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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Failure to Thrive

Intervention / Treatment
-----------------
* Other: Mobile-Thrive application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children ages 4 months to 4 years old with a medical diagnosis of failure to thrive. English speaking. Exclusion Criteria: Parents of children who do not meet the inclusion criteria. Non- english speaking.

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Families receiving Standard of Care | |
| Experimental: Mobile-Thrive application<br>Standard care plus Mobile-Thrive app | Other: Mobile-Thrive application<br>* Families receive standard of care plus the Mobile-Thrive application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight z score | Change in weight as measured by weight z score percentiles | 3 months |