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Guelph Family Health Study: Pilot Study

Guelph Family Health Study: Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02223234
Enrollment
44
Registered
2014-08-22
Start date
2014-09-30
Completion date
2016-12-31
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALEmails and 4 Home Visits

Weekly emails and 4 home visits with health educator

BEHAVIORALControl

Monthly emails on child health

BEHAVIORALEmails and 2 home visits

Weekly emails and 2 home visits with health educator

Sponsors

University of Guelph
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
change in adipositybaseline, 6 month follow-up

Secondary

MeasureTime frame
change in waist circumferencebaseline, 6-month follow-up
change in frequency of family mealsbaseline, 6-month follow-up
change in child's sleep durationbaseline, 6-months
change in child's physical activitybaseline, 6-months
change in body mass indexbaseline, 6-month follow-up
change in child's sugar-sweetened beverage intakebaseline, 6-month follow-up
change in sedentary behaviourbaseline, 6-month follow-up
change in child's diastolic blood pressurebaseline, 6-month follow-up
change in child's biomarkers of diabetes and cardiovascular disease riskbaseline, 6-month follow-up
change in child's fruit and vegetable intakebaseline, 6-month follow-up

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026