SleepNCT03947918
Summertime: Kids in Motion
A study testing Short sleep and Long sleep in people with Sleep, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Short sleep and Long sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2018to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mexican American child-mother pairs which will include: child 8-10 years old; mother/female guardian; English/Spanish speakers; mobile phone user.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94118
About this study
Official title: Sleep Duration and Risk for Obesity in Mexican American Children
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Short sleep, Long sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short sleepBehavioural
Also called Restricted 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.
Long sleepBehavioural
Also called Healthy 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.
| Study group | Role | What they receive |
|---|---|---|
| Short sleep | Experimental | No more than 8 hours of sleep for 4 consecutive nights. Receives: Behavioral: Short sleep; Behavioral: Long sleep |
| Long sleep | Experimental | At least 10 hours of sleep for 4 consecutive nights Receives: Behavioral: Short sleep; Behavioral: Long sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Sleep Duration by Sleep Condition.
Sleep duration will be measured with accelerometers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One week
Secondary outcomes (2)
Maternal Sleep Duration
Mothers' bedtimes and wakeup times will be assessed by self report.
Measured: Baseline measurement (one time point)
Sleep Hygiene Related to Children's Sleep Schedules.
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.
Measured: Baseline measurement (one time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start17 Jun 2018
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Why it stopped: Due to challenges regarding COVID-19, it was not possible to reach the study's target sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanna M Martinez, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947918
- Sponsor's protocol ID
- 1K01HL129087-01A1
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2019
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23729925Taheri 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.
PubMed 17056861Rendall 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.
PubMed 22911935Singh 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.
PubMed 19333745Martinez 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.
PubMed 26547544
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Duration and Risk for Obesity in Mexican American Children
- ClinicalTrials.gov ID
- NCT03947918
- Acronym / sponsor ID
- 1K01HL129087-01A1
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to challenges regarding COVID-19, it was not possible to reach the study's target sample size.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 17 Jun 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Short sleep | Experimental | Behavioral: Short sleep, Behavioral: Long sleepNo more than 8 hours of sleep for 4 consecutive nights. |
| Long sleep | Experimental | Behavioral: Short sleep, Behavioral: Long sleepAt least 10 hours of sleep for 4 consecutive nights |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Mexican American child-mother pairs which will include: child 8-10 years old; mother/female guardian; English/Spanish speakers; mobile phone user.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short sleepAlso: Restricted sleepChild 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. | Behavioural | Long sleep, Short sleep |
| Long sleepAlso: Healthy sleepChild 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. | Behavioural | Long sleep, Short sleep |
Primary outcome
Differences in Sleep Duration by Sleep Condition.
Time frame: One week
Sleep duration will be measured with accelerometers.
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.
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.
2 secondary outcomes
Maternal Sleep Duration
Time frame: Baseline measurement (one time point)
Sleep Hygiene Related to Children's Sleep Schedules.
Time frame: Baseline measurement (one time point)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23729925Beebe 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.
- Background: PubMed 17056861Taheri 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.
- Background: PubMed 22911935Rendall 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.
- Background: PubMed 19333745Singh 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.
- Background: PubMed 26547544Martinez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanna M Martinez, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short sleep and Long sleep in people with Sleep, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Sleep Duration by Sleep Condition. (time frame: One week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03947918, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.