Guelph Family Health Study: Pilot Study
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Sep 2014
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 4, 2017
January 1, 2017
1.5 years
August 20, 2014
January 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
change in adiposity
baseline, 6 month follow-up
Secondary Outcomes (10)
change in body mass index
baseline, 6-month follow-up
change in waist circumference
baseline, 6-month follow-up
change in frequency of family meals
baseline, 6-month follow-up
change in child's sleep duration
baseline, 6-months
change in child's physical activity
baseline, 6-months
- +5 more secondary outcomes
Study Arms (3)
Control
ACTIVE COMPARATORControl- monthly mailed information on children's health
Email and 4 Home Visits
EXPERIMENTALWeekly emails and 4 home visits with a health educator
Email and 2 Home Visits
EXPERIMENTALWeekly emails and 2 home visits
Interventions
Weekly emails and 4 home visits with health educator
Weekly emails and 2 home visits with health educator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy of Guelph
Guelph, Ontario, N1G 2W1, Canada
Related Publications (2)
Krystia O, Ambrose T, Darlington G, Ma DWL, Buchholz AC, Haines J; Guelph Family Health Study. A randomized home-based childhood obesity prevention pilot intervention has favourable effects on parental body composition: preliminary evidence from the Guelph Family Health Study. BMC Obes. 2019 Mar 4;6:10. doi: 10.1186/s40608-019-0231-y. eCollection 2019.
PMID: 30873285DERIVEDHaines J, Douglas S, Mirotta JA, O'Kane C, Breau R, Walton K, Krystia O, Chamoun E, Annis A, Darlington GA, Buchholz AC, Duncan AM, Vallis LA, Spriet LL, Mutch DM, Brauer P, Allen-Vercoe E, Taveras EM, Ma DWL; Guelph Family Health Study. Guelph Family Health Study: pilot study of a home-based obesity prevention intervention. Can J Public Health. 2018 Aug;109(4):549-560. doi: 10.17269/s41997-018-0072-3. Epub 2018 Apr 25.
PMID: 29981086DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 20, 2014
First Posted
August 22, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2016
Study Completion
December 1, 2016
Last Updated
January 4, 2017
Record last verified: 2017-01