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Guelph Family Health Study: Full Study (GFHS)

18 de septiembre de 2018 actualizado por: Jess Haines, University of Guelph
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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

900

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Ontario
      • Guelph, Ontario, Canadá, N1G 2W1
        • Reclutamiento
        • Univeristy of Guelph
        • Contacto:
          • Jess Haines, PhD
          • Número de teléfono: 53780 519-824-4120
          • Correo electrónico: jhaines@uoguelph.ca
        • Contacto:
          • Angela Annis, MSc
          • Número de teléfono: 56168 519-824-4120
          • Correo electrónico: aannis@uoguelph.ca
        • Investigador principal:
          • Jess Haines, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

1 año y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control
Families randomized to control will receive monthly emails containing publicly available handouts on general child health.
Conductual: 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.
Conductual: Intervention - 4 Home Visits
4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child - change in BMI
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child - change in waist circumference
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Guelph

Investigadores

  • Investigador principal: Jess Haines, PhD, Unviersity of Guelph
  • Director de estudio: David Ma, PhD, University of Guelph

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2017

Finalización primaria (Anticipado)

1 de junio de 2020

Finalización del estudio (Anticipado)

1 de septiembre de 2020

Fechas de registro del estudio

Enviado por primera vez

13 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

17 de octubre de 2016

Publicado por primera vez (Estimar)

20 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de septiembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2018

Última verificación

1 de septiembre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 14AP009

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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