Univeristy of Guelph
Guelph, Ontario, N1G 2W1, Canada
NCT Number: NCT02223234
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Guelph, Ontario, N1G 2W1, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly emails and 4 home visits with health educator
Monthly emails on child health
Weekly emails and 2 home visits with health educator
Time frame: baseline, 6 month follow-up
Time frame: baseline, 6-month follow-up
Time frame: baseline, 6-month follow-up
Time frame: baseline, 6-month follow-up
Time frame: baseline, 6-months
Time frame: baseline, 6-months
Time frame: baseline, 6-month follow-up
Time frame: baseline, 6-month follow-up
Time frame: baseline, 6-month follow-up
Time frame: baseline, 6-month follow-up
Time frame: baseline, 6-month follow-up
University of Guelph
Other
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