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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

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 feas...

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Autores principales: Moreno, Jennette P, Dadabhoy, Hafza, Musaad, Salma, Baranowski, Tom, Thompson, Debbe, Alfano, Candice A, Crowley, Stephanie J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152728/
https://www.ncbi.nlm.nih.gov/pubmed/35576573
http://dx.doi.org/10.2196/37002
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author Moreno, Jennette P
Dadabhoy, Hafza
Musaad, Salma
Baranowski, Tom
Thompson, Debbe
Alfano, Candice A
Crowley, Stephanie J
author_facet Moreno, Jennette P
Dadabhoy, Hafza
Musaad, Salma
Baranowski, Tom
Thompson, Debbe
Alfano, Candice A
Crowley, Stephanie J
author_sort Moreno, Jennette P
collection PubMed
description 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37002
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spelling pubmed-91527282022-06-01 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 Dadabhoy, Hafza Musaad, Salma Baranowski, Tom Thompson, Debbe Alfano, Candice A Crowley, Stephanie J JMIR Res Protoc Protocol 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37002 JMIR Publications 2022-05-16 /pmc/articles/PMC9152728/ /pubmed/35576573 http://dx.doi.org/10.2196/37002 Text en ©Jennette P Moreno, Hafza Dadabhoy, Salma Musaad, Tom Baranowski, Debbe Thompson, Candice A Alfano, Stephanie J Crowley. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.05.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Moreno, Jennette P
Dadabhoy, Hafza
Musaad, Salma
Baranowski, Tom
Thompson, Debbe
Alfano, Candice A
Crowley, Stephanie J
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152728/
https://www.ncbi.nlm.nih.gov/pubmed/35576573
http://dx.doi.org/10.2196/37002
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