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Идёт набор NCT06098716

All in the Family: Promoting Family Function Through Physical Activity

Без фазы С лечением Physical Activity Family Functioning

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: Self Regulation, PA Support & Family Social Identity, Education.
Кому может быть актуально
Состояния в реестре: Physical Activity, Family Functioning. 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 →

Обзор

The goal of this trial is to find out whether adding identity-building and self-regulation training to basic healthy-living education helps families with inactive children (ages 6-12) become more cohesive and physically active. The main question it aims to answer is: Does the identity + self-regulation + education program improve family cohesion more than (a) self-regulation + education or (b) education alone? Researchers will compare three groups-identity+self-regulation+education (ID), self-regulation+education (SR), and education-only (ED)-to see which produces the greatest improvements. Participants will: 1. attend three online workshops at baseline plus two booster sessions at 6-week and 3-month with a project coordinator; 2. complete online questionnaires at baseline, 6-week, 3-month, and 6-month; 3. take part in an exit interview at 6 months.

Подробное описание

The primary objective of this study is to test the efficacy of three family physical activity (PA) interventions on a key family functioning outcome-family cohesion-through increased PA in children and parent-child co-PA. Our study tests three intervention conditions: 1) identity (ID; promotion of a PA parenting identities + self-regulation skills + education), 2) self-regulation (SR; promotion of PA parenting self-regulation skills + education) and 3) education (ED; an education about PA control condition). It is hypothesised that (H1): The ID condition will show significantly larger changes in family cohesion compared to the two other conditions after six-months (primary end-point) and (H2): The SR condition will show significantly larger changes in family cohesion compared to the ED control condition after six-months.

There are three secondary objectives for this study. First, this study aims to assess the impact of the three interventions on the remaining family-functioning dimensions-flexibility and organisation-and on behavioural outcomes (child MVPA and parent-child co-PA) at the 6-month end-point. The ID condition is hypothesized to lead to significantly greater increases in family flexibility, family organization, child MVPA and parent-child co-PA compared to the SR and ED conditions after six months (H3), with the SR condition also expected to outperform the ED condition in these PA outcomes (H4).

Second, this study will also investigate whether group differences in child and parent PA and family functioning outcomes can be explained through a mediation model based on the Multi-Process Action Control (M-PAC) framework. It is hypothesized that changes in child MVPA and parent-child co-PA will mediate the relationship between the intervention groups and family functioning outcomes. These changes in PA behaviors are expected to be predicted by alterations in family social identity and parental PA support identity, which will, in turn, be influenced by parental attitudes, perceptions of control (reflective processes), and behavioral self-regulation (regulatory processes) regarding child PA (H5).

Third, the present study will explore the potential moderating effects of seasonal variation, child sex, dual/single-parent status, parent sex and gender, child age, intervention adherence, and the type and format of PA on the primary outcomes across the three intervention conditions. While no specific hypotheses are pre-set for these factors, it is anticipated that participation in PA may decrease during winter due to weather conditions, and single-parent families might face more barriers to parent-child co-PA, leading to lower participation levels. Additionally, the composition and frequency patterns of child MVPA may influence family functioning outcomes differently across the intervention conditions.

Вмешательства

  • Поведенческое Self Regulation
    How to plan for Family PA
  • Поведенческое PA Support & Family Social Identity
    Exercises that strengthen parents' PA-support identity and a shared active-family identity through values reflection, role-modelling, visualization, and visible "active family" cues.
  • Поведенческое Education
    Information about healthy living (e.g., PA, sleep hygiene and healthy eating)

Первичные конечные точки

  • Family cohesion [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
Вторичные конечные точки (4)
  • Family functioning outcomes (i.e., family organisation and flexibility) [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Children's moderate to vigorous physical activity (MVPA) [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Parent-child intergenerational activity measured via parent self-report [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Parental support and M-PAC Constructs [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]

Критерии участия

Критерии включения

Participants will be at least one parent with at least one child between the ages of 6 and 12 years.

Families (parents and/or guardians and children) residing in Canada. Children that participate in <60 minutes/day of moderate to vigorous physical activity (MVPA).

Критерии исключения

If child is meeting the current physical activity guidelines >=60 minutes a day of moderate to vigorous physical activity per day.

If the participant does not pass the Physical Activity Readiness Questionnaire (PARQ) If children's age falls outside the 6-12 year range

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
  • University of Victoria — Victoria

Публикации

  • Lee ASY, Blanchard CM, Beauchamp MR, Carson V, Madigan S, Strachan S, Vanderloo LM, Streight E, Courtnall S, Rhodes RE. Promoting family functioning through physical activity: a randomized trial to evaluate the "All in the Family" program. Trials. 2025 Aug 12;26(1):287. doi: 10.1186/s13063-025-08977-6. PMID 40796896

Идентификаторы

NCT: NCT06098716 · 435-2023-0493

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗