Sleep
Conditions
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.
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.
Interventions
BEHAVIORALShort 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.
BEHAVIORALLong 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Sleep Duration by Sleep Condition. | One week | Sleep duration will be measured with accelerometers. |
| Differences in Physical Activity (Outcome) by Short and Long Sleep Condition. | 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. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Sleep Duration | Baseline measurement (one time point) | Mothers' bedtimes and wakeup times will be assessed by self report. |
| Sleep Hygiene Related to Children's Sleep Schedules. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Short Sleep | Long Sleep | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 14 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.69 years STANDARD_DEVIATION 1.09 | 9.74 years STANDARD_DEVIATION 0.7 | 9.71 years STANDARD_DEVIATION 0.92 |
| BMI z-score | 1.57 BMI z-score: 0 is the population average STANDARD_DEVIATION 1.28 | 2.17 BMI z-score: 0 is the population average STANDARD_DEVIATION 1.21 | 1.83 BMI z-score: 0 is the population average STANDARD_DEVIATION 1.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 14 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
| Sleep duration | 9.69 hours per night STANDARD_DEVIATION 0.73 | 10.32 hours per night STANDARD_DEVIATION 1.68 | 9.99 hours per night STANDARD_DEVIATION 1.28 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Sleep | Differences in Added Sugar Intake by Long and Short Sleep Condition. | 62 grams | Standard Deviation 38 |
| Long Sleep | Differences in Added Sugar Intake by Long and Short Sleep Condition. | 65 grams | Standard Deviation 55 |
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.
Time frame: One week
Population: average carbohydrate intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Sleep | Differences in Carbohydrate Intake by Long and Short Sleep Condition. | 1312 kcals | Standard Deviation 484 |
| Long Sleep | Differences in Carbohydrate Intake by Long and Short Sleep Condition. | 1526 kcals | Standard Deviation 871 |
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.
Time frame: One week
Population: minutes of daily moderate to vigorous physical activity
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Sleep | Differences in Physical Activity (Outcome) by Short and Long Sleep Condition. | 27 minutes | Standard Deviation 20 |
| Long Sleep | Differences in Physical Activity (Outcome) by Short and Long Sleep Condition. | 30 minutes | Standard Deviation 17 |
Primary
Differences in Sleep Duration by Sleep Condition.
Sleep duration will be measured with accelerometers.
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Sleep | Differences in Sleep Duration by Sleep Condition. | 8.4 hours | Standard Deviation 0.8 |
| Long Sleep | Differences in Sleep Duration by Sleep Condition. | 8.9 hours | Standard Deviation 0.6 |
Secondary
Maternal Sleep Duration
Mothers' bedtimes and wakeup times will be assessed by self report.
Time frame: Baseline measurement (one time point)
Population: Mothers' reported sleep.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Sleep | Maternal Sleep Duration | 5.91 hours | Standard Deviation 2.15 |
| Long Sleep | Maternal Sleep Duration | 7.56 hours | Standard Deviation 3.53 |
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.
Time frame: Baseline measurement (one time point)
Population: Number of participants who watched TV in bed as a nighttime routine at least once per week.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short Sleep | Sleep Hygiene Related to Children's Sleep Schedules. | 7 Participants |
| Long Sleep | Sleep Hygiene Related to Children's Sleep Schedules. | 9 Participants |