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
BackgroundThe 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. ObjectiveThis p...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-05-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/5/e37002 |
| _version_ | 1797735087715909632 |
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| author | Jennette P Moreno Hafza Dadabhoy Salma Musaad Tom Baranowski Debbe Thompson Candice A Alfano Stephanie J Crowley |
| author_facet | Jennette P Moreno Hafza Dadabhoy Salma Musaad Tom Baranowski Debbe Thompson Candice A Alfano Stephanie J Crowley |
| author_sort | Jennette P Moreno |
| collection | DOAJ |
| description |
BackgroundThe 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.
ObjectiveThis 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.
MethodsThis 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.
ResultsThis 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.
ConclusionsThis 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 RegistrationClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740.
International Registered Report Identifier (IRRID)DERR1-10.2196/37002 |
| first_indexed | 2024-03-12T12:53:58Z |
| format | Article |
| id | doaj.art-ddfe125015fc434cba3d242d26ce3abb |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:53:58Z |
| publishDate | 2022-05-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-ddfe125015fc434cba3d242d26ce3abb2023-08-28T21:46:53ZengJMIR PublicationsJMIR Research Protocols1929-07482022-05-01115e3700210.2196/37002Evaluation 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 StudyJennette P Morenohttps://orcid.org/0000-0002-9372-6104Hafza Dadabhoyhttps://orcid.org/0000-0003-4571-4675Salma Musaadhttps://orcid.org/0000-0003-1733-830XTom Baranowskihttps://orcid.org/0000-0002-0653-2222Debbe Thompsonhttps://orcid.org/0000-0002-5491-8816Candice A Alfanohttps://orcid.org/0000-0001-7437-5575Stephanie J Crowleyhttps://orcid.org/0000-0003-2057-9876 BackgroundThe 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. ObjectiveThis 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. MethodsThis 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. ResultsThis 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. ConclusionsThis 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 RegistrationClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740. International Registered Report Identifier (IRRID)DERR1-10.2196/37002https://www.researchprotocols.org/2022/5/e37002 |
| spellingShingle | Jennette P Moreno Hafza Dadabhoy Salma Musaad Tom Baranowski Debbe Thompson Candice A Alfano Stephanie J Crowley 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 |
| 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 |
| url | https://www.researchprotocols.org/2022/5/e37002 |
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