Behavior Problem, Disturbances in Initiating and Maintaining Sleep
Conditions
Keywords
Omega-3 fatty acids, Sleep, Behavior, Parenting
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).
Interventions
DIETARY_SUPPLEMENTOmega-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_SUPPLEMENTPlacebo
200 mL placebo fruit juice with no effect on the hypothesized outcome.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed