Weigh Easy: Simplifying Home Weight Monitoring for Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Other: The Weigh Easy System
* Other: Retrospective Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Weigh Easy<br>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<br>* 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.<br>|
| Other: Retrospective Control Arm<br>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<br>* No interventions will be administered to the historical control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Satisfaction: survey | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Monitoring