Summertime: Kids in Motion

NCT ID: NCT03947918

Last Updated: 2025-04-25

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-17

Study Completion Date

2020-03-09

Brief Summary

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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

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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.

Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Short sleep

No more than 8 hours of sleep for 4 consecutive nights.

Group Type EXPERIMENTAL

Short sleep

Intervention Type BEHAVIORAL

Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.

Long sleep

Intervention Type BEHAVIORAL

Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.

Long sleep

At least 10 hours of sleep for 4 consecutive nights

Group Type EXPERIMENTAL

Short sleep

Intervention Type BEHAVIORAL

Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.

Long sleep

Intervention Type BEHAVIORAL

Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.

Interventions

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Short sleep

Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.

Intervention Type BEHAVIORAL

Long sleep

Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.

Intervention Type BEHAVIORAL

Other Intervention Names

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Restricted sleep Healthy sleep

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suzanna M Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23729925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17056861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22911935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19333745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26547544 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K01HL129087-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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