Guelph Family Health Study: Pilot Study
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|ClinicalTrials.gov Identifier: NCT02223234|
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : January 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Emails and 4 Home Visits Behavioral: Control Behavioral: Emails and 2 home visits||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Guelph Family Health Study: Pilot Study|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: Control
Control- monthly mailed information on children's health
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
- change in adiposity [ Time Frame: baseline, 6 month follow-up ]
- change in body mass index [ Time Frame: baseline, 6-month follow-up ]
- change in waist circumference [ Time Frame: baseline, 6-month follow-up ]
- change in frequency of family meals [ Time Frame: baseline, 6-month follow-up ]
- change in child's sleep duration [ Time Frame: baseline, 6-months ]
- change in child's physical activity [ Time Frame: baseline, 6-months ]
- change in child's fruit and vegetable intake [ Time Frame: baseline, 6-month follow-up ]
- change in child's sugar-sweetened beverage intake [ Time Frame: baseline, 6-month follow-up ]
- change in sedentary behaviour [ Time Frame: baseline, 6-month follow-up ]
- change in child's diastolic blood pressure [ Time Frame: baseline, 6-month follow-up ]
- change in child's biomarkers of diabetes and cardiovascular disease risk [ Time Frame: baseline, 6-month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223234
|Univeristy of Guelph|
|Guelph, Ontario, Canada, N1G 2W1|