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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jianghong Liu，University of Pennsylvania

Tracking Information

First Submitted Date ^ICMJE

July 30, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

May 15, 2018

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sleep[ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pilot Study on the Effects of Omega-3 Fatty Acid Supplements on Sleep and Behavior of Mother-child Pairs

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Dietary Supplement: Omega-3 fatty acids
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).
Dietary Supplement: Placebo
200 mL placebo fruit juice with no effect on the hypothesized outcome.

Study Arms

Experimental: 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 Comparator: 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).

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2019

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - child between ages 5-9 with mother available to participate in intervention study Exclusion Criteria: - intellectual disability - significant psychiatric and physical illness - extensive use of nutritional supplements within the past three months - seafood allergy - diabetes

Sex/Gender

Sexes Eligible for Study:

All

Ages

5 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jianghong Liu，University of Pennsylvania

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Jianghong Liu, PhD University of Pennsylvania

PRS Account

University of Pennsylvania

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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