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Guelph Family Health Study: Full Study (GFHS)

18 de setembro de 2018 atualizado 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Antecipado)

900

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
    • Ontario
      • Guelph, Ontario, Canadá, N1G 2W1
        • Recrutamento
        • Univeristy of Guelph
        • Contato:
        • Contato:
        • Investigador principal:
          • Jess Haines, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

1 ano e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Control
Families randomized to control will receive monthly emails containing publicly available handouts on general child health.
Comportamental: 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.
Comportamental: Intervention - 4 Home Visits
4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Child - change in BMI
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Child - change in waist circumference
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Guelph

Investigadores

  • Investigador principal: Jess Haines, PhD, Unviersity of Guelph
  • Diretor de estudo: David Ma, PhD, University of Guelph

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2017

Conclusão Primária (Antecipado)

1 de junho de 2020

Conclusão do estudo (Antecipado)

1 de setembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

13 de outubro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de outubro de 2016

Primeira postagem (Estimativa)

20 de outubro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de setembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de setembro de 2018

Última verificação

1 de setembro de 2018

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 14AP009

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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