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Guelph Family Health Study: Full Study (GFHS)

2018년 9월 18일 업데이트: 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.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

900

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 캐나다
    • Ontario
      • Guelph, Ontario, 캐나다, N1G 2W1
        • 모병
        • Univeristy of Guelph
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Jess Haines, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Control
Families randomized to control will receive monthly emails containing publicly available handouts on general child health.
행동: Control
monthly emails with general health information
실험적: 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.
행동: Intervention - 4 Home Visits
4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Child - change in BMI
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Child - change in waist circumference
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Guelph

수사관

  • 수석 연구원: Jess Haines, PhD, Unviersity of Guelph
  • 연구 책임자: David Ma, PhD, University of Guelph

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 6월 1일

기본 완료 (예상)

2020년 6월 1일

연구 완료 (예상)

2020년 9월 1일

연구 등록 날짜

최초 제출

2016년 10월 13일

QC 기준을 충족하는 최초 제출

2016년 10월 17일

처음 게시됨 (추정)

2016년 10월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 18일

마지막으로 확인됨

2018년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 14AP009

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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