NCT03947918

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

February 19, 2019

Results QC Date

April 29, 2024

Last Update Submit

April 23, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Differences in Sleep Duration by Sleep Condition.

    Sleep duration will be measured with accelerometers.

    One week

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

    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.

    One week

  • Differences in Carbohydrate Intake by Long and Short Sleep Condition.

    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.

    One week

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

    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.

    One week

Secondary Outcomes (2)

  • Maternal Sleep Duration

    Baseline measurement (one time point)

  • Sleep Hygiene Related to Children's Sleep Schedules.

    Baseline measurement (one time point)

Study Arms (2)

Short sleep

EXPERIMENTAL

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

Behavioral: Short sleepBehavioral: Long sleep

Long sleep

EXPERIMENTAL

At least 10 hours of sleep for 4 consecutive nights

Behavioral: Short sleepBehavioral: Long sleep

Interventions

Short sleepBEHAVIORAL

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.

Also known as: Restricted sleep
Long sleepShort sleep
Long sleepBEHAVIORAL

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.

Also known as: Healthy sleep
Long sleepShort sleep

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (5)

  • 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.

    PMID: 23729925BACKGROUND
  • 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.

    PMID: 17056861BACKGROUND
  • 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.

    PMID: 22911935BACKGROUND
  • 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.

    PMID: 19333745BACKGROUND
  • 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.

    PMID: 26547544BACKGROUND

Results Point of Contact

Title
Suzanna Martinez
Organization
University of California, San Francisco

Study Officials

  • Suzanna M Martinez, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

May 13, 2019

Study Start

June 17, 2018

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

April 25, 2025

Results First Posted

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations