Weigh Easy: Simplifying Home Weight Monitoring for Infants

January 13, 2023 updated by: Shao Jiang, Children's Mercy Hospital Kansas City

Simplifying Home Weight Monitoring for Infants With Cleft Lip and/or Palate Differences to Determine if Use of an In-home Scale Leads to Better Compliance With Weight Monitoring Recommendations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited at the earliest possible visit to the Cleft and Craniofacial Clinic. At this visit, families will complete the consent process. After consent is obtained, the study team will ensure that the family is signed up for the Patient Portal and will provide a demonstration of how to safely obtain a weight using the Weigh Easy scale and the infant's car seat. In addition to the luggage scale, a handout will also be sent home with the family, including instructions and safety tips for weighing their infant and instructions for submitting a weight via the Patient Portal.

Families will be asked to submit a weight, obtained with the Weigh Easy scale, via the Weigh Easy eClipboard message on a weekly basis for 3 months.

Three months after the family is enrolled onto the study, the family will be provided the Parental Satisfaction Survey to complete. This will occur at a clinic visit, in the event that a standard of care visit occurs within the window for the visit. If a clinic visit is unavailable, the surveys will be emailed to the family and three reminders will be sent if the survey is not completed in a timely manner.

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Prospective Group:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective Weigh Easy

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
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.
Other: Retrospective Control Arm
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
No interventions will be administered to the historical control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weight
Time Frame: up to 3 months
Weight will be recorded for the duration of the study to identify points of weight destabilization.
up to 3 months
Change in Nutritional Interventions
Time Frame: up to 3 months
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
Time Frame: up to 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Satisfaction: survey
Time Frame: Month 3
The Weigh Easy Parental Satisfaction Survey will be used to create a satisfaction score for each family participating. Answers to this survey will be built using a five-point Likert scale. Minimum score: 4, Maximum score: 20, with higher scores indicating lower parental satisfaction. The survey will be administered at a standard of care appointment three months after enrollment (± 1 month) or via email if an appointment is unavailable during this window. This variable will be measured for the prospective cohort only.
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Shao Jiang, MD, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000822

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

De-identified individual patient data only can be shared with other researchers, however the necessary contracting will be needed prior to any data can be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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