Guelph Family Health Study: Pilot Study

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02223234
• Lead Sponsor: University of Guelph

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-22
• Study Start: 2014-09
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in adiposity	baseline, 6 month follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Univeristy of Guelph; 🇨🇦 Guelph, Ontario, Canada