Clinical trial NCT03947918: Summertime: Kids in Motion
Official title: Sleep Duration and Risk for Obesity in Mexican American Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three-week study includes:

Week 1 - all children get usual sleep Tuesday-Friday.

Week 2 - children are randomized to getting no more than 8 hours or at least 10 hours of sleep (Tuesday-Friday).

Week 3 - children crossover to the opposite sleep condition (Tuesday-Friday).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in Sleep Duration by Sleep Condition.
timeFrame: One week
measure: Differences in Physical Activity (Outcome) by Short and Long Sleep Condition.
timeFrame: One week
measure: Differences in Carbohydrate Intake by Long and Short Sleep Condition.
timeFrame: One week
measure: Differences in Added Sugar Intake by Long and Short Sleep Condition.
timeFrame: One week
Secondary outcomes:
measure: Maternal Sleep Duration
timeFrame: Baseline measurement (one time point)
measure: Sleep Hygiene Related to Children's Sleep Schedules.
timeFrame: Baseline measurement (one time point)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Suzanna M Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beebe DW, Simon S, Summer S, Hemmer S, Strotman D, Dolan LM. Dietary intake following experimentally restricted sleep in adolescents. Sleep. 2013 Jun 1;36(6):827-34. doi: 10.5665/sleep.2704.
citation: Taheri S. The link between short sleep duration and obesity: we should recommend more sleep to prevent obesity. Arch Dis Child. 2006 Nov;91(11):881-4. doi: 10.1136/adc.2005.093013.
citation: Rendall MS, Weden MM, Fernandes M, Vaynman I. Hispanic and black US children's paths to high adolescent obesity prevalence. Pediatr Obes. 2012 Dec;7(6):423-35. doi: 10.1111/j.2047-6310.2012.00080.x. Epub 2012 Aug 21.
citation: Singh GK, Kogan MD, Yu SM. Disparities in obesity and overweight prevalence among US immigrant children and adolescents by generational status. J Community Health. 2009 Aug;34(4):271-81. doi: 10.1007/s10900-009-9148-6.
citation: Martinez SM, Thompson-Lastad A. Latino Parents' Insight on Optimal Sleep for Their Preschool-Age Child: Does Context Matter? Acad Pediatr. 2015 Nov-Dec;15(6):636-43. doi: 10.1016/j.acap.2015.07.003. Epub 2015 Sep 26.