Summertime: Kids in Motion

Not Applicable

Terminated

• Conditions: Sleep
• Interventions: Behavioral: Short sleep; Behavioral: Long sleep

• Registration Number: NCT03947918
• Lead Sponsor: University of California, San Francisco

Brief Summary

This is a 3-week randomized crossover study to determine the effect of the prior night's sleep duration on energy-balance related behaviors of diet and physical activity the following day. In Week 1, child participants will sleep their usual amount. In week 2, participants will be randomized to either a sleep restricted or a healthy sleep condition for 4 nights. In week 3, participants will cross over to the opposite sleep condition for 4 nights.

Detailed Description

Individuals of Mexican descent comprise the largest proportion of the Latino population in the United States and they suffer high rates of obesity. Short sleep is a risk factor for obesity. An improved understanding of the underlying behavioral mechanisms by which short sleep duration may impact obesity among Mexican American children is critical to prevent and/or reduce obesity and chronic disease in this population. This research will focus on behavioral mechanisms (i.e., diet and physical activity) that link sleep duration to obesity. Mexican American 8-10-year-olds will participate in a 3-week crossover study to examine: 1) contextual factors (i.e., bedtime routines, sleep hygiene, familism) that may impact sleep; and 2) the impact of prior night's sleep duration on diet and physical activity the subsequent day. This research design will make it possible to examine whether sufficient sleep is protective of energy balance (e.g., healthful dietary intake/patterns and physical activity) as well as contextual factors related sleep.

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-13
• Study Start: 2019-06-17
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Mexican American child-mother pairs which will include: child 8-10 years old; mother/female guardian; English/Spanish speakers; mobile phone user.

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Exclusion Criteria

• Children with major illnesses and/or with sleep apnea for which children
• In families where 2 children are eligible for participation, a child will be selected at random to participate in the study.
• The investigators will exclude fathers from this study for reasons due to statistical power

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Short sleep	Long sleep	No more than 8 hours of sleep for 4 consecutive nights.
Short sleep	Short sleep	No more than 8 hours of sleep for 4 consecutive nights.
Long sleep	Short sleep	At least 10 hours of sleep for 4 consecutive nights
Long sleep	Long sleep	At least 10 hours of sleep for 4 consecutive nights

Primary Outcome Measures

Name	Time	Method
The effect of short sleep the prior night on physical activity (outcome) the subsequent day.	One week	Sleep duration will be measured with accelerometers. Physical activity will be measured with accelerometers (same as for sleep). Accelerometer data will be used to calculate moderate- to vigorous-intensity physical activity (minutes).
The effect of long sleep the prior night on eating (outcome) the subsequent day.	One week	Sleep duration will be measured with accelerometers. Eating/dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Sleep duration will be measured with accelerometers. Dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Daily sugar intake (grams) will be calculated.
The effect of short sleep the prior night on eating (outcome) the subsequent day.	One week	Sleep duration will be measured with accelerometers. Eating/dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Caloric intake (kcals) will be calculated.
The effect of long sleep the prior night on physical activity the subsequent day.	One week	Sleep duration will be measured with accelerometers. Physical activity will be measured with accelerometers (same as for sleep). Accelerometer data will be used to calculate moderate- to vigorous-intensity physical activity (minutes).

Secondary Outcome Measures

Name	Time	Method
Family acculturation factors related to children's sleep schedules.	Baseline measurement (one time point)	Acculturation will be assessed using the bidimensional acculturation scale for Hispanics (range 1-5; Marin \& Gamba, 1996). Child sleep schedule (bedtime) will be measured by parent report.
Sleep hygiene related to children's sleep schedules.	Baseline measurement (one time point)	Sleep hygiene will be assessed by whether the child shares a bed, shares a room and a bed, shares a room (but not a bed), or does not any. Child sleep schedule (wake time) will be measured by parent report.
Family sleep schedules related to children's sleep duration.	Baseline measurement (one time point)	Parent and child bedtimes and wakeup times will be assessed by parent report. Sleep duration will be measured with accelerometers (minutes).

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States