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临床试验/NCT07224412
NCT07224412招募中不适用

Utilizing Digital Health Approaches to Promote Early Childhood Healthy Eating and Activity Behaviors

Cornell University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Recruitment

研究概览

简要总结

The purpose of this pilot study is to assess the feasibility and acceptability of the Know-How program, a 10-week digital intervention for families of young children promoting healthy eating and activity behaviors and environments.

详细描述

The purpose of this pilot study is to assess the feasibility and acceptability of the KnowHow program, a 10-week digital intervention for families of young children promoting healthy eating and activity behaviors and environments. The KnowHow program, which provides parent education on the topics of mindful parenting, healthy eating, and physical literacy, consists of three components: 1) a custom mobile application (app), 2) virtual group discussions, and 3) child-centered support materials mailed to participating families. The study will include an intervention group and a delayed control group. Feasibility of the digital intervention will be assessed at post-test only by recruitment, retention, usability, and acceptability. Implementation outcomes include measures of digital engagement, enactment, and intention to sustain, and will be collected at post-test only. Theoretical mediators include parent self-efficacy and behavioral capability and will be collected pre- and post-test. Behavioral outcomes, also collected at pre- and post-test, include mindful parenting, parent-child feeding practices, and physical activity parenting practices. Study assessments for the theoretical mediators and behavioral outcomes will be collected at Baseline (Time 1, pre-intervention) and at Post-Test (Time 2, post-intervention) at the same time for both groups. No additional assessments will be collected for the delayed control group at the conclusion of implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must have a preschool-aged child (3-5 years) with no disabilities or conditions that impact typical eating and activity behaviors.
  • Adult participants must have access to a smartphone, reliable internet at home, and can make video calls.

排除标准

  • Adults who do not have a child aged 3-5 or child has a disability/condition that impact typical eating and activity behaviors.
  • Technology access is limited.
  • Adults who read, write or speak a language other than English.

研究组 & 干预措施

KnowHow Program

Experimental

Families will participate in the 10-week KnowHow program and will receive/participate in 1) a custom mobile application (app), 2) virtual group discussions, and 3) child-centered support materials

干预措施: KnowHow Program (Behavioral)

Wait List

No Intervention

Families will not receive any intervention during the 10-week study. Families will receive access to the KnowHow app only for 10 weeks at the conclusion of the study.

结局指标

主要结局

Recruitment

时间窗: Baseline (week 0)

Number of completed interest forms resulting in enrollment.

Retention

时间窗: 10 weeks

Proportion of intervention activities (e.g., app modules and assessments) completed.

Usability

时间窗: Post-Intervention (week10)

Mean scores using the System Usability Scale (SUS) to estimate ease of use, complexity, confidence in using, and likelihood of use (scale 0-5, with higher scores indicating higher rankings of usability)

Acceptability

时间窗: 10 weeks

Mean ratings of information helpfulness, goal setting, liking of the program, willingness to recommend, and desire for additional information (scale 0-5, with higher scores indicating higher acceptibility)

Digital Engagement

时间窗: Post-Intervention (week10)

Percentage of participants engaging with the app (i.e., engagement by topic, features, and temporal patterns), and by dosage (i.e., completion rates of modules and within-app activities).

Intention to sustain

时间窗: Post-intervention (week 10)

Qualitatively capture, via individual interviews, intervention strategies relating to target behaviors which were implemented or adopted.

次要结局

  • Mindful Parenting(Baseline (week 0) and Post-Intevention (week 10))
  • Parent-Child Feeding Practices(Baseline (week 0) and Post-Intervention (week 10))
  • Physical Activity Parenting Practices(Baseline (week 0) and Post-Intervention (week 10))
  • Perceived Parenting Self-Efficacy(Baseline (week 0) and Post-Intervention (week 10))
  • Behavioral capability skills(10 weeks)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Laura Bellows

Associate Professor

Cornell University

研究点 (1)

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