Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)
Phase: NA
Conditions: Obesity, Maternal, Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Diabetes, Overweight
Sponsor: University of Pittsburgh

 
 
 
 
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health 
of Mothers and Young Children (NCT05473767) 
Study Protocol 
University Of Pittsburgh IRB STUDY22020096 Approved 4/5/2022 
 
 

 
At Magee, based on medical records, pregnant and postpartum women meeting the study 
eligibility criteria will be asked to join the study. Following enrollment, mothers will be 
randomized to one of two groups: FCU-Heart (intervention) or FCU Alone (usual care 
comparison). The FCU begins with an assessment of parent-child interaction quality, 
caregiver psychological resources and support, and child risk/promotive factors. FCU 
assessments are typically one hour in length; using only 30 minutes to complete the FCU 
alone ecological assessment provides another 30 minutes for evaluating maternal and 
infant CVH.  
 
Intervention: A Family Check-Up family coach will meet with families for a “check-up” 
about the child’s development and behavior and how to improve their own well-being to 
support the child’s development. The Family Check-Up typically takes place over the 
course of 3-5 sessions, each about an hour long. These meetings take place at home or 
wherever is most convenient including virtually online. 
• First, a trained Family Check-Up family coach will conduct an “Initial Interview.”  
The second step is completing questionnaires about the child and family 
relationships and social support. An important part of this second step is the family 
interaction tasks, where mother and child will take part in activities like playing 
together with toys and puzzles. The Family Check-Up family coach will then 
highlight parenting strengths during the third meeting, called the Feedback Session.  
• Assessments also include measurement of your blood pressure, body mass index, 
diet quality, exercise, smoking. 
During the Feedback Session, the Family Check-Up family coach will meet with you 
for a conversation about strengths and challenges for your child and family as a 
whole. You’ll be invited to set goals for you and your child to support and maintain 
strengths, and to address any areas of concern.  
• After the Feedback Session families have the option to continue meeting with your 
family coach to support the child’s development and improve parental well-being. 
Participants randomly selected to participate in the Family Check-Up Heart program 
will also receive information about healthy eating and weight loss, stress management, 
and smoking and to monitor weight and blood pressure. ENRICH foundational modules 
will be incorporated as appropriate.  
 
Maternal CVH: BP and BMI will be assessed using validated Bluetooth devices and 
following standardized research protocols. Diet quality will be assessed using the Rapid 

Eating Assessment for Participants (REAP-S). Physical activity in mothers will be 
assessed using (1) the Pregnancy physical activity questionnaire (PPAQ), which 
measures active and sedentary behavior and (2) bluetooth data from Fitbit devices 
using standardized research protocols. Smoking will be assessed via questionnaire. 
These measures allow feedback by the family coaches.  
 
The blood pressure and weight data measured by the iHealth devices is transmitted via 
Bluetooth to the participant’s personal device and loaded into the installed iHealth app. 
From there, the iHealth app securely transmits the BP data to the participant's iHealth 
cloud account. Our team will make API requests to download the data from the iHealth 
cloud to a secure UPMC server and upload it to a REDCap database. The same process 
will be used to collect Fitbit activity data from the Fitbit app and cloud account. Data 
transfer over the internet using either the iHealth Cloud API, the Fitbit API, or the 
REDCap API is secure and encrypted (using the HTTPS protocol). The iHealth and Fitbit 
cloud data access are authorized at the time of recruitment and are valid for one year. 
The participant is also able to revoke the access anytime in her iHealth cloud account 
or the Fitbit cloud account. 
 
Outcomes CVH assessments at 6 months will be conducted remotely when possible 
for the FCU Alone control group. Control group participants will be sent a body weight 
scale and BP cuff when they are due for their 6 month measurements. After they receive 
them, staff will facilitate the measurements virtually and let them keep the devices. We 
will do in person assessments only as needed, and will provide the scales and BP cuffs 
to keep at study conclusion.  
 
All participants will be given a handout from NHLBI (uploaded in local supporting 
documents section) at the study conclusion after they complete the 6-month 
outcomes assessment. They will also be provided with the American Heart 
Association's web page that addresses understanding blood pressure readings. If the 
outcome readings are elevated or high, they will also be advised to consult with their 
doctor.  
 
Child CVH will be assessed with BP and BMI. BP will be measured following a 
standardized research protocol using a pediatric-sized cuff.  
 
Implementation measures. We will assess the implementation of the FCU-Heart by 
collecting data on key implementation measures based on  
modified FRAME-IT model for early intervention (includes feasibility, reach, 

acceptability, maintenance, equity, implementation, and tailorability). At the 
completion of the FCU and FCU-Heart interventions (6 months), participants will 
complete a brief acceptability and satisfaction survey, including the Working Alliance 
Inventory. We will conduct qualitative interviews with FCU-Heart family coaches to 
assess their perspectives on feasibility, appropriateness of the intervention, and 
barriers/facilitators of implementation. Program enrollment and completion of sessions 
will be used to assess feasibility and family engagement. The digital literacy scale will 
also be administered at 6 months to test whether this construct has an impact on 
overall engagement in intervention or on engaging in remote/virtual intervention 
sessions vs in person.  
 
All participants in both groups will receive referral for additional services based on 
needs identified during the FCU (e.g., developmental services/ Early Intervention, 
parent/child mental health). In addition, we will communicate findings from 
assessments performed as part of the FCU and facilitate communication with pediatric 
providers and/or referrals following the Pitt pediatric teams’ routine practice. 
Participants in the control group who are identified as having elevated blood pressure 
will be given a handout from NHLBI (uploaded in local supporting documents section) 
and will be advised to consult with their doctor.  
 
Protected health information (PHI) will be collected for the proposed research project. 
Participants will be asked to provide access to their electronic medical records (EMRs) 
and their child’s electronic medical record (EMR) during the informed consent process. 
Upon enrollment in the study, all participants will be assigned a unique study identifier; 
this study ID is used in place of identifying PHI on all study documents with the 
exception of the informed consent form. 
 
After a participant gives birth, the study team will mail a greeting card congratulating 
them on the birth of their baby. 
 
In the event that a participant loses their pregnancy or their infant, the study team will 
send a greeting card expressing sympathy and offering referrals to grief support, if 
desired. The participant will be withdrawn from the study.