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Clinical Trials/NCT03947918
NCT03947918TerminatedNot Applicable

Sleep Duration and Risk for Obesity in Mexican American Children

University of California, San Francisco2 sites in 1 country34 target enrollmentStarted: June 17, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
34
Locations
2
Primary Endpoint
Differences in Sleep Duration by Sleep Condition.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
8 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

Differences in Sleep Duration by Sleep Condition.

Time Frame: One week

Sleep duration will be measured with accelerometers.

Differences in Added Sugar Intake by Long and Short Sleep Condition.

Time Frame: 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.

Differences in Physical Activity (Outcome) by Short and Long Sleep Condition.

Time Frame: One week

Physical activity will be measured with accelerometers. Accelerometer data will be used to calculate moderate- to vigorous-intensity physical activity (MVPA; minutes). Activity counts were summed for each 24-hour period categorized into moderate to vigorous levels of physical activity according to the previously established thresholds. Moderate physical activity was set at 0.04 \< AEE \< 0.10 kcal.kg-1.min-1 or 3.0 \< PAR \< 6.0, reflective of medium exertion in the standing position. Vigorous physical activity was set at AEE \> 0.10 kcal.kg-1.min-1 or PAR \> 6.0, reflective of activities at a high level of exertion in the standing position. Moderate-intensity and vigorous-intensity physical activity were combined and expressed as minutes spent in MVPA.

Differences in Carbohydrate Intake by Long and Short Sleep Condition.

Time Frame: 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.

Secondary Outcomes

  • Maternal Sleep Duration(Baseline measurement (one time point))
  • Sleep Hygiene Related to Children's Sleep Schedules.(Baseline measurement (one time point))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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