Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Moreno JP

PROVIDER: S-EPMC9152728 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 JP Dadabhoy Hafza H Musaad Salma S Baranowski Tom T Thompson Debbe D Alfano Candice A CA Crowley Stephanie J SJ

JMIR research protocols 20220516 5

<h4>Background</h4>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.<h4>Objective</h4>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 ...[more]

PMID: 35576573

Similar Datasets

Project description:Objectives and backgroundSocial demands of the school-year and summer environment may affect children's sleep patterns and circadian rhythms during these periods. The current study examined differences in children's sleep and circadian-related behaviors during the school-year and summer and explored the association between sleep and circadian parameters and change in body mass index (BMI) during these time periods.MethodsThis was a prospective observational study with 119 children ages 5 to 8 years with three sequential BMI assessments: early school-year (fall), late school-year (spring), and beginning of the following school-year in Houston, Texas, USA. Sleep midpoint, sleep duration, variability of sleep midpoint, physical activity, and light exposure were estimated using wrist-worn accelerometry during the school-year (fall) and summer. To examine the effect of sleep parameters, physical activity level, and light exposure on change in BMI, growth curve modeling was conducted controlling for age, race, sex, and chronotype.ResultsChildren's sleep midpoint shifted later by an average of 1.5 h during summer compared to the school-year. After controlling for covariates, later sleep midpoints predicted larger increases in BMI during summer, (γ = .0004, p = .03), but not during the school-year. Sleep duration, sleep midpoint variability, physical activity levels, and sedentary behavior were not associated with change in BMI during the school-year or summer. Females tended to increase their BMI at a faster rate during summer compared to males, γ = .06, p = .049. Greater amounts of outdoor light exposure (γ = -.01, p = .02) predicted smaller increases in school-year BMI.ConclusionsObesity prevention interventions may need to target different behaviors depending on whether children are in or out of school. Promotion of outdoor time during the school-year and earlier sleep times during the summer may be effective obesity prevention strategies during these respective times.

Project description:Background: Several studies have found that children in the United States gain weight at a faster rate in the summer than in the school year, but little is known about the prevalence of this problem, its effect on high-risk subgroups, or its determinants. This study compares school year and summer weight change in a low-income, ethnically diverse sample of school-age children in Massachusetts and explores differences by race/ethnicity, weight status, and exposure to school year physical activity (PA) programming. Diet and PA are examined as potential mediators of summer weight gain. Methods: Children participating in a school-based PA program evaluation (in which weight change was not a primary outcome) had their height and weight measured three times between October 2015 and September 2016 to capture a school year and summer interval. Diet and PA patterns were assessed mid-school year and mid-summer in a subsample of children. Mixed linear models were used to estimate the effect of season (school year vs. summer) on change in BMI and to examine the influence of race/ethnicity, weight status, and program (walk/run, classroom activity breaks, or control) on any observed effects. Structural equation models were used to explore diet and PA as mediators of seasonal weight change in a subsample of participants. Results: Of 769 participants, 53% were non-Caucasian, 40% were overweight or obese, and 58% were eligible for free or reduced-price school meals. BMI increased in both the school year and summer but increased more rapidly in the summer (0.046 kg/m2 more per month, p = 0.007). Of the three tested interactions, statistical significance was only observed between season and program (χ2 = 14.90, p < 0.001); on average, children exposed to a school year walk/run program did not gain weight more rapidly during the summer, whereas children in the control group and a classroom activity breaks program did. Poorer diet and PA patterns were observed in the summer, but neither diet nor PA was statistically significant mediators of BMI change. Conclusions: Children in this high-risk sample gained weight at a faster rate during the summer than during the school year, with no discernable demographic differences. However, this phenomenon was not observed in the subgroup exposed to a school year walk/run program. More research is needed to clarify the determinants of summer weight gain and understand how school year programming and its effects can be transferred to the summer months.

Project description:BACKGROUND:There is growing evidence that school children in the United States gain weight more rapidly during the summer than the school year, but few studies have explored the causes of this phenomenon. The goal of this study was to qualitatively explore potential determinants of accelerated summer weight gain by interviewing parents of school-age children. METHODS:Key informant interviews were conducted with parents of third and fourth grade students enrolled in a school-based physical activity intervention in three peri-urban communities in Eastern Massachusetts. A structured interview guide was developed to assess school year and summertime differences in child diet, physical activity, daily routine, and family rules. Interviews were recorded and transcribed verbatim. Transcripts were coded and major themes were identified using thematic analysis. RESULTS:Summer activities varied substantially by family. Many parents characterized summer as a time with less structure and more relaxed rules, particularly around bedtime and screen use. Parents perceived their child to be more physically active in the summer and reported few barriers to summertime physical activity. Parents reported increases in both positive (increased consumption of fruits and vegetables) and negative (increased consumption of "sweets" and "junk foods") dietary behaviors. They highlighted several stressors unique to summer, such as the high cost of camps and the need to coordinate childcare and manage children's time. CONCLUSIONS:Parents perceived their children to be more physically active in the summer and consume more fruits and vegetables than during the school year. However, they also perceived children to consume more energy-dense, nutrient poor foods, engage in more screen time, and have later bedtimes during the summer. These behaviors are important targets for summertime obesity prevention interventions. Large-scale quantitative studies are needed to determine whether these parent perceptions reflect meaningful risk factors for accelerated summer weight gain.

Project description:BackgroundThis study assessed the initial feasibility and preliminary efficacy of providing children a free summer day camp and a parent intervention to improve self-regulation and mitigate accelerated summer BMI gain.MethodsThis pilot 2x2 factorial randomized control trial used a mixed-methods design to evaluate providing children a free summer day camp (SCV), a parent intervention (PI), and the combination of these two strategies (SCV+PI) to mitigate accelerated summer body mass index (BMI) gain. Progression criteria for feasibility and efficacy were assessed to determine if a full-scale trial was warranted. Feasibility criteria included recruitment capability (≥80 participants recruited) retention (≥70% participants retained), compliance (≥80% of participants attending the summer program with children attending ≥60% of program days, and ≥80% of participants completing goal setting calls with ≥60% of weeks syncing their child's Fitbit), and treatment fidelity (≥80% of summer program days delivered for ≥9 h/day, and ≥80% of participant texts delivered). Efficacy criteria were assessed via achieving a clinically meaningful impact on zBMI (i.e., ≥0.15). Changes in BMI were estimated using intent-to-treat and post hoc dose-response analyses via multilevel mixed-effects regressions.ResultsFor recruitment, capability and retention progression criteria were met with a total of 89 families participating and 24 participants randomized to the PI group, 21 randomized to the SCV group, 23 randomized to the SCV+PI group, and 21 randomized to the control. However, fidelity and compliance progression criteria were not achieved due to COVID-19 and lack of transportation. Progression criteria for efficacy was also not achieved as intent-to-treat analyses did not show changes in BMI gain that were clinically meaningful. Post hoc dose-response analyses showed that for each day (0 to 29) of summer programming children attended they gained -0.009 (95CI= -0.018, -0.001) less in BMI z score.ConclusionsEngagement in both the SCV and PI was not ideal due to COVID-19 and lack of transportation. Providing children with structured summer programming to mitigate accelerated summer BMI gain may be an effective strategy. However, because feasibility and efficacy progression criteria were not met, a larger trial is not warranted until further pilot work is completed to ensure children attend the programming.Trial registrationThe trial reported herein was prospectively registered at ClinicalTrials.gov. Trial #: NCT04608188.

Project description:Background: While children have been shown to have increased BMI during the summer compared to the school year, it is not known if this may be due to seasonal variations in height or weight separately. Methods: Trained nurses measured heights (cm) and weights (kg) in a cohort of Kindergarteners (n = 7648) twice per year from the beginning of kindergarten through 5th grade. Variation in height and weight by season (school year vs. summer) was examined using separate mixed-effects models. Season, sex, and BMI trajectory group were tested as fixed effects. Random effects included repeated measurements of time, students nested within a school, intercept, and slope for growth over time. Similar models using BMIz as the outcome examined the interaction of height or weight with season. Results: The rate of height gain was greater during the school year (∼Sept to April) compared to summer (∼April to Sept) (β = -0.05, SE = 0.013, p < 0.0001). The rate of weight gain did not differ seasonally. Height gain was more strongly associated with increased BMIz during summer compared to the school year (β =.02, SE = 0.005, p <0 .0001), mainly among children who remained healthy weight throughout elementary school (β = 0.014, SE = 0.003, p < 0.0001) and those who transitioned to a healthier weight status (β = 0.026, SE = 0.008, p = 0.004). We found a similar seasonal effect for the association between weight with BMIz among children who maintained a healthy weight status (β = 0.014, SE = 0.014, p < 0.0001). Conclusion: This study indicates seasonality in children's height gain, gaining height at a faster rate during the school year compared to the summer, while weight gain remained relatively more consistent throughout the year. Seasonality in height and weight gain had the greatest impact on BMIz among children with a healthy weight status. Future research with more frequent measurements is needed to better understand the seasonal regulation of children's growth and weight gain.

Dataset Information

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

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets