Clinical trial NCT02939261: Guelph Family Health Study: Full Study
Official title: Guelph Family Health Study: Full Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The investigators primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study will also assess the cost-effectiveness of the intervention from a societal perspective.

Detailed description: The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study also assess the cost-effectiveness of the intervention from a societal perspective.

The investigators will randomly allocate 356 socio-economically diverse Ontario families to receive either: 1) 4 motivational coaching home visits, bi-weekly emails, and mailed behaviour supports (intervention group), or 2) Monthly emails with general health information (control group). Primary and secondary outcomes will be assessed at baseline, post-intervention (6-months), and 18-month follow-up, and data will be analyzed by intention to treat.

This study tests a novel and promising approach to obesity prevention - an approach that engages families at home, where they eat, play, and sleep. The interdisciplinary investigator team has partnered with parents and key knowledge users in public health and primary care to develop this intervention. As a result, this research could provide a sustainable model for early life obesity prevention, leading to long-term improvements in health and reduction in costs to the health system and society as a whole.

Eligibility criteria: Inclusion Criteria:

* families who have at least 1 child age 18 months - 5 years
* families who live in the Guelph area
* families who can respond to English surveys

Exclusion Criteria:

* plan to move away within the next year
* have children with severe health conditions (e.g., cerebral palsy) that prevent participation in study activities.

Primary outcomes:
measure: Child - change in BMI
timeFrame: Baseline, 6 Months and 18 Months
Secondary outcomes:
measure: Child - change in waist circumference
timeFrame: Baseline, 6 Months, 18 Months
measure: Child - change in % body fat
timeFrame: Baseline, 6 Months, 18 Months
measure: Child - change in sleep duration
timeFrame: Baseline, 6 Months, 18 Months
measure: Child - change physical activity
timeFrame: Baseline, 6 Months, 18 Months
measure: Child - change in sedentary behaviour
timeFrame: Baseline, 6 Months, 18 Months
measure: Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult and child - change in family meals
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - change in BMI
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - change in waist circumference
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - change in % body fat
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - change in sleep duration
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - change in physical activity
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - change in sedentary behaviour
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - change in dietary behaviour
timeFrame: Baseline, 6 Months, 18 Months
measure: Adult - motivation for lifestyle change
timeFrame: Baseline, 6 Months, 18 Months
measure: Social determinants of obesity
timeFrame: Baseline, 6 Months, 18 Months
measure: Cost-effectiveness of Intervention
timeFrame: Baseline, 6 Months, 18 Months
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Univeristy of Guelph
state: Ontario
Study officials:
affiliation: Unviersity of Guelph
name: Jess Haines, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Guelph
name: David Ma, PhD
role: STUDY_DIRECTOR
References: