- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02939261
Guelph Family Health Study: Full Study (GFHS)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Ontario
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Guelph, Ontario, Канада, N1G 2W1
- Рекрутинг
- Univeristy of Guelph
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Контакт:
- Jess Haines, PhD
- Номер телефона: 53780 519-824-4120
- Электронная почта: jhaines@uoguelph.ca
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Контакт:
- Angela Annis, MSc
- Номер телефона: 56168 519-824-4120
- Электронная почта: aannis@uoguelph.ca
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Главный следователь:
- Jess Haines, PhD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Активный компаратор: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Child - change in BMI
Временное ограничение: Baseline, 6 Months and 18 Months
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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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Child - change in waist circumference
Временное ограничение: Baseline, 6 Months, 18 Months
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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
Временное ограничение: Baseline, 6 Months, 18 Months
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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
Временное ограничение: 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 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
Временное ограничение: 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 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
Временное ограничение: 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).
Временное ограничение: Baseline, 6 Months, 18 Months
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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
Временное ограничение: 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
Временное ограничение: Baseline, 6 Months, 18 Months
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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).
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Baseline, 6 Months, 18 Months
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Adult - change in waist circumference
Временное ограничение: Baseline, 6 Months, 18 Months
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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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Adult - change in % body fat
Временное ограничение: 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
Временное ограничение: 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.
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Baseline, 6 Months, 18 Months
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Adult - change in physical activity
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Jess Haines, PhD, Unviersity of Guelph
- Директор по исследованиям: David Ma, PhD, University of Guelph
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 14AP009
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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