Guelph Family Health Study: Pilot Study

January 3, 2017 updated by: Jess Haines, University of Guelph

The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.

To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.

We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:

  1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period.
  2. higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes)
  3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.

We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • Univeristy of Guelph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • families who have a child aged 18 months through 5 years
  • live the Guelph area
  • have a parent who can respond to questionnaires in English

Exclusion Criteria:

  • families who plan to move during the study period
  • children with severe health conditions (such as severe cerebral palsy) that would prohibit them from participating in study activities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Control- monthly mailed information on children's health
Behavioral: Control
Monthly emails on child health
Experimental: Email and 4 Home Visits
Weekly emails and 4 home visits with a health educator
Behavioral: Emails and 4 Home Visits
Weekly emails and 4 home visits with health educator
Experimental: Email and 2 Home Visits
Weekly emails and 2 home visits
Behavioral: Emails and 2 home visits
Weekly emails and 2 home visits with health educator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in adiposity
Time Frame: baseline, 6 month follow-up
baseline, 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
change in body mass index
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up
change in waist circumference
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up
change in frequency of family meals
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up
change in child's sleep duration
Time Frame: baseline, 6-months
baseline, 6-months
change in child's physical activity
Time Frame: baseline, 6-months
baseline, 6-months
change in child's fruit and vegetable intake
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up
change in child's sugar-sweetened beverage intake
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up
change in sedentary behaviour
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up
change in child's diastolic blood pressure
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up
change in child's biomarkers of diabetes and cardiovascular disease risk
Time Frame: baseline, 6-month follow-up
baseline, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14AP008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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