Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
This study is currently recruiting participants.
Verified January 2012 by The Miriam Hospital
Sponsor:
The Miriam Hospital
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01508793
First received: January 5, 2012
Last updated: January 9, 2012
Last verified: January 2012
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Purpose
The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.
| Condition | Intervention |
|---|---|
|
Sleep Obesity |
Behavioral: Optimize Sleep |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by The Miriam Hospital:
Primary Outcome Measures:
- Change in Sleep Duration [ Time Frame: Baseline, 2-weeks, and 2-months ] [ Designated as safety issue: No ]Measured with actigraphy
- Change in Dietary Intake [ Time Frame: Baseline, 2-weeks, and 2-months ] [ Designated as safety issue: No ]Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)
Secondary Outcome Measures:
- Change in the Reinforcing Value of Food [ Time Frame: Baseline, 2-weeks, and 2-months ] [ Designated as safety issue: No ]Measured using a computer paradigm, the Behavioral Choice Task
- Change in activity [ Time Frame: Baseline, 2-week, and 2-month ] [ Designated as safety issue: No ]Physical and sedentary activities assessed using accelerometers and self-report
- Change in zBMI [ Time Frame: Baseline, 2-week, and 2-month ] [ Designated as safety issue: No ]Based on measured height and weight
| Estimated Enrollment: | 104 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Control | |
| Experimental: Optimize Sleep |
Behavioral: Optimize Sleep
Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention
|
Eligibility| Ages Eligible for Study: | 8 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 8-11 years old
- BMI for age and gender > 10th percentile (but no greater than 100% overweight)
- Sleep 9.5 hours or less nightly
- Attend elementary school
- Like at least 1 food used in the reinforcement paradigm
- Able to understand and complete the reinforcement paradigm
Exclusion Criteria:
- Existence of a diagnosable parasomnia, sleep disordered breathing
- Medical or psychiatric condition that could influence sleep or weight
- Inability to complete study materials, including diagnosed disabilities
- Dietary restrictions/allergies to foods used in the study that preclude them from study participation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508793
Contacts
| Contact: Chantelle Hart, Ph.D. | 401-793-9727 | chart@lifespan.org |
| Contact: Nicola Hawley, Ph.D. | 401-793-8931 | nhawley@lifespan.org |
Locations
| United States, Rhode Island | |
| Weight Control and Diabetes Research Center | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
Sponsors and Collaborators
The Miriam Hospital
Investigators
| Principal Investigator: | Chantelle N Hart, Ph.D. | The Miriam Hospital/Alpert Medical School of Brown University |
More Information
Additional Information:
No publications provided
| Responsible Party: | The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT01508793 History of Changes |
| Other Study ID Numbers: | R01HL092910 |
| Study First Received: | January 5, 2012 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Miriam Hospital:
|
Sleep Obesity Children Eating behaviors Activity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013