Trial Outcomes & Findings for Summertime: Kids in Motion (NCT NCT03947918)

NCT ID: NCT03947918

Last Updated: 2025-04-25

Results Overview

Sleep duration will be measured with accelerometers.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

One week

Results posted on

2025-04-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Short Sleep
This condition required sleeping for less than 8 hours per night for one week.
Long Sleep
This condition required sleeping for more than 10 hours per night for one week.
Overall Study
STARTED
17
17
Overall Study
COMPLETED
16
14
Overall Study
NOT COMPLETED
1
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Summertime: Kids in Motion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Short Sleep
n=16 Participants
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.
Long Sleep
n=14 Participants
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.
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
<=18 years
16 Participants
n=5 Participants
14 Participants
n=7 Participants
30 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
9.69 years
STANDARD_DEVIATION 1.09 • n=5 Participants
9.74 years
STANDARD_DEVIATION .70 • n=7 Participants
9.71 years
STANDARD_DEVIATION .92 • n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
8 Participants
n=7 Participants
17 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
n=5 Participants
14 Participants
n=7 Participants
30 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
16 participants
n=5 Participants
14 participants
n=7 Participants
30 participants
n=5 Participants
BMI z-score
1.57 BMI z-score: 0 is the population average
STANDARD_DEVIATION 1.28 • n=5 Participants
2.17 BMI z-score: 0 is the population average
STANDARD_DEVIATION 1.21 • n=7 Participants
1.83 BMI z-score: 0 is the population average
STANDARD_DEVIATION 1.26 • n=5 Participants
Sleep duration
9.69 hours per night
STANDARD_DEVIATION .73 • n=5 Participants
10.32 hours per night
STANDARD_DEVIATION 1.68 • n=7 Participants
9.99 hours per night
STANDARD_DEVIATION 1.28 • n=5 Participants

PRIMARY outcome

Timeframe: One week

Sleep duration will be measured with accelerometers.

Outcome measures

Outcome measures
Measure
Short Sleep
n=16 Participants
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.
Long Sleep
n=14 Participants
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.
Differences in Sleep Duration by Sleep Condition.
8.4 hours
Standard Deviation .8
8.9 hours
Standard Deviation .6

PRIMARY outcome

Timeframe: One week

Population: minutes of daily moderate to vigorous physical activity

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.

Outcome measures

Outcome measures
Measure
Short Sleep
n=16 Participants
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.
Long Sleep
n=14 Participants
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.
Differences in Physical Activity (Outcome) by Short and Long Sleep Condition.
27 minutes
Standard Deviation 20
30 minutes
Standard Deviation 17

PRIMARY outcome

Timeframe: One week

Population: average carbohydrate intake

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.

Outcome measures

Outcome measures
Measure
Short Sleep
n=16 Participants
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.
Long Sleep
n=14 Participants
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.
Differences in Carbohydrate Intake by Long and Short Sleep Condition.
1312 kcals
Standard Deviation 484
1526 kcals
Standard Deviation 871

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Short Sleep
n=16 Participants
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.
Long Sleep
n=14 Participants
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.
Differences in Added Sugar Intake by Long and Short Sleep Condition.
62 grams
Standard Deviation 38
65 grams
Standard Deviation 55

SECONDARY outcome

Timeframe: Baseline measurement (one time point)

Population: Mothers' reported sleep.

Mothers' bedtimes and wakeup times will be assessed by self report.

Outcome measures

Outcome measures
Measure
Short Sleep
n=16 Participants
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.
Long Sleep
n=14 Participants
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.
Maternal Sleep Duration
5.91 hours
Standard Deviation 2.15
7.56 hours
Standard Deviation 3.53

SECONDARY outcome

Timeframe: Baseline measurement (one time point)

Population: Number of participants who watched TV in bed as a nighttime routine at least once per week.

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.

Outcome measures

Outcome measures
Measure
Short Sleep
n=16 Participants
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.
Long Sleep
n=14 Participants
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.
Sleep Hygiene Related to Children's Sleep Schedules.
7 Participants
9 Participants

Adverse Events

Short Sleep

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Long Sleep

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanna Martinez

University of California, San Francisco

Phone: 415-476-2300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place