Condition category
Mental and Behavioural Disorders
Date applied
09/05/2017
Date assigned
18/05/2017
Last edited
18/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Behavioural problems in children are very common. There is evidence that the development of behavioural disorders such as ADHD (a condition which makes children hyperactive and impulsive, with short attention span, meaning they are easily distracted) and autism (a disorder which causes problems with the way that a person communicates and relates to others) are related to increased heavy metal exposure. This can happen from eating processed food products with ingredients containing allowed levels of inorganic mercury, lead and arsenic. This study is looking at a web-based nutrition tutorial which aims to help educate parents about what is in food. The aim of this study is to find out whether properly educating parents on the topic of toxic substances in the food supply and the negative effects of exposure to these toxic substances on child health can help them to make healthy dietary changes in the family home that may reduce problem behaviors in their child.

Who can participate?
A parent or guardian of children with learning difficulties, aged between 34 months and eight years.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the web-based tutorial programme on light over a period of six weeks. This will help educate them about toxic substances in food and their effects on their child’s health. Those in the second group continue as normal for the duration of the study. At the start of the study and after six weeks, participants in both groups complete surveys about their children’s dietary habits.

What are the possible benefits and risks of participating?
Participants may benefit from improving the health of their child by following a healthier diet. There are no notable risks involved with participating.

Where is the study run from?
Food Ingredient and Health Research Institute (USA)

When is the study starting and how long is it expected to run for?
October 2015 to October 2016

Who is funding the study?
Food Ingredient and Health Research Institute (USA)

Who is the main contact?
Dr Renee Dufault

Trial website

Contact information

Type

Public

Primary contact

Dr Renee Dufault

ORCID ID

http://orcid.org/0000-0002-8299-3768

Contact details

Food Ingredient and Health Research Institute
PO Box 1055
Naalehu
96772
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03

Study information

Scientific title

Efficacy of online nutritional epigenetics tutorial on parent diet using a semi-randomized control group pretest-posttest study design

Acronym

Study hypothesis

Hypothesis:
If parents are properly educated on the topic of toxic substances in the food supply and the adverse effects of exposure to these toxic substances on child health, then they can make dietary changes.

Study aim:
The aim of this study is to provide web based nutrition education for parents of learning-disabled children to enable them to make healthy dietary changes in the family home that may reduce problem behaviors in their child.

Ethics approval

A.T. Still University Institutional Review Board, 01/06/2015

Study design

Semi-randomised control group pretest-posttest design as described by Leedy and Ormond (2010) was used as the experimental study design to evaluate a web-based tutorial for use by parents of teach disabled children with problem behaviors to facilitate healthy dietary changes within a 6-week period.

Primary study design

Interventional

Secondary study design

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Learning disabilities associated with poor diet

Intervention

A web-based tutorial will be constructed online. Twenty parents are recruited to participate in the six week tutorial via Facebook. Interested parents fill out a screening questionnaire to determine their eligibility. Ten eligible parents are randomly assigned to participate in the six-week tutorial and ten eligible parents are assigned to the control group. Over the recruitment period, as the parents are enrolled in the study, one is assigned to the test group and the next one to enroll is assigned to the control group.

Intervention group: Participants receive six weeks of instruction that focuses on the nutritional factors known to impact gene behaviour to impact health and child behaviour.

Control group: Participants do not receive any instruction at all. They simply take the diet survey questionnaire pre and post intervention.

Pre and post intervention, all participants complete the online diet survey questionnaire comprised of 30 dietary habit questions and 10 participant characteristic questions.

Intervention type

Phase

Drug names

Primary outcome measures

Intake of highly processed food and whole foods is measured using survey questionnaire (by coding and determining diet scores for "intake of highly processed food" and "intake of whole and/or organic food") at baseline and after the six week tutorial.

Secondary outcome measures

No secondary outcome measures.

Overall trial start date

03/10/2015

Overall trial end date

01/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. A parent or guardian of an un-medicated learning-disabled child between the ages of 34 months and 8 years with behavior problems
2. Parents have a home computer with daily access to the internet
3. Parents eat the western diet (aka SAD) at the beginning of the intervention along with their family members (e.g. no special diets)
4. Parents have a minimum educational level equivalent to a high school diploma or GED by self-report

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Parents with learning-disabled children on medication for the treatment of autism or ADHD
2. Parents with learning-disabled children on special diets (e.g. gluten or casein free, Feingold, etc.)
3. Parents with learning-disabled children under the age of 34 months or over the age of 8 years
4. Parents without access to the Internet

Recruitment start date

01/07/2015

Recruitment end date

15/08/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

Food Ingredient and Health Research Institute
Naalehu
96772
United States of America

Sponsor information

Organisation

Food Ingredient and Health Research Institute

Sponsor details

PO Box 1055
Naalehu
96772
United States of America

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Food Ingredient and Health Research Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at Survey Monkey.

Intention to publish date

01/10/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes