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Completed

NCT Number: NCT01508793

Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors

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.

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Key information

Conditions

Sleep Behavior Behavior, Animal Body Weight Feeding Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Obesity Research and Education, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optimize Sleep

Behavioral

Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention

Primary outcomes

  1. Change in Sleep Duration

    Time frame: Baseline, 2-weeks, and 2-months

    Measured with actigraphy

  2. Change in Dietary Intake

    Time frame: Baseline, 2-weeks, and 2-months

    Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)

Secondary outcomes

  1. Change in the Reinforcing Value of Food

    Time frame: Baseline, 2-weeks, and 2-months

    Measured using a computer paradigm, the Behavioral Choice Task

  2. Change in activity

    Time frame: Baseline, 2-week, and 2-month

    Physical and sedentary activities assessed using accelerometers and self-report

  3. Change in zBMI

    Time frame: Baseline, 2-week, and 2-month

    Based on measured height and weight

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • Temple University

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2012
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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