Failure to ThriveNCT02589132
Mobile-Thrive - A Family Self-Management Approach to Failure to Thrive
A study testing Mobile-Thrive application in people with Failure to Thrive, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 months to 4 years
- Conditions the study is for
- Failure to Thrive
- What is being tested?
- Mobile-Thrive application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of children ages 4 months to 4 years old with a medical diagnosis of failure to thrive.
- English speaking.
Who cannot join
- Parents of children who do not meet the inclusion criteria.
- Non- english speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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.
Read the 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.
- Conditions
- Failure to Thrive
- Being tested
- Mobile-Thrive application
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-Thrive applicationOther
Families receive standard of care plus the Mobile-Thrive application
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Families receiving Standard of Care |
| Mobile-Thrive application | Experimental | Standard care plus Mobile-Thrive app Receives: Other: Mobile-Thrive application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight z score
Change in weight as measured by weight z score percentiles
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Failure to ThriveStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute
- Responsible party
- Principal investigator, Praveen Goday, Medical College of Wisconsin
- Investigators
- Praveen Goday, MD, Principal investigator, Medical College of WisconsinAlan Silverman, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589132
- Sponsor's protocol ID
- CHW 15/22
- Status last verified
- Oct 2019
- First submitted
- 3 Sep 2015
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaffe AC. Failure to thrive: current clinical concepts. Pediatr Rev. 2011 Mar;32(3):100-7; quiz 108. doi: 10.1542/pir.32-3-100. No abstract available.
PubMed 21364013Mitchell WG, Gorrell RW, Greenberg RA. Failure-to-thrive: a study in a primary care setting. Epidemiology and follow-up. Pediatrics. 1980 May;65(5):971-7.
PubMed 7367142Berwick DM, Levy JC, Kleinerman R. Failure to thrive: diagnostic yield of hospitalisation. Arch Dis Child. 1982 May;57(5):347-51. doi: 10.1136/adc.57.5.347.
PubMed 6807215Skuse DH. Non-organic failure to thrive: a reappraisal. Arch Dis Child. 1985 Feb;60(2):173-8. doi: 10.1136/adc.60.2.173.
PubMed 3883912Block RW, Krebs NF; American Academy of Pediatrics Committee on Child Abuse and Neglect; American Academy of Pediatrics Committee on Nutrition. Failure to thrive as a manifestation of child neglect. Pediatrics. 2005 Nov;116(5):1234-7. doi: 10.1542/peds.2005-2032.
PubMed 16264015Black MM, Krishnakumar A. Predicting longitudinal growth curves of height and weight using ecological factors for children with and without early growth deficiency. J Nutr. 1999 Feb;129(2S Suppl):539S-543S. doi: 10.1093/jn/129.2.539S.
PubMed 10064327Dowdney L, Skuse D, Morris K, Pickles A. Short normal children and environmental disadvantage: a longitudinal study of growth and cognitive development from 4 to 11 years. J Child Psychol Psychiatry. 1998 Oct;39(7):1017-29.
PubMed 9804034Dykman RA, Casey PH, Ackerman PT, McPherson WB. Behavioral and cognitive status in school-aged children with a history of failure to thrive during early childhood. Clin Pediatr (Phila). 2001 Feb;40(2):63-70. doi: 10.1177/000992280104000201.
PubMed 11261452Drotar D, Sturm L. Prediction of intellectual development in young children with early histories of nonorganic failure-to-thrive. J Pediatr Psychol. 1988 Jun;13(2):281-96. doi: 10.1093/jpepsy/13.2.281. No abstract available.
PubMed 3171820Skuse D, Pickles A, Wolke D, Reilly S. Postnatal growth and mental development: evidence for a "sensitive period". J Child Psychol Psychiatry. 1994 Mar;35(3):521-45. doi: 10.1111/j.1469-7610.1994.tb01738.x.
PubMed 7515070Mendez MA, Adair LS. Severity and timing of stunting in the first two years of life affect performance on cognitive tests in late childhood. J Nutr. 1999 Aug;129(8):1555-62. doi: 10.1093/jn/129.8.1555.
PubMed 10419990Yang S, Tilling K, Martin R, Davies N, Ben-Shlomo Y, Kramer MS. Pre-natal and post-natal growth trajectories and childhood cognitive ability and mental health. Int J Epidemiol. 2011 Oct;40(5):1215-26. doi: 10.1093/ije/dyr094. Epub 2011 Jul 15.
PubMed 21764769Crookston BT, Penny ME, Alder SC, Dickerson TT, Merrill RM, Stanford JB, Porucznik CA, Dearden KA. Children who recover from early stunting and children who are not stunted demonstrate similar levels of cognition. J Nutr. 2010 Nov;140(11):1996-2001. doi: 10.3945/jn.109.118927. Epub 2010 Sep 15.
PubMed 20844188Atalay A, McCord M. Characteristics of failure to thrive in a referral population: implications for treatment. Clin Pediatr (Phila). 2012 Mar;51(3):219-25. doi: 10.1177/0009922811421001. Epub 2011 Oct 12.
PubMed 21997145Garro A, Thurman SK, Kerwin ME, Ducette JP. Parent/caregiver stress during pediatric hospitalization for chronic feeding problems. J Pediatr Nurs. 2005 Aug;20(4):268-75. doi: 10.1016/j.pedn.2005.02.015.
PubMed 16030506
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile-Thrive - A Family Self-Management Approach to Failure to Thrive
- ClinicalTrials.gov ID
- NCT02589132
- Acronym / sponsor ID
- CHW 15/22
- Conditions
- Failure to Thrive
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's National Research Institute
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Families receiving Standard of Care |
| Mobile-Thrive application | Experimental | Other: Mobile-Thrive applicationStandard care plus Mobile-Thrive app |
Who may qualify
- Ages
- 4 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents of children ages 4 months to 4 years old with a medical diagnosis of failure to thrive.
- English speaking.
Key exclusion criteria (2 listed)
- Parents of children who do not meet the inclusion criteria.
- Non- english speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-Thrive applicationFamilies receive standard of care plus the Mobile-Thrive application | Other | Mobile-Thrive application |
Primary outcome
Weight z score
Time frame: 3 months
Change in weight as measured by weight z score percentiles
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Background: PubMed 21364013Jaffe AC. Failure to thrive: current clinical concepts. Pediatr Rev. 2011 Mar;32(3):100-7; quiz 108. doi: 10.1542/pir.32-3-100. No abstract available.
- Background: PubMed 7367142Mitchell WG, Gorrell RW, Greenberg RA. Failure-to-thrive: a study in a primary care setting. Epidemiology and follow-up. Pediatrics. 1980 May;65(5):971-7.
- Background: PubMed 6807215Berwick DM, Levy JC, Kleinerman R. Failure to thrive: diagnostic yield of hospitalisation. Arch Dis Child. 1982 May;57(5):347-51. doi: 10.1136/adc.57.5.347.
- Background: PubMed 3883912Skuse DH. Non-organic failure to thrive: a reappraisal. Arch Dis Child. 1985 Feb;60(2):173-8. doi: 10.1136/adc.60.2.173.
- Background: PubMed 16264015Block RW, Krebs NF; American Academy of Pediatrics Committee on Child Abuse and Neglect; American Academy of Pediatrics Committee on Nutrition. Failure to thrive as a manifestation of child neglect. Pediatrics. 2005 Nov;116(5):1234-7. doi: 10.1542/peds.2005-2032.
- Background: PubMed 10064327Black MM, Krishnakumar A. Predicting longitudinal growth curves of height and weight using ecological factors for children with and without early growth deficiency. J Nutr. 1999 Feb;129(2S Suppl):539S-543S. doi: 10.1093/jn/129.2.539S.
- Background: PubMed 9804034Dowdney L, Skuse D, Morris K, Pickles A. Short normal children and environmental disadvantage: a longitudinal study of growth and cognitive development from 4 to 11 years. J Child Psychol Psychiatry. 1998 Oct;39(7):1017-29.
- Background: PubMed 11261452Dykman RA, Casey PH, Ackerman PT, McPherson WB. Behavioral and cognitive status in school-aged children with a history of failure to thrive during early childhood. Clin Pediatr (Phila). 2001 Feb;40(2):63-70. doi: 10.1177/000992280104000201.
- Background: PubMed 3171820Drotar D, Sturm L. Prediction of intellectual development in young children with early histories of nonorganic failure-to-thrive. J Pediatr Psychol. 1988 Jun;13(2):281-96. doi: 10.1093/jpepsy/13.2.281. No abstract available.
- Background: PubMed 7515070Skuse D, Pickles A, Wolke D, Reilly S. Postnatal growth and mental development: evidence for a "sensitive period". J Child Psychol Psychiatry. 1994 Mar;35(3):521-45. doi: 10.1111/j.1469-7610.1994.tb01738.x.
- Background: PubMed 10419990Mendez MA, Adair LS. Severity and timing of stunting in the first two years of life affect performance on cognitive tests in late childhood. J Nutr. 1999 Aug;129(8):1555-62. doi: 10.1093/jn/129.8.1555.
- Background: PubMed 21764769Yang S, Tilling K, Martin R, Davies N, Ben-Shlomo Y, Kramer MS. Pre-natal and post-natal growth trajectories and childhood cognitive ability and mental health. Int J Epidemiol. 2011 Oct;40(5):1215-26. doi: 10.1093/ije/dyr094. Epub 2011 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Goday, MD principal investigator
Medical College of Wisconsin
Alan Silverman, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-Thrive application in people with Failure to Thrive, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight z score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02589132, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.