers are grounded in this paper and cite their sources.
This protocol outlines a feasibility study for a mobile health intervention aimed at promoting healthy sleep and behavioral rhythms to prevent summer weight gain in children.
BACKGROUND The i♥rhythm project is a mobile health adaptation of interpersonal and social rhythm therapy designed to promote healthy sleep and behavioral rhythms among 5-8-year olds during summer for the prevention of accelerated summer weight gain. OBJECTIVE This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the i♥rhythm intervention. This will ensure that 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 examine the willingness of participants to participate in the intervention and determine whether modifications to the intervention, procedures, and measures are needed before conducting a fully powered study. We will assess our ability to (1) recruit, consent, and retain participants; (2) deliver the intervention; (3) implement the study and assessment procedures; (4) assess the reliability of the proposed measures; and (5) assess the acceptability of the intervention and assessment protocol. METHODS This study will employ a single-blinded 2-group randomized control design (treatment and no-treatment control) with randomization occurring after baseline (Time 0) and 3 additional evaluation periods (postintervention [Time 1], and 9 months [Time 2] and 12 months after intervention [Time 3]). A sample of 40 parent-child dyads will be recruited. RESULTS This study was approved by the institutional review board of Baylor College of Medicine (H-47369). Recruitment began in March 2021. As of March 2022, data collection and recruitment are ongoing. CONCLUSIONS This study will address the role of sleep and circadian rhythms in the prevention of accelerated summer weight gain and assess the intervention’s effects on the long-term prevention of child obesity. CLINICALTRIAL ClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/37002
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Moreno et al. (2022) conducted an RCT in Accelerated summer weight gain (n=40). i♥rhythm intervention vs. No-treatment control was evaluated on Feasibility, acceptability, and preliminary efficacy. The i♥rhythm mobile health intervention is being evaluated in an ongoing randomized feasibility study of 40 parent-child dyads to prevent accelerated summer weight gain in children aged 5-8 years.
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