Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk
Status: | Recruiting |
---|---|
Conditions: | Insomnia Sleep Studies, Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 8 - 11 |
Updated: | 10/11/2018 |
Start Date: | July 1, 2017 |
End Date: | December 2019 |
Contact: | Ashley Greer, MPH |
Email: | ashley.greer@temple.edu |
Phone: | 215-707-8650 |
Enhancing children's sleep duration and/or timing may represent a novel approach for weight
regulation and prevention of T2DM. The proposed study will assess how experimental changes in
children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African
American children ages 8-11 years old who sleep approximately 9.5 hours or less each night
will be enrolled into a 4-arm randomized controlled pilot to compare three experimental
manipulations in children's sleep to a "typical sleep" (TYP) control. Experimental arms will
include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45
minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2-
and 4-week follow-up, participants be weighed and measured for height, have body fat assessed
(bod pod), and their blood drawn (following an overnight fast). The pilot will provide
important data on the potential role of sleep in combating disparities in cardiometabolic
risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose
regulation and 2) to determine the effect of changes in sleep on additional measures of
glucose regulation and adiposity.
regulation and prevention of T2DM. The proposed study will assess how experimental changes in
children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African
American children ages 8-11 years old who sleep approximately 9.5 hours or less each night
will be enrolled into a 4-arm randomized controlled pilot to compare three experimental
manipulations in children's sleep to a "typical sleep" (TYP) control. Experimental arms will
include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45
minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2-
and 4-week follow-up, participants be weighed and measured for height, have body fat assessed
(bod pod), and their blood drawn (following an overnight fast). The pilot will provide
important data on the potential role of sleep in combating disparities in cardiometabolic
risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose
regulation and 2) to determine the effect of changes in sleep on additional measures of
glucose regulation and adiposity.
Eligible families who provide consent/assent will be enrolled into a five week study. All
families will complete assessments at baseline, two weeks and four weeks. Each assessment
lasts one week and children will be asked to wear an actigraph on their wrist (to measure
sleep) and an accelerometer on their hip (to measure physical activity). At the end of the
week families will be scheduled for a visit at the research center first thing in the morning
approximately one hour after waking and following an overnight fast. During this visit,
actigraphs and accelerometers will be downloaded and data will be reviewed with families.
Children will be weighed and measured for height and have their body composition assessed. To
measure glucose regulation, children will first have 5 ml of blood drawn in a fasted state.
They will then ingest a glucose solution (1.75 g/kg; maximum of 75 g) over 2 minutes, and
blood will be drawn (1.5 ml) 120 min after the child consumes the solution. At week 4, 5 ml
blood will be drawn fasting; OGTT will not be administered (see note below). Research staff
will also complete one-day dietary recalls with participants at each center-based assessment
to obtain information on all foods consumed over the previous 24-hour period. In addition, at
the baseline assessment only, parents will complete questionnaires on basic demographic
information and child sleep. It is anticipated that the total time for each assessment will
take approximately 2.5-3 hours (1 hour at 4 weeks). Following eligibility confirmation at the
baseline assessment, families will be randomized to one of four protocols: 1) Enhance TIB by
90 min/night; 2) Enhance TIB by 45 min/night; 3) Regularize Sleep Schedule; or 4) Typical
Sleep Schedule.
Continuous glucose monitoring In a voluntary subset of randomly selected children
(approximately n = 4/group) 72-hour continuous glucose monitoring (CGM) will be performed. If
the child and family agree to participate in CGM, they will come to the Center for an
additional visit during which a disposable subcutaneous glucose-sensing device connected to a
battery-operated recorder will be inserted subcutaneously (a thin tube under the surface of
the skin). This sensor measures glucose every ten seconds and records an average value every
five minutes.
families will complete assessments at baseline, two weeks and four weeks. Each assessment
lasts one week and children will be asked to wear an actigraph on their wrist (to measure
sleep) and an accelerometer on their hip (to measure physical activity). At the end of the
week families will be scheduled for a visit at the research center first thing in the morning
approximately one hour after waking and following an overnight fast. During this visit,
actigraphs and accelerometers will be downloaded and data will be reviewed with families.
Children will be weighed and measured for height and have their body composition assessed. To
measure glucose regulation, children will first have 5 ml of blood drawn in a fasted state.
They will then ingest a glucose solution (1.75 g/kg; maximum of 75 g) over 2 minutes, and
blood will be drawn (1.5 ml) 120 min after the child consumes the solution. At week 4, 5 ml
blood will be drawn fasting; OGTT will not be administered (see note below). Research staff
will also complete one-day dietary recalls with participants at each center-based assessment
to obtain information on all foods consumed over the previous 24-hour period. In addition, at
the baseline assessment only, parents will complete questionnaires on basic demographic
information and child sleep. It is anticipated that the total time for each assessment will
take approximately 2.5-3 hours (1 hour at 4 weeks). Following eligibility confirmation at the
baseline assessment, families will be randomized to one of four protocols: 1) Enhance TIB by
90 min/night; 2) Enhance TIB by 45 min/night; 3) Regularize Sleep Schedule; or 4) Typical
Sleep Schedule.
Continuous glucose monitoring In a voluntary subset of randomly selected children
(approximately n = 4/group) 72-hour continuous glucose monitoring (CGM) will be performed. If
the child and family agree to participate in CGM, they will come to the Center for an
additional visit during which a disposable subcutaneous glucose-sensing device connected to a
battery-operated recorder will be inserted subcutaneously (a thin tube under the surface of
the skin). This sensor measures glucose every ten seconds and records an average value every
five minutes.
Inclusion Criteria:
1. Parent-reported child race African American/Black.
2. Parent-reported child age of 8-11 years
3. Less than or equal to approximately 9.5 hours time in bed (TIB; based on actigraphy
and sleep diaries)
4. Variability in Sleep Patterns (based on actigraphy and sleep diaries)
5. BMI for age and gender > 85th percentile (but no greater than 100% overweight)
6. Self-reported parent age of 18 years, primary caretaker, and at home throughout the
study (i.e., at bedtimes and wake times)
7. Reported willingness to complete all study tasks, including blood draws
Exclusion Criteria:
1. Diagnosable Sleep Disorder
2. Parent-reported diagnosis of medical or psychiatric condition that may impact
sleep/weight status
3. Actively trying to lose weight
4. Inability to Understand or Complete Protocol
5. Sibling of enrolled subjects
We found this trial at
1
site
3500 North Broad Street
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Phone: 215-707-8650
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