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

Primary Purpose

Failure to Thrive

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile-Thrive application
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failure to Thrive

Eligibility Criteria

4 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Mobile-Thrive application

Arm Description

Families receiving Standard of Care

Standard care plus Mobile-Thrive app

Outcomes

Primary Outcome Measures

Weight z score
Change in weight as measured by weight z score percentiles

Secondary Outcome Measures

Full Information

First Posted
September 3, 2015
Last Updated
October 9, 2019
Sponsor
Medical College of Wisconsin
Collaborators
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02589132
Brief Title
Mobile-Thrive - A Family Self-Management Approach to Failure to Thrive
Official Title
Mobile-Thrive - A Family Self-Management Approach to Failure to Thrive
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's National Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Thrive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Families receiving Standard of Care
Arm Title
Mobile-Thrive application
Arm Type
Experimental
Arm Description
Standard care plus Mobile-Thrive app
Intervention Type
Other
Intervention Name(s)
Mobile-Thrive application
Intervention Description
Families receive standard of care plus the Mobile-Thrive application
Primary Outcome Measure Information:
Title
Weight z score
Description
Change in weight as measured by weight z score percentiles
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Calorie intake
Description
Change in calorie intake
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Praveen Goday, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Silverman, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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

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