- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02939261
Guelph Family Health Study: Full Study (GFHS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jess Haines, PhD
- Numéro de téléphone: 53780 519-824-4120
- E-mail: jhaines@uoguelph.ca
Sauvegarde des contacts de l'étude
- Nom: Angela Annis, MSc
- Numéro de téléphone: 56168 519-824-4120
- E-mail: aannis@uoguelph.ca
Lieux d'étude
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- Recrutement
- Univeristy of Guelph
-
Contact:
- Jess Haines, PhD
- Numéro de téléphone: 53780 519-824-4120
- E-mail: jhaines@uoguelph.ca
-
Contact:
- Angela Annis, MSc
- Numéro de téléphone: 56168 519-824-4120
- E-mail: aannis@uoguelph.ca
-
Chercheur principal:
- Jess Haines, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Control
Families randomized to control will receive monthly emails containing publicly available handouts on general child health.
|
monthly emails with general health information
|
Expérimental: 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.
|
4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Child - change in BMI
Délai: 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).
|
Baseline, 6 Months and 18 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Child - change in waist circumference
Délai: 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
|
Child - change in % body fat
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Child - change in sleep duration
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Child - change physical activity
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Child - change in sedentary behaviour
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Adult and child - change in family meals
Délai: Baseline, 6 Months, 18 Months
|
Parents will report frequency of family meals using an item from The Home Environment Inventory.
|
Baseline, 6 Months, 18 Months
|
Adult - change in BMI
Délai: 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
|
Adult - change in waist circumference
Délai: 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
|
Adult - change in % body fat
Délai: Baseline, 6 Months, 18 Months
|
Trained staff will measure parental body composition using air displacement plethysmography, i.e., BODPOD™.
|
Baseline, 6 Months, 18 Months
|
Adult - change in sleep duration
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Adult - change in physical activity
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Adult - change in sedentary behaviour
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Adult - change in dietary behaviour
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Adult - motivation for lifestyle change
Délai: Baseline, 6 Months, 18 Months
|
Treatment Self-Regulation Questionnaire will be used to assess family level of autonomous motivation.
|
Baseline, 6 Months, 18 Months
|
Social determinants of obesity
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Cost-effectiveness of Intervention
Délai: 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.
|
Baseline, 6 Months, 18 Months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jess Haines, PhD, Unviersity of Guelph
- Directeur d'études: David Ma, PhD, University of Guelph
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 14AP009
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Control
-
Florida State UniversityMilitary Suicide Research ConsortiumComplétéIdéation suicidaire | Suicide, Tentative | Suicide et automutilation | Automutilation non suicidaireÉtats-Unis
-
Massachusetts General HospitalHarvard University; American Academy of Child Adolescent Psychiatry.InconnueColère | AgressionÉtats-Unis
-
Rethink Medical SLRecrutementQualité de vie | Complication liée au cathéter | Infection des voies urinaires associée au cathéterEspagne
-
Rethink Medical SLRetiréRétention urinaire | Complications du cathéter | Infection des voies urinaires associée au cathéterEspagne
-
King's College Hospital NHS TrustSt George's, University of LondonActif, ne recrute pasHernie diaphragmatique congénitaleRoyaume-Uni
-
Johnson & Johnson Vision Care, Inc.ComplétéCorrection de l'erreur de réfraction | Atténuation de la lumière viveÉtats-Unis
-
University of Southern CaliforniaPendulum TherapeuticsRetiréDiabète de type 2 | Symptômes gastro-intestinauxÉtats-Unis
-
University of Castilla-La ManchaComplétéDouleur au point gâchette, myofascialeEspagne
-
Icahn School of Medicine at Mount SinaiRecrutement
-
University of Castilla-La ManchaComplétéDouleur au point gâchette, myofascialeEspagne