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- Register voor klinische proeven in de VS.
- Klinische proef NCT02939261
Guelph Family Health Study: Full Study (GFHS)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ontario
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Guelph, Ontario, Canada, N1G 2W1
- Werving
- Univeristy of Guelph
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Contact:
- Jess Haines, PhD
- Telefoonnummer: 53780 519-824-4120
- E-mail: jhaines@uoguelph.ca
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Contact:
- Angela Annis, MSc
- Telefoonnummer: 56168 519-824-4120
- E-mail: aannis@uoguelph.ca
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Hoofdonderzoeker:
- Jess Haines, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Control
Families randomized to control will receive monthly emails containing publicly available handouts on general child health.
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monthly emails with general health information
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Experimenteel: 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.
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4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Child - change in BMI
Tijdsspanne: 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).
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Baseline, 6 Months and 18 Months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Child - change in waist circumference
Tijdsspanne: 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.
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Baseline, 6 Months, 18 Months
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Child - change in % body fat
Tijdsspanne: 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.
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Baseline, 6 Months, 18 Months
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Child - change in sleep duration
Tijdsspanne: 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.
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Baseline, 6 Months, 18 Months
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Child - change physical activity
Tijdsspanne: 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.
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Baseline, 6 Months, 18 Months
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Child - change in sedentary behaviour
Tijdsspanne: Baseline, 6 Months, 18 Months
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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.
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Baseline, 6 Months, 18 Months
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Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).
Tijdsspanne: 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.
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Baseline, 6 Months, 18 Months
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Adult and child - change in family meals
Tijdsspanne: Baseline, 6 Months, 18 Months
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Parents will report frequency of family meals using an item from The Home Environment Inventory.
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Baseline, 6 Months, 18 Months
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Adult - change in BMI
Tijdsspanne: 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).
|
Baseline, 6 Months, 18 Months
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Adult - change in waist circumference
Tijdsspanne: 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.
|
Baseline, 6 Months, 18 Months
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Adult - change in % body fat
Tijdsspanne: Baseline, 6 Months, 18 Months
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Trained staff will measure parental body composition using air displacement plethysmography, i.e., BODPOD™.
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Baseline, 6 Months, 18 Months
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Adult - change in sleep duration
Tijdsspanne: Baseline, 6 Months, 18 Months
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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
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Adult - change in physical activity
Tijdsspanne: Baseline, 6 Months, 18 Months
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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.
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Baseline, 6 Months, 18 Months
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Adult - change in sedentary behaviour
Tijdsspanne: Baseline, 6 Months, 18 Months
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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.
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Baseline, 6 Months, 18 Months
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Adult - change in dietary behaviour
Tijdsspanne: Baseline, 6 Months, 18 Months
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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.
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Baseline, 6 Months, 18 Months
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Adult - motivation for lifestyle change
Tijdsspanne: Baseline, 6 Months, 18 Months
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Treatment Self-Regulation Questionnaire will be used to assess family level of autonomous motivation.
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Baseline, 6 Months, 18 Months
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Social determinants of obesity
Tijdsspanne: Baseline, 6 Months, 18 Months
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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.
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Baseline, 6 Months, 18 Months
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Cost-effectiveness of Intervention
Tijdsspanne: Baseline, 6 Months, 18 Months
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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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Baseline, 6 Months, 18 Months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jess Haines, PhD, Unviersity of Guelph
- Studie directeur: David Ma, PhD, University of Guelph
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 14AP009
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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