跳至主要内容
临床试验/NCT02589132
NCT02589132终止不适用

Mobile-Thrive - A Family Self-Management Approach to Failure to Thrive

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Weight z score

研究概览

简要总结

Failure to Thrive negatively affects growth, cognition, behavior, and quality of life (QoL), which can be devastating and enduring. These outcomes are high-cost and lead to increased family stress and negatively affect the caregiver-child relationship. Therefore, families need increased access to materials that will help them understand their child's health and help them use new feeding behaviors to improve the child's nutrition and growth. Standard care with the addition of Mobile Thrive (M-Thrive), our innovative smart phone-based mobile app, is intended to demonstrate the clinical advantages of using mobile health technology (mHealth) in comparison to standard care alone.

详细描述

Families will be randomly assigned to either the Standard Care plus access to the Mobile-Thrive (M-Thrive) application or Standard Care alone. All families will complete a 24-hour dietary recall, Feeding Strategies Questionnaire (FSQ), PedsQL Family Impact Module (PedsQL FIM), and Pediatric Inventory for Parents (PIP) at pre/post treatment. It will take about 45 minutes to complete these measures. Anthropometric measurements will be collected at pretreatment, 6 weeks, and 3 months. Families receiving standard care alone will have regularly scheduled visits in the Nutritional Care Program and will have access to standard care resources, including phone contacts and electronic access through the CHW hospital portal. Specifically, standard care treatment provides dietary and behavioral instructions on appropriate beverage intake, appropriate feeding regimen, advice on limiting low-calorie foods, and multivitamin supplementation, if appropriate. Families in the standard care plus the M-Thrive application will receive the standard care treatment that is described above, as well as on-demand resources, daily educational text messages, and family self-management push notifications through the M-Thrive application. The research team will train families on the use of the M-Thrive application and families in the standard care plus M-Thrive application can contact their provider through the application with questions and/or concerns. At the conclusion of the intervention, qualitative data regarding the participants' experience will be collected. Specifically, 90-minute focus group sessions will occur within 2 weeks of concluding the 3 month active phase of treatment. Families will be asked to discuss factors that affected their ability to sustain condition management recommendations, their efforts to access health care resources, factors that affect family quality of life and caregiver stress, and family impressions of what else would help to build support for families managing FTT. All sessions will be transcribed and coded for content analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
4 Months 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parents of children ages 4 months to 4 years old with a medical diagnosis of failure to thrive.
  • English speaking.

排除标准

  • Parents of children who do not meet the inclusion criteria.
  • Non- english speaking.

研究组 & 干预措施

Mobile-Thrive application

Experimental

Standard care plus Mobile-Thrive app

干预措施: Mobile-Thrive application (Other)

Standard of Care

No Intervention

Families receiving Standard of Care

结局指标

主要结局

Weight z score

时间窗: 3 months

Change in weight as measured by weight z score percentiles

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Praveen Goday

Professor

Medical College of Wisconsin

研究点 (2)

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