An interventional study of Mobile-Thrive application in Failure to Thrive, sponsored by Medical College of Wisconsin. Terminated at 1 site in United States. Open to participants aged 4 Months to 4 Years. Per ClinicalTrials.gov, last updated 2019-10-11.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
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Exclusion Criteria:
Families receiving Standard of Care
Standard care plus Mobile-Thrive app
Other: Mobile-Thrive application
Families receive standard of care plus the Mobile-Thrive application
Weight z score
Change in weight as measured by weight z score percentiles
Time frame: 3 months
Calorie intake
Change in calorie intake
Time frame: 3 months
Ran from Aug 2015 to primary completion in Dec 2016, 16 months.
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This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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