Weigh Easy: Simplifying Home Weight Monitoring for Infants

Not Applicable

Completed

• Conditions: Cleft Lip and Palate
• Interventions: Other: The Weigh Easy System; Other: Retrospective Control

• Registration Number: NCT04384276
• Lead Sponsor: Children's Mercy Hospital Kansas City

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.

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 Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2020-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Prospective Weigh Easy	The Weigh Easy System	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.
Retrospective Control Arm	Retrospective Control	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.

Primary Outcome Measures

Name	Time	Method
Change in Admissions	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.
Change in Weight	up to 3 months	Weight will be recorded for the duration of the study to identify points of weight destabilization.
Change in Nutritional Interventions	up to 3 months	Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.

Secondary Outcome Measures

Name	Time	Method
Parental Satisfaction: survey	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.

Trial Locations

Locations (1)

The Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States