Guelph Family Health Study: Pilot Study
- Conditions
- Obesity
- Interventions
- Behavioral: Emails and 2 home visitsBehavioral: Emails and 4 Home VisitsBehavioral: Control
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
- Arm && Interventions
Group Intervention Description Email and 2 Home Visits Emails and 2 home visits Weekly emails and 2 home visits Email and 4 Home Visits Emails and 4 Home Visits Weekly emails and 4 home visits with a health educator Control Control Control- monthly mailed information on children's health
- Primary Outcome Measures
Name Time Method change in adiposity baseline, 6 month follow-up
- Secondary Outcome Measures
Name Time Method change in body mass index baseline, 6-month follow-up change in frequency of family meals baseline, 6-month follow-up 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 waist circumference 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
Trial Locations
- Locations (1)
Univeristy of Guelph
🇨🇦Guelph, Ontario, Canada