Sleep Clinical Trial
Official title:
Sleep Duration and Risk for Obesity in Mexican American Children
Verified date | October 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 34 |
Est. completion date | March 9, 2020 |
Est. primary completion date | March 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of short sleep the prior night on eating (outcome) the subsequent day. | 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. | One week | |
Primary | The effect of short sleep the prior night on physical activity (outcome) the subsequent day. | 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). | One week | |
Primary | The effect of long sleep the prior night on eating (outcome) the subsequent day. | 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. | One week | |
Primary | The effect of long sleep the prior night on eating (outcome) the subsequent day. | 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 | |
Primary | The effect of long sleep the prior night on physical activity the subsequent day. | 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). | One week | |
Secondary | Family sleep schedules related to children's sleep duration. | Parent and child bedtimes and wakeup times will be assessed by parent report. Sleep duration will be measured with accelerometers (minutes). | Baseline measurement (one time point) | |
Secondary | Family acculturation factors related to children's sleep schedules. | 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. | Baseline measurement (one time point) | |
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. | Baseline measurement (one time point) | |
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 (wake time) will be measured by parent report. | Baseline measurement (one time point) |
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