Clinical trial NCT01030107: Effects of Sleep Duration on Eating and Activity Behaviors
Official title: Sleep Duration and Pediatric Overweight: the Role of Eating Behaviors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Obesity
Keywords: sleep
obesity
children
eating behaviors
activity
leptin
ghrelin
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2009-12-11
Enrollment: 37
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 8-11 years old recruited from Southeastern New England.

Brief summary: The purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. For 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to increase their sleep first and half to decrease their sleep first. During each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight. We believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.


Eligibility criteria: Inclusion Criteria:

* Age 8-11 years old
* BMI for age and gender \> 5th percentile (but no greater than 100% overweight)
* Sleep approximately 9-10 hours nightly
* Attend elementary school
* Like at least 1 food and 1 activity used in the reinforcement paradigm
* Able to understand and complete the reinforcement paradigm

Exclusion Criteria:

* Existence of a diagnosable sleep disorder
* Medical or psychiatric condition that could influence sleep or weight
* Onset of menarche
* Inability to complete study materials, including diagnosed disabilities
* Dietary restrictions/allergies to foods used in the study that preclude them from study participation

Primary outcomes:
measure: absolute reinforcing value of food as compared to sedentary activities
timeFrame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
Secondary outcomes:
measure: plasma levels of leptin and ghrelin
timeFrame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
measure: caloric intake
timeFrame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
measure: levels of physical activity
timeFrame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
measure: subjective ratings of hunger and appetite
timeFrame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital/Alpert Medical School of Brown University
name: Chantelle N Hart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hart CN, Spaeth AM, Egleston BL, Carskadon MA, Raynor HA, Jelalian E, Owens JA, Considine RV, Wing RR. Effect of changes in children's bedtime and sleep period on targeted eating behaviors and timing of caloric intake. Eat Behav. 2022 Apr;45:101629. doi: 10.1016/j.eatbeh.2022.101629. Epub 2022 Mar 26.
citation: Hart CN, Carskadon MA, Considine RV, Fava JL, Lawton J, Raynor HA, Jelalian E, Owens J, Wing R. Changes in children's sleep duration on food intake, weight, and leptin. Pediatrics. 2013 Dec;132(6):e1473-80. doi: 10.1542/peds.2013-1274. Epub 2013 Nov 4.