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Идёт набор NCT03145688

Family Habit Physical Activity Study

Без фазы С лечением Physical Activity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Family Physical Activity Planning, Family Physical Activity Habit Formation.
Кому может быть актуально
Состояния в реестре: Physical Activity. Базовые параметры: 6 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Promoting Habit Formation in Family Physical Activity

Обзор

The purpose of this study is to examine physical activity habit formation in parents and if this can increase moderate to vigorous physical activity behavior in their children over six months. The Primary Research Question is: Does the habit formation condition result in increased moderate-vigorous intensity physical activity of the child compared to the control (education) and education + planning conditions at six months? Hypothesis: Child physical activity will be higher for the habit formation condition in comparison to the more standard physical activity education and planning conditions at six months.

Подробное описание

Secondary Research Questions

1. Does the habit formation condition improve child health-related quality of life, and health-related fitness outcomes compared to the control and planning conditions at six months? Hypothesis: Child health-related fitness and quality of life will be higher for the habit formation condition in comparison to the control and planning conditions. 2. Can group differences among behavioural, and health-related fitness outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (habit formation, planning + education, education control) on child physical activity will be explained by parental support habit, and through the use of consistency and cues regulation strategies (i.e., manipulation check). In turn, the covariance between support habit and health-related outcomes will be explained by physical activity among conditions. The habit formation condition will not affect parental support intentions or underlying outcome expectations (benefits of physical activity) for support of child physical activity because its effect on behavior is to tie initial intentions to behavioural action or to work independent of goals and intentions. 3. Is there an intergenerational, seasonal, or gender difference across primary outcomes by assigned condition? Hypothesis: Parents in the habit formation condition will show higher physical activity via some activities being performed with their children in comparison to the other conditions. No differences in gender or season are hypothesized but these are exploratory research questions because there is limited research at present \[28\] to make any definitive statement.

Вмешательства

  • Поведенческое Family Physical Activity Planning
    Families will receive the same guidelines as the standard education control group but will also be provided with family physical activity planning material. This material will include a skill training content workbook on how to plan for family physical activity. The material includes a brainstorming exercise for parents where they list physical activities they think their children have found fun in the past, as well as activities that they would find enjoyable to do as a family. We will provide
  • Поведенческое Family Physical Activity Habit Formation
    Families will receive the same content as the education control condition and the physical activity planning condition but with additional material on creating physical activity support habits. A key component of the habit section will be based on planning for context-dependent repetition, with pointers on how to maintain repetition as habit forms. The importance of creating cues for parental support of child physical activity is then outlined. Cues will also be considered factors that a) can pr

Первичные конечные точки

  • Change from baseline in children's physical activity to 6 months [Срок оценки: Baseline & 6 months]
Вторичные конечные точки (12)
  • Change from baseline in personal physical activity to six months (child PA) [Срок оценки: Baseline & 6 months]
  • Change from baseline in self-reported family based physical activity to six months [Срок оценки: Baseline & 6 months]
  • Change from baseline in weight at 6 months [Срок оценки: baseline and 6 months]
  • Change from baseline in height at 6 months [Срок оценки: baseline and 6 months]
  • Change from baseline in waist circumference at 6 months [Срок оценки: baseline and 6 months]
  • Change from baseline in BMI at 6 months [Срок оценки: baseline and 6 months]
  • Change from baseline in grip strength at 6 months (MSK fitness) [Срок оценки: baseline and 6 months]
  • Change from baseline in sit and reach flexibility at 6 months [Срок оценки: baseline and 6 months]
  • Change from baseline in plank test time at 6 months [Срок оценки: baseline and 6 months]
  • Change from baseline in cardiovascular fitness at 6 months [Срок оценки: baseline and 6 months]
  • Change from baseline in parent support of child's physical activity at 6 weeks [Срок оценки: baseline and 6 weeks]
  • Change from baseline in parent support of child's physical activity at 3 months [Срок оценки: baseline and 3 months]

Критерии участия

Критерии включения

  • parents with children between the ages of 6 and 12 years
  • self-report low family physical activity
  • target child is not meeting Canada's Physical Activity guidelines

Критерии исключения

  • participant is unsafe to participate in physical activity as determined by answers to the Physical Activity Readiness Questionnaire (PAR-Q)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Канада · 1 центр
  • Behavioural Medicine Lab, University of Victoria — Victoria

Публикации

  • Medd ER, Beauchamp MR, Blanchard CM, Carson V, Gardner B, Warburton DE, Rhodes RE. Family-based habit intervention to promote parent support for child physical activity in Canada: protocol for a randomised trial. BMJ Open. 2020 Apr 14;10(4):e033732. doi: 10.1136/bmjopen-2019-033732. PMID 32295773

Идентификаторы

NCT: NCT03145688 · 35941 51350

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗