Guelph Family Health Study: Full Study (GFHS)

University of Guelph

Status: Unknown

Conditions: Obesity

Treatments: Behavioral: Intervention - 4 Home Visits; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02939261

14AP009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 2 patient groups

Control

Active Comparator group

Description:

Families randomized to control will receive monthly emails containing publicly available handouts on general child health.

Treatment:

Behavioral: Control

Intervention - 4 Home Visits

Experimental group

Description:

Families randomized to the intervention will receive: a) 4 home visits from a health educator, b) weekly e-mails, and c) monthly mailed behavioural supports.

Treatment:

Behavioral: Intervention - 4 Home Visits