Effects of Sleep Duration on Eating and Activity Behaviors

Obesity Clinical Trial

Official title:

Sleep Duration and Pediatric Overweight: the Role of Eating Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030107
• Other study ID #: 1-08-JF-17
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: October 4, 2012
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: April 2011
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Sleep

Intervention

Behavioral:
• Increase Sleep
Children are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week.
• Decrease Sleep
Children are asked to decrease their sleep by approximately 1 1/2 hours/night.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute reinforcing value of food as compared to sedentary activities		after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration	No
Secondary	plasma levels of leptin and ghrelin		after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration	No
Secondary	caloric intake		after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration	No
Secondary	levels of physical activity		after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration	No
Secondary	subjective ratings of hunger and appetite		after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration	No

External Links

•   Weight Control and Diabetes Research Center