Weigh Easy: Simplifying Home Weight Monitoring for Infants

NCT04384276 | Completed DMC

• 1 other identifier: STUDY00000822
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

This single-site, experimental, pilot study in infants identified from 0 - 3 months of age who present to the Cleft and Craniofacial Clinic with a cleft lip and/or palate will compare weight outcomes of infants who used the Weigh Easy system to monitor weight and historical infants whose weights were monitored without the Weigh Easy system.

Conditions

Cleft Lip and Palate

Keywords

Weight Monitoring

Outcome Measures

Primary Outcomes (3)

• Change in Weight

  Weight will be recorded for the duration of the study to identify points of weight destabilization.

  up to 3 months

• Change in Nutritional Interventions

  Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.

  up to 3 months

• Change in Admissions

  Number of admission due to feeding problems or failure to thrive will be analyzed by comparing the number and frequency of admissions between the retrospective and prospective cohorts.

  up to 3 months

Secondary Outcomes (1)

• Parental Satisfaction: survey

  Month 3

Study Arms (2)

Prospective Weigh Easy

EXPERIMENTAL

Patients enrolled onto this arm of the study will use the Weigh Easy system for weight tracking in the first three months of life. Weights will be measured in home using the Weigh Easy scale and transmitted to the study team via the Weigh Easy eClipboard message. A notification scheme will be activated for weights found to have plateaued or decreased to ensure that the infant's standard of care nutritionist and provider are able to follow up and recommend additional interventions to counteract the weight change. After three months, families will complete a satisfaction survey to determine if the Weigh Easy system was preferable or if there are any improvements that could be made. All other aspects of the patients' care will follow the standard of care for cleft and craniofacial diagnoses and will be guided by the nutritionists specializing in cleft and craniofacial care.

Other: The Weigh Easy System

Retrospective Control Arm

OTHER

Patients enrolled onto the control arm will have retrospectively presented to the Cleft and Craniofacial Clinic from January 1, 2016 to December 31, 2018 as infants. These patients were treated with the standard of care for cleft and craniofacial diagnoses and were followed by the nutritionists specializing in cleft and craniofacial care.

Other: Retrospective Control

Interventions

The Weigh Easy System OTHER

By use of a small user-friendly luggage scale, the family can easily and safely obtain a weight within the comfort of their own home. Using the Weigh Easy eClipboard, a message will be sent to the family on a weekly basis via Cerner's Message Center that will include a link. The link will be used by parents to enter and submit the patient's current weight. Upon submission, the weight will be transmitted into the patient's EMR after it's reviewed and accepted by a member of the study team. When the weight is received in the system, an alert will be triggered that will notify the study team of its arrival. While the Weigh Easy eClipboard function does qualify as a device, as the investigators will be making clinical decisions based off of the data received through the form, the device is not being used investigationally on this study. The eClipboard function is a standard part of the Cerner framework and has been previously investigated and vetted by for safety and efficacy.

Prospective Weigh Easy

Retrospective Control OTHER

No interventions will be administered to the historical control group.

Retrospective Control Arm

Eligibility Criteria

• Age: Up to 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborn patient ≤ 12 weeks old
• Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from December 1, 2019 - November 30, 2020
• With a diagnosis of cleft lip and/or cleft palate
• Male or female infant of any ethnic background

You may not qualify if:

• Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition
• Infant who is placed in foster care prior to or during the applicable study period
• Patient parents unable to complete an electronic survey.
• Patient parents unable to speak and read Spanish or English.
• Retrospective Group:
• Newborn patient ≤ 12 weeks old
• Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from January 1, 2016 to June 30, 2019
• With a diagnosis of cleft lip and/or cleft palate
• Male or female infant of any ethnic background
• Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (19)

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  PMID: 6928113 BACKGROUND

• Barrett, D. E., Radke-Yarrow, M., & Klein, R. E. (1982). Chronic malnutrition and child behavior: Effects of early caloric supplementation on social and emotional functioning at school age. Developmental Psychology, 18(4):541-556. doi:10.1037/0012-1649.18.4.541

  BACKGROUND

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• Idohou-Dossou N, Wade S, Guiro AT, Sarr CS, Diaham B, Cisse D, Beau JP, Chappuis P, Hoffman D, Lemonnier D. Nutritional status of preschool Senegalese children: long-term effects of early severe malnutrition. Br J Nutr. 2003 Dec;90(6):1123-32. doi: 10.1079/bjn2003990.

  PMID: 14641972 BACKGROUND

• Jones WB. Weight gain and feeding in the neonate with cleft: a three-center study. Cleft Palate J. 1988 Oct;25(4):379-84.

  PMID: 3060285 BACKGROUND

• Kaye A, Thaete K, Snell A, Chesser C, Goldak C, Huff H. Initial Nutritional Assessment of Infants With Cleft Lip and/or Palate: Interventions and Return to Birth Weight. Cleft Palate Craniofac J. 2017 Mar;54(2):127-136. doi: 10.1597/15-163. Epub 2016 Feb 16.

  PMID: 26882024 BACKGROUND

• Lao LJ, Zhang LY, DU LZ. [Malnutrition in early life and cardiovascular disease in adulthood]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2015 May;44(3):349-53. doi: 10.3785/j.issn.1008-9292.2015.05.18. Chinese.

  PMID: 26350019 BACKGROUND

• Marques IL, Nackashi JA, Borgo HC, Martinelli AP, Pegoraro-Krook MI, Williams WN, Dutka JC, Seagle MB, Souza TV, Garla LA, Neto JS, Silva ML, Graciano MI, Moorhead J, Piazentin-Penna SH, Feniman MR, Zimmermann MC, Bento-Goncalves CG, Pimentel MC, Boggs S, Jorge JC, Antonelli PJ, Shuster J. Longitudinal study of growth of children with unilateral cleft-lip palate from birth to two years of age. Cleft Palate Craniofac J. 2009 Nov;46(6):603-9. doi: 10.1597/08-105.1. Epub 2009 May 16.

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  PMID: 23439590 BACKGROUND

• Montagnoli LC, Barbieri MA, Bettiol H, Marques IL, de Souza L. Growth impairment of children with different types of lip and palate clefts in the first 2 years of life: a cross-sectional study. J Pediatr (Rio J). 2005 Nov-Dec;81(6):461-5. doi: 10.2223/JPED.1420.

  PMID: 16385363 BACKGROUND

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MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shao Jiang, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: A single experimental group will be enrolled prospectively to use the Weigh Easy system. Due to the potential impacts of weight gain within this patient population and the lifelong implications of early malnutrition, we do not feel we can safely randomize a prospective control group. As a result, a retrospective control group will be enrolled to enable a comparison of outcomes between those families using the Weigh Easy system and those who did not. All patients, both retrospective and prospective, will be treated according to the standard cleft lip and/or palate treatment protocols and followed by the registered nutritionists who routinely participate in the Cleft and Craniofacial Clinic

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: May 12, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)