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Summertime: Kids in Motion

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ClinicalTrials.gov Identifier: NCT03947918
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Behavioral: Short sleep Behavioral: Long sleep Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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).

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sleep Duration and Risk for Obesity in Mexican American Children
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Short sleep
No more than 8 hours of sleep for 4 consecutive nights.
Behavioral: 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.
Other Name: Restricted sleep

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.
Other Name: Healthy sleep

Experimental: Long sleep
At least 10 hours of sleep for 4 consecutive nights
Behavioral: 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.
Other Name: Restricted sleep

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.
Other Name: Healthy sleep




Primary Outcome Measures :
  1. The effect of short sleep the prior night on eating (outcome) the subsequent day. [ 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. Caloric intake (kcals) will be calculated.

  2. The effect of short sleep the prior night on eating (outcome) the subsequent day. [ 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. Healthy eating index scores (range 1-10) will be calculated.

  3. The effect of short sleep the prior night on eating (outcome) the subsequent day. [ 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. Daily sugar intake (grams) will be calculated.

  4. The effect of short sleep the prior night on physical activity (outcome) the subsequent day. [ Time Frame: 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).

  5. The effect of long sleep the prior night on eating (outcome) the subsequent day. [ 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. Caloric intake (kcals) will be calculated.

  6. The effect of long sleep the prior night on eating (outcome) the subsequent day. [ 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. Healthy Eating Index scores (range 1-10) will be calculated.

  7. The effect of long sleep the prior night on eating (outcome) the subsequent day. [ 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.

  8. The effect of long sleep the prior night on physical activity the subsequent day. [ Time Frame: 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 :
  1. Family sleep schedules related to children's sleep duration. [ Time Frame: 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).

  2. Family acculturation factors related to children's sleep schedules. [ Time Frame: 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.

  3. Family acculturation factors related to children's sleep schedules. [ Time Frame: 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 (wake time) will be measured by parent report.

  4. Sleep hygiene related to children's sleep schedules. [ Time Frame: 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 (bedtime) will be measured by parent report.

  5. Sleep hygiene related to children's sleep schedules. [ Time Frame: 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.



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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947918


Contacts
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Contact: Suzanna M Martinez, PhD 4154762300 suzanna.martinez@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94118
Contact: Suzanna M Martinez, PhD    415-476-2300    suzanna.martinez@ucsf.edu   
Principal Investigator: Suzanna M Martinez, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Suzanna M Martinez, PhD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03947918    
Other Study ID Numbers: 1K01HL129087-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No