An interventional study of Omega-3 fatty acids and Placebo in Disturbances in Initiating and Maintaining Sleep and Behavior Problem, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 5 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
The aim of this feasibility study is to determine whether a nutritional intervention in children and their parents can improve their sleep quality and behavior. The study is a randomized, double-blind, placebo-controlled parallel trial of omega-3 supplementation to children and their mothers.
Previous studies show omega-3 fatty acid supplements improve adolescent's antisocial behavior. However it is less known whether the same effect could be achieved in younger children. Furthermore it is not known whether omega-3 fatty acids could also improve parental behavior and parenting style which could further reduce behavioral problems in children. Moreover, we recently found that children who consume fish more frequently have less sleep problems but it is not known whether omega-3 supplements could also potentially improve children's sleep. We aim to test several hypotheses in this random controlled trial of omega-3 fatty acids.
The study design will consist of a double-blind, randomized placebo-controlled trial of children and their caregivers in a community sample in the city of Philadelphia. It will utilize a random parallel design, in which child and mother pairs will be randomly assigned to either omega-3 supplementation (treatment condition) or a placebo (control condition). This results in 2 groups: (1) child and caregiver both receiving omega-3 and (2) both parent and child receiving the placebo. Treatment will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of supplementation) and 90 days (45 days after the end of treatment).
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Exclusion Criteria:
Both the mother and child will receive omega-3 supplements in the form of a 200 mL drink to be taken once daily. The intervention will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of treatment), and 3 months (1 and a half months post-treatment).
Dietary Supplement: Omega-3 fatty acids
The mother and child will both receive a placebo drink to take daily, with no known effect on the brain. The intervention will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of treatment), and 3 months (1 and a half months post-treatment).
Dietary Supplement: Placebo
200 ml drink. The drink contains 840 mg total of omega-3 (360 mg of DHA, 240 mg of EPA, 200 mg of alpha-linolenic acid, and 40 mg of DPA).
200 mL placebo fruit juice with no effect on the hypothesized outcome.
Sleep
For parent sleep patterns, we will use the Pittsburgh Sleep Quality Index to evaluate changes. For children's sleep, we will use the Child Sleep Habits questionnaire.
Time frame: 3 months
Child behavior
Will use the Child Behavior Checklist to evaluate changes in child behavior.
Time frame: 3 months
Parental behavior
Will use the Adult Self Report to evaluate changes in parent behavior.
Time frame: 3 months
Child and parental cognitive behavior
Will use online cognitive test to evaluate changes in cognition.
Time frame: 3 months
Parental style
Will use the Alabama Parenting questionnaire to evaluate changes in parenting style.
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania