Guelph Family Health Study: Full Study

Obesity Clinical Trial

— GFHS  

Official title:

Guelph Family Health Study: Full Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02939261
• Other study ID #: 14AP009
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: September 2020

Study information

• Verified date: September 2018
• Source: University of Guelph
• Contact: Jess Haines, PhD
• Phone: 519-824-4120
• Email: jhaines[@]uoguelph.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Intervention - 4 Home Visits
4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.
• Control
monthly emails with general health information

Locations

Country	Name	City	State
Canada	Univeristy of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adult - change in % body fat	Trained staff will measure parental body composition using air displacement plethysmography, i.e., BODPOD™.	Baseline, 6 Months, 18 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adult - motivation for lifestyle change	Treatment Self-Regulation Questionnaire will be used to assess family level of autonomous motivation.	Baseline, 6 Months, 18 Months
Secondary	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
Secondary	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