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Clinical Trials/NCT02223234
NCT02223234
Completed
Not Applicable

Guelph Family Health Study: Pilot Study

University of Guelph1 site in 1 country44 target enrollmentSeptember 2014
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Guelph
Enrollment
44
Locations
1
Primary Endpoint
change in adiposity
Status
Completed
Last Updated
9 years ago

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:

  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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jess Haines

Associate Professor

University of Guelph

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

Outcomes

Primary Outcomes

change in adiposity

Time Frame: baseline, 6 month follow-up

Secondary Outcomes

  • 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 body mass index(baseline, 6-month follow-up)
  • change in frequency of family meals(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)

Study Sites (1)

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