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

Failure to Thrive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02589132
• Other study ID #: CHW 15/22
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Failure to Thrive

Intervention

Other:
• Mobile-Thrive application
Families receive standard of care plus the Mobile-Thrive application

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Calorie intake	Change in calorie intake	3 months
Primary	Weight z score	Change in weight as measured by weight z score percentiles	3 months