Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)

Not Applicable

Completed

• Conditions: Disturbances in Initiating and Maintaining Sleep; Behavior Problem
• Interventions: Dietary Supplement: Omega-3 fatty acids; Dietary Supplement: Placebo

• Registration Number: NCT03694314
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2018-05-15
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-05
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• child between ages 5-9 with mother available to participate in intervention study

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Exclusion Criteria

• intellectual disability
• significant psychiatric and physical illness
• extensive use of nutritional supplements within the past three months
• seafood allergy
• diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Omega-3 fatty acids	Omega-3 fatty acids	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).
Placebo	Placebo	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).

Primary Outcome Measures

Name	Time	Method
Sleep	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Child behavior	3 months	Will use the Child Behavior Checklist to evaluate changes in child behavior.
Parental behavior	3 months	Will use the Adult Self Report to evaluate changes in parent behavior.
Child and parental cognitive behavior	3 months	Will use online cognitive test to evaluate changes in cognition.
Parental style	3 months	Will use the Alabama Parenting questionnaire to evaluate changes in parenting style.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States