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Идёт набор NCT07458009

Theory-Based Parenting Intervention for Preschool Children's Health Behaviors

Без фазы С лечением Preschool Children's Health Behaviors Parental Support

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: A 4-week theory-based online intervention targeting parental support.
Кому может быть актуально
Состояния в реестре: Preschool Children's Health Behaviors, Parental Support. Базовые параметры: от 18 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Randomized Controlled Trial of a Theory-Based Intervention to Improve Parental Support for Preschool Children's Health Behaviors

Обзор

The goal of this study is to test whether a 4-week online program can help parents better support health behaviors of their preschool children (aged 3-6 years). Preschool children often rely on their parents to build health behaviors, such as being physically active, limiting screen time, drinking fewer sugar-sweetened beverages, and washing their hands regularly. The main questions this study aims to answer are: Does the program improve parents' motivation, planning, and habits related to supporting their children's health behaviors? Do parents who receive the program provide more support for their children? Do preschool children in the program show improvements in health behaviors? Can improvements explained by changes in parents' psychological factors? Researchers will compare parents who receive the program immediately to parents in a waitlist control group. Participants will: Complete online questionnaires before the program, after the program, and one month later (Intervention group only). Complete eight online sessions over four weeks using a mobile program.

Подробное описание

Background Early childhood is a critical developmental period for establishing long-term health habits. Preschool children have limited capacity for self-regulation and depend heavily on parental guidance to adopt and maintain health behaviors. Therefore, interventions targeting parents may be particularly effective in promoting child health behaviors during this stage.

Previous research has primarily focused on motivational and self-regulatory determinants of parental support behaviors. However, intention-based models often fail to account for automatic processes, such as habit formation, which may contribute to the intention-behavior gap. To address this limitation, the present study integrates motivational, volitional, and automatic processes into a integrated social cognitive framework to better explain parental decision-making in supporting children's health behaviors.

Study Objectives and Hypotheses The primary objective is to evaluate the effectiveness of a 4-week theory-based intervention targeting parental psychological determinants and behavioral outcomes.

It is hypothesized that:

1. Parents in the intervention group will demonstrate greater improvements in motivational variables (e.g., attitudes, perceived norms, self-efficacy), volitional variables (e.g., action planning, coping planning, action control), and habit compared to the waitlist control group. 2. Parents in the intervention group will report greater increases in supporting behaviors, and their children will show greater improvements in health behaviors compared to the waitlist control group. 3. Changes in motivational, volitional, and automatic variables will mediate the relationship between group assignment and behavioral outcomes.

Study Design This study employs a longitudinal two-arm randomized controlled trial design. Participants are randomly assigned to either an intervention group or a waitlist control group.

Assessments are conducted at baseline (T1), post-intervention (T2), and one-month follow-up (T3). The intervention group also provides feedback regarding program experience.

The intervention targets multiple child health behaviors, including physical activity, screen time, sugar-sweetened beverage consumption, and handwashing.

Intervention Overview The intervention consists of eight sessions delivered over four weeks via a mobile program. Each session lasts approximately 20-30 minutes and includes multimedia materials and interactive exercises.

Weeks 1-2 focus on motivational processes (attitudes, perceived norms, self-efficacy, and social support).

Week 3 focuses on volitional processes (action planning, coping planning, and action control).

Week 4 focuses on habit formation, cue-based strategies, and multiple health behaviors.

Behavior change techniques include goal setting, action planning, self-monitoring, prompts/cues, modeling, Information about health consequences, social support and reward.

Statistical Analysis Plan Intervention effects will be examined using 2 (group) × 3 (time) repeated-measures analyses of variance. Significant interaction effects will be followed by simple effects analyses.

To examine mediation, social cognitive variables will be tested as mediators. Group assignment (intervention = 1, control = 0) will serve as the independent variable, and parental support and child health behaviors will serve as dependent variables. Separate mediation analyses will be conducted for each mediator.

Вмешательства

  • Поведенческое A 4-week theory-based online intervention targeting parental support
    The intervention consists of eight sessions delivered over four weeks via a mobile program. Each session lasts approximately 20-30 minutes and includes multimedia materials and interactive exercises.

Первичные конечные точки

  • Mean score on the Parental Support for Child Physical Activity Scale [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Mean score on the Parental Support for Child Screen Time Reduction Scale [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Mean score on the Parental Support for Child Handwashing Scale [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Mean score on the Parental Support for Sugar-Sweetened Beverage Reduction Scale [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Average daily outdoor physical activity time of the child (hours/day) [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Average daily child screen time (hours/day) [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Mean score on the Child Handwashing Behavior Scale [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Frequency of child sugar-sweetened beverage consumption [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
Вторичные конечные точки (10)
  • Parental Attitude Toward Supporting Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Subjective Norm Toward Supporting Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Parental Self-Efficacy for Supporting Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Perceived Social Norm Supporting Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Social Support for Parental Support Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Behavioral Intention to Support Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Action Planning for Supporting Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Coping Planning for Supporting Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Action Control for Supporting Child Health Behaviors [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]
  • Behavioral Automaticity of Parental Support [Срок оценки: Baseline, post-intervention (4 weeks), and 1-month follow-up]

Критерии участия

Критерии включения

  • Parent of at least one child aged 3-6 years
  • Living in the same household as the child
  • Aged 18 years or older
  • Able to read and understand Chinese
  • Willing to participate in a 4-week online intervention program

Критерии исключения

  • Self-reported diagnosis of a severe psychiatric disorder that may interfere with participation
  • Cognitive impairment or language difficulties that prevent comprehension of study materials or completion of questionnaires
  • Currently participating in another structured parenting or health behavior intervention program

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Department of Psychology, Sun Yat-Sen University — Гуанчжоу

Публикации

  • Kokai LL, O Ceallaigh DT, Wijtzes AI, Roeters van Lennep JE, Hagger MS, Cawley J, Rohde KIM, van Kippersluis H, Burdorf A. Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be). BMJ Open. 2022 Jan 7;12(1):e053711. doi: 10.1136/bmjopen-2021-053711. PMID 34996794

Идентификаторы

NCT: NCT07458009 · 202601200451

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗