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Due to challenges regarding COVID-19, it was not possible to reach the study's target sample size.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short sleep | Experimental | No more than 8 hours of sleep for 4 consecutive nights. |
|
| Long sleep | Experimental | At least 10 hours of sleep for 4 consecutive nights |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short sleep | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Sleep Duration | Mothers' bedtimes and wakeup times will be assessed by self report. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanna M Martinez, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23729925 | Background | 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. | |
| 17056861 | Background | 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. |
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Recruitment started on June 17, 2018 and ended March 9, 2020. Participants were recruited from local San Francisco nonprofit organizations, after school programs, local community events, a federally-qualified community health center and UCSF health clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Sleep | This condition required sleeping for less than 8 hours per night for one week. |
| FG001 | Long Sleep | This condition required sleeping for more than 10 hours per night for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Sleep | No more than 8 hours of sleep for 4 consecutive nights. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Sleep Duration by Sleep Condition. | Sleep duration will be measured with accelerometers. | Posted | Mean | Standard Deviation | hours | One week |
|
No adverse events occurred during the duration of the study (1 year, 9 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short Sleep | No more than 8 hours of sleep for 4 consecutive nights. 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanna Martinez | University of California, San Francisco | 415-476-2300 | suzanna.martinez@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2019 | Apr 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2020 | Apr 25, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2019 | Apr 23, 2025 | ICF_002.pdf |
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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).
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|
| Long sleep | 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. |
|
|
| One week |
| Baseline measurement (one time point) |
| 22911935 | Background | 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. |
| 19333745 | Background | 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. |
| 26547544 | Background | 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. |
| BG001 | Long Sleep | At least 10 hours of sleep for 4 consecutive nights 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | San Francisco Bay Area participants based on eligibility requirement | Number | participants |
|
| BMI z-score | BMI z-score of 0 represents the population mean. Clinical cut-offs for overweight risk: BMI z-score greater than +1.0; overweight: BMI z-score greater than +2.0; obese: BMI z-score greater than +3.0. | Mean | Standard Deviation | BMI z-score: 0 is the population average |
|
| Sleep duration | Sleep duration was assessed by maternal report of child's usual time to bed and time to wake up. | Mean | Standard Deviation | hours per night |
|
|
|
| Primary | 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. | minutes of daily moderate to vigorous physical activity | Posted | Mean | Standard Deviation | minutes | One week |
|
|
|
| Primary | 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. | average carbohydrate intake | Posted | Mean | Standard Deviation | kcals | One week |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | grams | One week |
|
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| Secondary | Maternal Sleep Duration | Mothers' bedtimes and wakeup times will be assessed by self report. | Mothers' reported sleep. | Posted | Mean | Standard Deviation | hours | Baseline measurement (one time point) |
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| Secondary | 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. | Number of participants who watched TV in bed as a nighttime routine at least once per week. | Posted | Count of Participants | Participants | Baseline measurement (one time point) |
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| 0 |
| 17 |
| 0 |
| 17 |
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| 17 |
| EG001 | Long Sleep | At least 10 hours of sleep for 4 consecutive nights 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. 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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