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Guelph Family Health Study: Full Study (GFHS)

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ClinicalTrials.gov Identifier: NCT02939261
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jess Haines, University of Guelph

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intervention - 4 Home Visits Behavioral: Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Guelph Family Health Study: Full Study
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

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.




Primary Outcome Measures :
  1. Child - change in BMI [ Time Frame: Baseline, 6 Months and 18 Months ]
    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).


Secondary Outcome Measures :
  1. Child - change in waist circumference [ Time Frame: Baseline, 6 Months, 18 Months ]
    Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.

  2. Child - change in % body fat [ Time Frame: Baseline, 6 Months, 18 Months ]
    Trained staff will use bioelectrical impedance analysis to assess child body composition and use the equation by Kusher to determine % body fat.

  3. Child - change in sleep duration [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  4. Child - change physical activity [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  5. Child - change in sedentary behaviour [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  6. Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc). [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  7. Adult and child - change in family meals [ Time Frame: Baseline, 6 Months, 18 Months ]
    Parents will report frequency of family meals using an item from The Home Environment Inventory.

  8. Adult - change in BMI [ Time Frame: Baseline, 6 Months, 18 Months ]
    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).

  9. Adult - change in waist circumference [ Time Frame: Baseline, 6 Months, 18 Months ]
    Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.

  10. Adult - change in % body fat [ Time Frame: Baseline, 6 Months, 18 Months ]
    Trained staff will measure parental body composition using air displacement plethysmography, i.e., BODPOD™.

  11. Adult - change in sleep duration [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  12. Adult - change in physical activity [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  13. Adult - change in sedentary behaviour [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  14. Adult - change in dietary behaviour [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  15. Adult - motivation for lifestyle change [ Time Frame: Baseline, 6 Months, 18 Months ]
    Treatment Self-Regulation Questionnaire will be used to assess family level of autonomous motivation.

  16. Social determinants of obesity [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.

  17. Cost-effectiveness of Intervention [ Time Frame: Baseline, 6 Months, 18 Months ]
    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.



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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939261


Contacts
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Contact: Jess Haines, PhD 519-824-4120 ext 53780 jhaines@uoguelph.ca
Contact: Angela Annis, MSc 519-824-4120 ext 56168 aannis@uoguelph.ca

Locations
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Canada, Ontario
Univeristy of Guelph Recruiting
Guelph, Ontario, Canada, N1G 2W1
Contact: Jess Haines, PhD    519-824-4120 ext 53780    jhaines@uoguelph.ca   
Contact: Angela Annis, MSc    519-824-4120 ext 56168    aannis@uoguelph.ca   
Principal Investigator: Jess Haines, PhD         
Sponsors and Collaborators
University of Guelph
Investigators
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Principal Investigator: Jess Haines, PhD Unviersity of Guelph
Study Director: David Ma, PhD University of Guelph

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Responsible Party: Jess Haines, Associate Professor/GFHS Associate Director, University of Guelph
ClinicalTrials.gov Identifier: NCT02939261     History of Changes
Other Study ID Numbers: 14AP009
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No