Summertime: Kids in Motion

Sleep Clinical Trial

Official title:

Sleep Duration and Risk for Obesity in Mexican American Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03947918
• Other study ID #: 1K01HL129087-01A1
• Status: Terminated
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: March 9, 2020

Study information

• Verified date: October 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Sleep

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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. — 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

Outcome

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)