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

NCT02589132 | Terminated

• 1 other identifier: CHW 15/22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Failure to Thrive

Outcome Measures

Primary Outcomes (1)

• Weight z score

  Change in weight as measured by weight z score percentiles

  3 months

Other Outcomes (1)

• Calorie intake

  3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Families receiving Standard of Care

Mobile-Thrive application

EXPERIMENTAL

Standard care plus Mobile-Thrive app

Other: Mobile-Thrive application

Interventions

Mobile-Thrive application OTHER

Families receive standard of care plus the Mobile-Thrive application

Mobile-Thrive application

Eligibility Criteria

• Age: 4 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents of children ages 4 months to 4 years old with a medical diagnosis of failure to thrive.
• English speaking.

You may not qualify if:

• Non- english speaking.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's National Research Institute: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (30)

• 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.

  PMID: 21364013 BACKGROUND

• Mitchell 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.

  PMID: 7367142 BACKGROUND

• Berwick 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.

  PMID: 6807215 BACKGROUND

• Skuse DH. Non-organic failure to thrive: a reappraisal. Arch Dis Child. 1985 Feb;60(2):173-8. doi: 10.1136/adc.60.2.173.

  PMID: 3883912 BACKGROUND

• Block 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.

  PMID: 16264015 BACKGROUND

• Black 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.

  PMID: 10064327 BACKGROUND

• Dowdney 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.

  PMID: 9804034 BACKGROUND

• Dykman 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.

  PMID: 11261452 BACKGROUND

• Drotar 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.

  PMID: 3171820 BACKGROUND

• Skuse 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.

  PMID: 7515070 BACKGROUND

• Mendez 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.

  PMID: 10419990 BACKGROUND

• Yang 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.

  PMID: 21764769 BACKGROUND

• Crookston 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.

  PMID: 20844188 BACKGROUND

• Atalay 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.

  PMID: 21997145 BACKGROUND

• Garro 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.

  PMID: 16030506 BACKGROUND

• Rumberger JS, Dansky K. Is there a business case for telehealth in home health agencies? Telemed J E Health. 2006 Apr;12(2):122-7. doi: 10.1089/tmj.2006.12.122.

  PMID: 16620166 BACKGROUND

• Gazmararian JA, Elon L, Yang B, Graham M, Parker R. Text4baby program: an opportunity to reach underserved pregnant and postpartum women? Matern Child Health J. 2014 Jan;18(1):223-232. doi: 10.1007/s10995-013-1258-1.

  PMID: 23494485 BACKGROUND

• Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: background and perspectives on context, process, and outcomes. Nurs Outlook. 2009 Jul-Aug;57(4):217-225.e6. doi: 10.1016/j.outlook.2008.10.004.

  PMID: 19631064 BACKGROUND

• Black MM, Dubowitz H, Hutcheson J, Berenson-Howard J, Starr RH Jr. A randomized clinical trial of home intervention for children with failure to thrive. Pediatrics. 1995 Jun;95(6):807-14.

  PMID: 7539121 BACKGROUND

• Black MM, Dubowitz H, Krishnakumar A, Starr RH Jr. Early intervention and recovery among children with failure to thrive: follow-up at age 8. Pediatrics. 2007 Jul;120(1):59-69. doi: 10.1542/peds.2006-1657.

  PMID: 17606562 BACKGROUND

• Hutcheson JJ, Black MM, Talley M, Dubowitz H, Howard JB, Starr RH Jr, Thompson BS. Risk status and home intervention among children with failure-to-thrive: follow-up at age 4. J Pediatr Psychol. 1997 Oct;22(5):651-68. doi: 10.1093/jpepsy/22.5.651.

  PMID: 9383928 BACKGROUND

• Raynor P, Rudolf MC, Cooper K, Marchant P, Cottrell D. A randomised controlled trial of specialist health visitor intervention for failure to thrive. Arch Dis Child. 1999 Jun;80(6):500-6. doi: 10.1136/adc.80.6.500.

  PMID: 10331996 BACKGROUND

• Wright CM, Callum J, Birks E, Jarvis S. Effect of community based management in failure to thrive: randomised controlled trial. BMJ. 1998 Aug 29;317(7158):571-4. doi: 10.1136/bmj.317.7158.571.

  PMID: 9721113 BACKGROUND

• Rotheram-Borus MJ, Tomlinson M, Swendeman D, Lee A, Jones E. Standardized functions for smartphone applications: examples from maternal and child health. Int J Telemed Appl. 2012;2012:973237. doi: 10.1155/2012/973237. Epub 2012 Dec 13.

  PMID: 23304136 BACKGROUND

• Klesges RC, Klesges LM, Brown G, Frank GC. Validation of the 24-hour dietary recall in preschool children. J Am Diet Assoc. 1987 Oct;87(10):1383-5.

  PMID: 3655169 BACKGROUND

• Berlin KS, Davies WH, Silverman AH, Rudolph CD. Assessing family-based feeding strategies, strengths, and mealtime structure with the Feeding Strategies Questionnaire. J Pediatr Psychol. 2011 Jun;36(5):586-95. doi: 10.1093/jpepsy/jsp107. Epub 2009 Dec 7.

  PMID: 19995867 BACKGROUND

• Davies WH, Satter E, Berlin KS, Sato AF, Silverman AH, Fischer EA, Arvedson JC, Rudolph CD. Reconceptualizing feeding and feeding disorders in interpersonal context: the case for a relational disorder. J Fam Psychol. 2006 Sep;20(3):409-17. doi: 10.1037/0893-3200.20.3.409.

  PMID: 16937997 BACKGROUND

• Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. doi: 10.1186/1477-7525-2-55.

  PMID: 15450120 BACKGROUND

• Panepinto JA, Hoffmann RG, Pajewski NM. A psychometric evaluation of the PedsQL Family Impact Module in parents of children with sickle cell disease. Health Qual Life Outcomes. 2009 Apr 16;7:32. doi: 10.1186/1477-7525-7-32.

  PMID: 19371442 BACKGROUND

• Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62. doi: 10.1093/jpepsy/26.3.155.

  PMID: 11259517 BACKGROUND

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Praveen Goday, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Alan Silverman, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: October 28, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 11, 2019

Record last verified: 2019-10

Locations

US (1)