Guelph Family Health Study: Pilot Study

Study Overview
=================
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: a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period. 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) 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.

Official Title
-----------------
Guelph Family Health Study: Pilot Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Emails and 4 Home Visits
* Behavioral: Control
* Behavioral: Emails and 2 home visits


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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