Guelph Family Health Study: Full Study (GFHS)

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Control; Behavioral: Intervention - 4 Home Visits

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.

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 2W1
      • Recruiting
      • Univeristy of Guelph
      • Contact: Jess Haines, PhD; Phone Number: 53780 519-824-4120; Email: jhaines@uoguelph.ca
      • Contact: Angela Annis, MSc; Phone Number: 56168 519-824-4120; Email: aannis@uoguelph.ca
      • Principal Investigator: Jess Haines, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Families randomized to control will receive monthly emails containing publicly available handouts on general child health.	Behavioral: Control; monthly emails with general health information
Experimental: Intervention - 4 Home Visits; 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.	Behavioral: Intervention - 4 Home Visits; 4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child - change in BMI	Trained staff will use standard practices to measure child height to the nearest 0.1 cm with a Shorrboard stadiometer and child weight to the nearest 0.1 kg using a Seca scale. BMI will be the ratio of weight (kg) to the square of standing height (m).	Baseline, 6 Months and 18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child - change in waist circumference	Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.	Baseline, 6 Months, 18 Months
Child - change in % body fat	Trained staff will use bioelectrical impedance analysis to assess child body composition and use the equation by Kusher to determine % body fat.	Baseline, 6 Months, 18 Months
Child - change in sleep duration	Sleep duration will be assessed using the wActiSleep+ Activity Monitor (ActiGraph). Activity monitors will be worn on the child's non-dominant wrist for 7 consecutive days. Sleep measures will be determined using the validated Sadeh algorithm.	Baseline, 6 Months, 18 Months
Child - change physical activity	Physical activity will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for physical activity for preschool children will be used to determine physical activity.	Baseline, 6 Months, 18 Months
Child - change in sedentary behaviour	Sedentary behaviour will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for sedentary behaviour for preschool children will be used to assess sedentary behaviour.	Baseline, 6 Months, 18 Months
Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).	To assess children's dietary intake, parents will be asked record all food and beverages that their child consumes over a 3-days period (2 weekdays and 1 weekend day). Data will be analyzed for energy and nutrient intake via ESHA nutrient analysis software.	Baseline, 6 Months, 18 Months
Adult and child - change in family meals	Parents will report frequency of family meals using an item from The Home Environment Inventory.	Baseline, 6 Months, 18 Months
Adult - change in BMI	Trained staff will use standard practices to measure adult height to the nearest 0.1 cm with a stadiometer and adult weight to the nearest 0.1 kg using a Seca scale. BMI will be the ratio of weight (kg) to the square of standing height (m).	Baseline, 6 Months, 18 Months
Adult - change in waist circumference	Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.	Baseline, 6 Months, 18 Months
Adult - change in % body fat	Trained staff will measure parental body composition using air displacement plethysmography, i.e., BODPOD™.	Baseline, 6 Months, 18 Months
Adult - change in sleep duration	Sleep duration will be assessed using the wActiSleep+ Activity Monitor (ActiGraph). Activity monitors will be worn on the participants non-dominant wrist for 7 consecutive days. Sleep measures will be determined using the a validated Sadeh algorithm.	Baseline, 6 Months, 18 Months
Adult - change in physical activity	Physical activity will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the participant's hip for 7 consecutive days. Validated cut-off values for physical activity will be used to determine physical activity.	Baseline, 6 Months, 18 Months
Adult - change in sedentary behaviour	Sedentary behaviour will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for sedentary behaviour will be used to assess sedentary behaviour.	Baseline, 6 Months, 18 Months
Adult - change in dietary behaviour	To assess parent's dietary intake, parents will complete one 24-hour recall using the Automated Self-Administered 24-hour-Canada (ASA24®) dietary recall system, a web-based tool that collects and codes 24-hour recalls using the Canadian Nutrient File.	Baseline, 6 Months, 18 Months
Adult - motivation for lifestyle change	Treatment Self-Regulation Questionnaire will be used to assess family level of autonomous motivation.	Baseline, 6 Months, 18 Months
Social determinants of obesity	The investigators will assess parental education, marital status, annual household income, parental work patterns, food security, parent perception of neighbourhood safety, and access to grocery stores and indoor and outdoor spaces to be physically active.	Baseline, 6 Months, 18 Months
Cost-effectiveness of Intervention	The cost effectiveness of the study intervention will be assessed from a societal perspective. The direct costs associated with the intervention will be assessed, as well as health services use and indirect patient costs for both intervention and control groups. Direct costs of the intervention will be estimated from process data collected during the intervention. Through surveys at post-intervention, data will also be collected on costs to families for participating in the intervention, including time spent on home visits and other time costs associated with implementing the intervention recommendations. Health services use will be collected from parents and from linkage with administrative datasets (Ontario Health Insurance Plan). Parents will also be asked to report indirect patient costs, including number of missed school/work days.	Baseline, 6 Months, 18 Months

Collaborators and Investigators

• Sponsor: University of Guelph
• Investigators: Principal Investigator: Jess Haines, PhD, Unviersity of Guelph; Study Director: David Ma, PhD, University of Guelph

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 14AP009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No