Mobile Integrated Care for Childhood Obesity
Phase: NA
Conditions: Obesity
Sponsor: Nemours Children's Health System

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mobile Integrated Care for Childhood Obesity 
 
Study Proposal 
 
NCT05936385 
 
Document last updated May 30, 2025 (only addition of cover letter and enrollment end date) 
 
Last IRB approval October 30, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RESEARCH STRATEGY 
A. SIGNIFICANCE 
A.1 BACKGROUND 
Obesity is a significant public health problem affecting nearly 1 in 5 children in this country. Children of 
racial and ethnic minority groups, of low socioeconomic status, and living in rural communities continue 
to have the highest rates of obesity.1-3 Obesity increases a child’s risk for health conditions, including diabetes, 
cardiovascular disease, pulmonary disease, and orthopedic problems.4-5  Children with obesity are at increased 
risk for mental health problems and experience reduced quality of life6-7 and obesity in adulthood, all contributing 
to significant healthcare utilization and costs.4-5  
Lifestyle behavior interventions are the cornerstone of treatment for childhood obesity, but this 
approach only addresses one aspect of this complex condition. Family, community, and sociodemographic 
factors are equally important to address.17 Families from rural and underserved communities experience barriers 
to engaging in healthy lifestyle behaviors, including challenges affording and accessing nutritious food, lack of 
safe opportunities and spaces for physical activity, and stressed home environments and also may have 
difficulties accessing obesity interventions due to transportation obstacles, time and competing priorities, or 
reduced access to healthcare generally.8-22  Failing to adequately target these barriers may help to explain why 
obesity interventions have not been as successful in these populations, exacerbating existing disparities.8-10 
Dietz and colleagues have a framework that emphasizes the need to integrate community systems with 
healthcare delivery to improve obesity care and reduce disparities (Figure 2).27 Within this framework, 
community systems provide resources to facilitate healthy behaviors and healthcare systems provide 
multidisciplinary care, leveraging information technology to support clinical decision-making and facilitate self-
management. These systems inform and interact with one another, leading to productive interactions between 
families and healthcare providers, a supportive community environment, and tools for self-management to 
engage and empower families. 
A.2 RIGOR OF PRIOR RESEARCH 
Previous studies evaluating integrated interventions to address obesity have gaps in approach, 
including inattention to psychosocial determinants, lack of robust community engagement, and failure 
to target rural populations. Taveras et al. conducted a study enhancing primary care management of children 
with obesity at six primary care sites in Massachusetts using a neighborhood resource guide to community-
based lifestyle programs and text messaging to support lifestyle behavior change.33 Armstrong et al. combined 
physical activity opportunities through recreational facilities in North Carolina with multidisciplinary obesity 
treatment.34 Families in both studies reported improved health behaviors, but effects on weight were small or 
non-significant. These studies did not address psychosocial determinants of obesity or engage communities 
beyond referral to community-based lifestyle programs. Scientific mentorship team member Eneli has 
established the Primary Care Obesity Network in Ohio, a model for integrating obesity care into the medical 
home and creating patient-centered neighborhoods.35 Children who received integrated obesity care through the 
network demonstrated successful weight outcomes, but there were challenges in sustaining aspects of the 
network, underscoring the importance of engaging families, practices, and communities in developing and 
sustaining integrated care systems. 
A.3 PRELIMINARY WORK 
Our research team has demonstrated the importance of addressing psychosocial determinants of health 
among families of children with obesity. The research project leader’s (RPL) Academic Pediatric Association 
Research in Academic Pediatrics Initiative on Diversity Award study of children ages 4-12 years seeking 
treatment in the Nemours Weight Management Clinic found that families with moderate-high psychosocial risk, 
especially related to financial difficulties and caregiver and child mental health problems, were three times more 
likely to be lost to follow-up or not have a meaningful decrease in weight. Families who received psychological 
counseling were twice as likely to remain in obesity treatment.11 Analyzing data on >7000 children in the National 
Health and Nutrition Examination Survey database, we found that children with severe obesity were two times 
more likely to be of a racial or ethnic minority backgrounds, from single-parent households, or from households 
experiencing poverty.3 Finally, in a survey of over 200 families of overweight children under age 5 from a 
Nemours primary care clinic, 85% endorsed one or more psychosocial needs.21 Our qualitative research,22 
coupled with work by the Nemours Value Based Services Organization with 450 families across Delaware, led 
to the development of a 13-item literacy-sensitive, family-friendly psychosocial needs screener, incorporating 
items from validated measures and feedback from families.   

Preliminary data from the RPL’s K23 show that self-management tools keep families engaged in obesity 
treatment.  Driven by our previous work demonstrating that parents with higher psychosocial risk report lower 
self-efficacy managing their child’s behaviors,36-37 we developed and tested a video-based parenting intervention 
for families of children ages 4-12 with obesity.32 Qualitative interviews with caregivers produced three themes 
that informed design of the intervention and this proposed project: the value of hearing from other families of 
children with obesity of diverse backgrounds, the importance of choice and convenience in how the intervention 
is delivered, and the need to be activated. The intervention has been tested in a pilot RCT with 120 families 
attending the Nemours Healthy Weight and Wellness Clinic, with preliminary data showing improved short-term 
visit adherence among families who viewed the videos. 
Our team has spearheaded studies demonstrating the value of telehealth in improving the reach of 
childhood obesity care. A survey of 159 Nemours pediatric primary care providers (PCP) demonstrated their 
desire to connect families with community resources and have obesity specialists accessible by telehealth.26 We 
presented findings from 85 telehealth visits with the Nemours Healthy Weight and Wellness Clinic among families 
in rural Delaware. Not only did 100% of families surveyed report that telehealth visits were more convenient, but 
no-show rates were significantly lower than in-person visits.31 We also conducted a pilot RCT with 45 
adolescents, which found that integrating telehealth visits with obesity specialists between primary care visits 
was linked to better weight outcomes.28 Finally, Dr. Phan and Dr. Davis have demonstrated the effectiveness of 
iAmHealthy, a family-based behavioral group treatment delivered via telehealth, in the IDeA States Pediatric 
Clinical Trials Network (ISPCTN).38-40  
A.4 PROPOSED PROJECT 
Based on our preliminary work and the 
Clinical-Community Integration Frame-
work, 
we 
have 
developed 
Mobile 
Integrated Care for Childhood Obesity 
(MICCO, Figure 2). MICCO is an evidence-
based, multi-component intervention that 
combines integrated community care to ad-
dress psychosocial needs, multidisciplinary 
obesity care, and self-management tools to 
promote healthy lifestyle behaviors. All 
components are delivered through a single 
mobile platform to increase accessibility for 
underserved populations and are integrated into the patient-centered medical home through the mobile 
platform’s integration with the EHR. Aim 1: Community-engaged and qualitative research methods will be used 
to refine MICCO and ensure it is community-centered and family-friendly.  Aims 2 and 3: MICCO will then be 
tested in a RCT with families of children with obesity from rural primary care practices to examine its impact on 
family engagement in treatment, child weight status and disparities in these outcomes. 
B. INNOVATION 
Because attrition is one of the most challenging problems in obesity treatment, developing and testing 
interventions that increase family engagement is critical.  MICCO will change practice paradigms by combining 
and delivering evidence-based interventions in an innovative way, leveraging technology, the patient-centered 
medical home, and the community to increase engagement and sustainability beyond the clinical trial.   
B.1 MICCO will address psychosocial determinants of health to reduce disparities in childhood obesity 
outcomes. Most childhood obesity interventions focus on changing diet and physical activity.8 However, we 
have demonstrated the importance of addressing psychosocial determinants of health in the treatment of 
childhood obesity, especially to decrease attrition from treatment.3,11 Each component of MICCO is aligned with 
this goal. MICCO provides targeted psychosocial services to families in partnership with community 
organizations; visits with obesity specialists including a psychologist to assist families with behavior change, 
parenting, mood, and self-esteem; and psychoeducational tools to educate, engage, and empower families.   
B.2 Our study differentiates itself in the design and testing of a mobile application that is state-of-the-
art, user-friendly, and integrated with the healthcare system.41 Nearly all families of children with obesity 
(95%) in our prior studies reported access to the internet through a mobile device, making it an accessible and 
convenient platform to augment healthcare delivery. Other studies have utilized mobile apps for childhood 
obesity,41 but few have been integrated with the healthcare system. Our project leverages the family-friendly 
Figure 3. MICCO Intervention Components  

Nemours App and its integration with the Nemours EHR to deliver MICCO, combining components that families 
can use on their own with components that allow families to interact with their healthcare team, enhancing family 
engagement with the intervention.41 Our study will refine MICCO with best-practice methods used in private 
(marketing) and healthcare (e-health) settings to improve the usability of new technologies42-43 and will leverage 
our collaboration with the Nemours App developers to ensure changes are made quickly and that the newest 
technological innovations are employed in the intervention. 
B.3 We will employ best-practice community-engaged research strategies to ensure that MICCO is 
feasible, relevant, and poised to create sustainable change.44-45 While engagement of community 
stakeholders is increasing in childhood obesity studies, fully engaging stakeholders in a meaningful and rigorous 
manner is still uncommon.46 We will engage a diverse group of stakeholders in rural communities in Delaware, 
including families, community organizations, and primary care practices, as partners in all phases of research 
design and execution to enhance alignment of MICCO with community resources and stakeholder values, ensure 
MICCO is family-friendly, and facilitate effective recruitment, retention, and dissemination.  
C. APPROACH 
C1. OVERVIEW: The proposed study will refine and test an evidence-based, multi-component intervention, 
Mobile Integrated Care for Childhood Obesity (MICCO), delivered through a mobile application platform linked 
to the Nemours EHR. We will engage a Council of Community Partners and a Council of Parent Partners and 
use Think Aloud testing to refine MICCO (Aim 1), which will then be tested in a RCT with families of young 
children with obesity from three primary care practices in rural Delaware to examine impact on attrition and child 
weight (Aim 2) and disparities in these outcomes (Aim 3). Overall project goal: Improve the relevance and 
accessibility of obesity interventions for families in underserved rural communities to reduce health disparities. 
C.2 RESEARCH TEAM: Our team is exceptionally well-qualified to conduct this study, with expertise spanning 
all methodological and conceptual aspects of the proposed work (see Biosketches). Thao-Ly Phan, MD, MPH 
(RPL) is the Medical Director of the Nemours Healthy Weight and Wellness Clinic who has been awarded two 
career development grants to address psychosocial factors that impact weight outcomes, leveraging EHR-based 
technology. Her senior mentorship team has diverse and complimentary areas of expertise and connections with 
professional networks that will strengthen Dr. Phan’s research: (1) Anne Kazak, PhD, ABPP, Director of the 
Nemours CHDS and Nemours PI of PEDSnet, has expertise in psychosocial interventions and implementation 
science and has served as Dr. Phan’s primary mentor on multiple projects; (2) Ann Davis, PhD, MPH, Director 
of the Center for Children's Healthy Lifestyles & Nutrition at the University of Kansas Medical Center, has 
expertise in telehealth obesity interventions for rural populations and has collaborated with Dr. Phan through the 
ISPCTN; (3) Ihouma Eneli, MD, MS, Director of the Center for Healthy Weight and Nutrition at Nationwide 
Children's Hospital and Director of the Primary Care Obesity Network in Central Ohio, has expertise in integrating 
obesity treatment into primary care and has collaborated with Dr. Phan on PEDSnet and AAP Institute for Healthy 
Childhood Weight activities; and (4) Allison Karpyn, PhD is the Director of the Center for Research Education 
and Social Policy at the University of Delaware and member of the ACCEL Community Engagement Core, with 
expertise in community-engaged research and improving access to healthy food for underserved communities. 
This project leverages robust resources offered by the IMPACT Core, including mobile app development 
expertise, and extends our collaboration with Nemours primary care practices and caregivers of children with 
obesity in rural Delaware with the assistance of the PROMISE Core (see C.4, Aim 1). 
C.3 MICCO INTERVENTION: Based on our preliminary work and the Clinical-Community Integration 
Framework, we developed a multi-component intervention, Mobile Integrated Care for Childhood Obesity 
(MICCO, Figure 3), that will be accessible by mobile phone or tablet through a custom dashboard on the 
Nemours App. The Nemours App is an existing state of the art mobile application platform that provides 
comprehensive patient services (tools for education, telehealth, appointments, communication with providers, 
and health management); is accessible by mobile device, tablet, or desktop/laptop computer; and is linked to the 
Nemours EHR (EPIC, see detailed description of Nemours App in IMPACT Core).  All MICCO components will 
be available in English and Spanish, and families will receive hands-on instruction on using MICCO. 
Component 1: Integrated Community Care. Upon beginning the MICCO intervention, the social needs 
screener , refined and tested by members of the research team (see A.3), will be sent to caregivers through the 
Nemours App (in English) or a REDCap survey (in Spanish).  REDCap survey results will be entered into the 
EHR by the community health worker.  A positive screen will appear on an EHR dashboard for review by trained 
community health workers who are an integral part of each primary care practice’s patient-centered medical 
home.  The decision to incorporate a community health worker as part of the team was based on Community 

Partner and Healthcare Partner feedback, given the broader scope of the community health worker’s role and 
their demonstrated effectiveness on the RPL’s recent study to increase COVID-19 vaccine uptake among 
underserved populations. EPIC’s care management tool will be used by the community health worker to establish 
a care plan, refer the family to services (e.g. food banks, transportation services, mental health providers) in their 
zipcode recommended by the Council of Community Partners, and track community programs that have been 
accessed.  The community health workers will participate in the Council of Community Partners to incorporate 
resources shared by community and state organizations into the intervention.  Based on feedback from the 
Council of Community Partners, community resources will also include a monthly healthy lifestyle event for 
participants to encourage peer support and family engagement.  Monthly healthy lifestyle events will include a 
physical activity, healthy dinner, and presentation on a healthy lifestyle topic (e.g., cooking class, mindfulness) 
provided at no cost to participants.   
Component 2: Integrated Obesity Care. Families will receive evidence-based weight management treatment 
consistent with Stage 3 AAP Expert Committee Recommendations and United States Preventive Services Task 
Force (USPSTF) guidelines,8,47 tailored to the needs of each family. Treatment will include biweekly telehealth 
or in-person (included based on parent and healthcare stakeholder feedback) visits with members of an existing 
and established transdisciplinary group of obesity specialists (medical provider, psychologist, exercise 
physiologist, dietitian, and community health worker) from the Nemours Healthy Weight and Wellness Clinic, 
with an interpreter available for families whose preferred language is Spanish. Telehealth visits will be delivered 
via the Nemours App and in-person visits will be provided at Nemours Children’s Health, Milford. Care provided 
will include motivational interviewing to establish lifestyle behaviors goals specific to each child’s needs but 
following evidence-based lifestyle recommendations like MyPlate and the Traffic Light 
Diet, cognitive-behavioral strategies such as self-monitoring and stimulus control, positive 
parenting strategies, and management of child mood and self-esteem. Based on feedback 
from parent partners and in recognition of the challenges with attending biweekly visits, 
providers will reach out to parents by their preferred method of communication (App, 
phone, or text) if a family misses a visit.  This outreach will focus on evaluating progress 
with lifestyle behavior goals, problem-solving strategies to assist with lifestyle behavior 
goals, setting new lifestyle behavior goals as appropriate, and ensuring families are 
connected to community programs as needed. 
Component 
3: 
Self-Management 
Tools. 
Families 
will 
be 
provided 
with 
psychoeducational tools in English or Spanish through the Nemours App to promote 
lifestyle behavior change. These will include a self-monitoring tool (Figure 3) to track daily progress toward 
lifestyle behavior goals established during visits, a series of culturally-relevant videos developed by the research 
team to promote positive parenting among families of children with obesity (see A.3, Figure 4), and media-based 
educational resources (e.g., exercise/ cooking videos) to promote healthy lifestyle behaviors curated by 
multidisciplinary obesity specialists. Obesity specialists and community health workers will review data on an 
EHR dashboard about lifestyle behavior goal metrics and anthropometric measurements to inform clinical 
decisions during visits with families.  Participants will also have the option of accessing the YMCA of Delaware’s 
virtual platform through the App at no cost to participants. 
Figure 4. Positive Parenting Videos 
 
 
families will receive compensation for study visits, as detailed on the form. 
 
 
 
 
“The parent is what gets your child 
to come outside. Your child listens 
to you and your child looks up to 
you.” 
“Constant motivation and 
complimenting the child will 
encourage them to keep playing and 
having more fun when they play.” 
“If you come outside with your kid, 
they’re going to feel loved, they’re 
going to feel important, like you have 
an interest in their life.” 
Figure 3. Goal 
Tracking
C.4 STUDY DESIGN: See 
PHS Human Subjects & 
Clinical Trials form for de-
tailed eligibility criteria, 
sample size justification, 
recruitment/retention plan, 
time-line, human subjects 
protection, and data/safety 
monitoring. All participating 

AIM 1. REFINE MICCO WITH COMMUNITY ENGAGEMENT AND THINK ALOUD TESTING 
 
COMMUNITY ENGAGEMENT 
Three communities in Southern Delaware (Milford, Millsboro, and Seaford), each 2+ 
hours from the NCH-D. will be engaged in the study in collaboration with our PROMISE 
Core. The Nemours primary care clinics in these three towns have a diverse patient 
population (Figure 5). Based on EHR data, of the 532 children with obesity ages 4-12 
years living in a rural area who had visited one of the primary care clinics in the past 
year, less than 20% were referred to and less than 10% attended the hospital-based 
obesity clinic, with children of Hispanic ethnicity being even less likely to be referred, 
underscoring disparities in accessing care.  A Council of Community Partners and 
Parent Partners will serve as active members of the research team. Partners will 
participate in monthly calls and frequent e-mail correspondence, receiving a stipend for 
their time. The Councils will provide insight into implementing the study in and 
disseminating findings to the community, with each partner informing aspects unique to 
their perspective. There will be three members from each of 3 groups: 
1) PCPs will inform integration of MICCO and standard of care into the patient-centered 
medical home; 
2) Primary care coordinators will determine best approach for care coordination of psychosocial services; 
3) Community organizations providing social services or community centers will identify and facilitate 
access to relevant community-based psychosocial services and lifestyle resources to address family 
psychosocial needs, will help recruit families from their organizations through advertisement and inform best 
ways to recruit and engage families during the course of the study .  
Six families of children with obesity of diverse backgrounds will serve on a Council of Parent Partners and 
inform ways to increase the relevance of MICCO content and decrease the burden of participating for families. 
 
THINK ALOUD TESTING: Families of children ages 4-12 years with obesity who receive care from the primary 
care clinics will be recruited using purposeful sampling. Families who meet eligibility criteria will be identified 
from a report generated from the electronic health record.  Legal guardians will receive an initial recruitment text 
to the preferred mobile number identified in the electronic health record.  Research staff will contact legal 
guardians who express interest to screen for eligibility and review the consent form, if eligible. Legal guardians 
will provide feedback on the usability of the MICCO mobile application via Think Aloud testing, an evidence-
based method for obtaining in-vivo feedback that has been used by members of the IMPACT Core in the 
development of e-health interventions.42-43 Legal guardians will meet with a trained research team member via a 
secure online meeting platform, which will allow them to experience the app with their own internet connection 
and mobile or computer device. Participants will be asked to remain off camera and to sign onto the meeting 
with their study ID number to maintain confidentiality.  If potential participants prefer to conduct the session in-
person, an in-person session can be arranged with a preference for participants to still use their own device to 
experience the app.   After a brief introduction to MICCO, families will be instructed on how to access the MICCO 
App prototype on their mobile device, tablet, or computer. They will then be instructed to use MICCO and 
encouraged to say everything that they are thinking and doing as they navigate independently through the 
components, sharing their screen so that the research team member can view their screen flow. There will also 
be a brief series of qualitative interview questions to assess for acceptability of the App (please see attached 
interview guide). The research team member will record the session (audio and screen share if conducted online, 
audio if conducted in-person) and take notes on observations, including feedback about content and technology. 
The recording will be transcribed by a professional transcription company.  Personal information will be deleted 
from the transcript and the recording will be deleted after the study is complete. After each session (30-60minutes 
in length), family feedback will be summarized utilizing a modified cognitive interview analysis protocol.48 The 
process will be iterative, with real-time changes made quickly after each session, expedited by our collaboration 
with the Nemours App developers, and testing ending when saturation is achieved (i.e., no novel suggestions 
for improvement identified). It is anticipated that 5-10 families will be needed to achieve saturation of responses.42 
 
 
Figure 5.  Primary care clinics in 
Southern DE 

AIMS 2 and 3: EXAMINE IMPACT OF MICCO ON FAMILY ENGAGEMENT AND CHILD ADIPOSITY AND 
DISPARITIES IN THESE OUTCOMES 
PARTICIPANTS: 184 families of children with 
obesity (BMI percentile ≥ 95th percentile for age) 
ages 4-12 years who are patients of the primary 
care practices in Milford, Seaford, or Millsboro 
serving primarily rural populations will be 
identified from the EHR and with advertisement 
at community centers. Participants identified 
from the EHR will be contacted by text and/or e-
mail message.   Interested participants will be 
advised to contact a research team member, 
who will then contact interested families to 
assess eligibility criteria and interest in 
participation.  If a family is eligible and 
interested after this contact, the research team 
member will arrange a time to conduct an 
informed consent process with the participant, 
who will sign an electronic consent.  
STUDY DESIGN: Enrolled families will be randomly allocated to receive MICCO (see C.3) or an active control 
condition (standard care) using a 1:1 randomization scheme stratified by race/ethnicity (three groups impacted 
most by obesity in the community: Latino, non-Hispanic Black, non-Hispanic White; Figure 6). The intervention 
will be delivered over 6 months. 
STANDARD CARE: An active control condition was selected to demonstrate the impact of the intervention 
beyond the typical care that a child would receive in primary care. Standard care will include bimonthly in-person 
visits for lifestyle counseling with the child’s PCP per 2023 AAP Clinical Practice Guidelines.47  PCPs will receive 
training on these recommendations at the start of the clinical trial, with refresher training provided every six 
months and a lifestyle handout provided to facilitate education at each nursing visit. PCPs will not be trained on 
MICCO. Only participants in the MICCO group will have access to the MICCO dashboard on the Nemours App 
to prevent contamination. 
OUTCOME MEASURES 
Family Engagement in Treatment: Study visits will be documented in the EHR as part of routine clinical care 
for all patients, including the number of visits with primary care providers (where obesity and lifestyle counseling 
was provided, per ICD-10 codes) or obesity specialists (including type of specialist) and number of 
cancelled/missed visits. Attrition (non-attendance to 6 month follow-up visit) will be assessed via EHR review.  
In addition, number of days in study will be assessed as a secondary outcome. 
Child Adiposity: Weight will be measured with a wireless smart scale that has been used in prior research and 
demonstrated excellent agreement with research-grade scales.49-50 Height will be measured using a reliable 
method used by RPL Phan and mentor Davis using a measuring tape and ruler, which has demonstrated validity 
when compared to measurement of height with a medical-grade stadiometer measured by a research team 
(Forset, et al., 2022).51 Procedures for ensuring reliability of measurements using these devices will be followed, 
per guidelines established by Krukowski and Ross during the pandemic.50 Children will be measured by their 
caregiver each month in advance of visits, with weight measurements transmitted wirelessly to and height 
measurements entered into the Nemours App for the MICCO Group and measurements entered into the EHR 
by research staff for the Standard Care group.  
Disparities: Child race/ethnicity and insurance (proxy measure of socioeconomic status) will be collected from 
the EHR. Age, sex, caregiver preferred language, and social needs (from screener) will also be collected. 
C5. DATA ANALYTIC PLAN.  Think Aloud Testing (Aim 1): Themes from qualitative interviews will be 
identified using an inductive thematic approach (see PHS Human Subjects Form for more detail).53 RCT (Aim 
2): Based on prior research describing the impact of behavioral interventions on BMI z-scores, we expect a mean 
difference in adjusted BMI z-score of 0.25 with the intervention, an effect size that has also been associated with 
a change in cardiometabolic risk.8 A sample size of 92 participants (46 in each group) can detect an effect size 
of this magnitude with a power of 80% and a level of significance of 0.05, assuming a 50% attrition rate based 
Measures (N = 46) 
Weight and height for every visit 
Visit adherence and attrition 
Figure 6.   
RCT 
Design 
Measures (N = 46) 
Weight and height at every clinic visit 
Clinic visit adherence and attrition 
MICCO (6 months) 
Care coordination through App 
Biweekly visits  
Self-management tools in App 
MICCO Group (N = 92) 
Equal distribution of Black, Latino, White 
Families of children 4-12 yo with obesity 
Recruited from EHR report and from community 
Standard Care Group (N = 92) 
Equal distribution of Black, Latino, White 
Conservative 
Lost to Follow-Up 
(N = 46)
Standard Care (6 months) 
Bimonthly in-person lifestyle counseling 
with PCP per Stage 2 AAP Expert 
Committee Recommendations 
Conservative Lost 
to Follow-Up  
(N = 46) 

on prior studies,11-12 we would need to enroll 184 participants (92 in each group). A mixed effects model with 
random coefficients will be used to assess the longitudinal effects of MICCO on changes in adjusted BMI z-score 
to minimize the effect of missing data. Logistic regression analysis will be used to assess the effect of the 
intervention on attrition. Disparities (Aim 3): The same models will be used to preliminarily assess the interaction 
between the intervention and race/ethnicity and insurance on adjusted BMI z-score and attrition to inform a larger 
multi-site trial that will be fully powered to evaluate disparities. Due to pilot nature of study and variability in 
engagement, the decision was made by the COBRE External Advisory Committee to end enrollment after 1 year. 
C.6 POTENTIAL PROBLEMS, ALTERNATIVES. Analysis of EHR data suggests that it will be feasible to recruit 
the sample size intended and advertisement of the study through our community partners will also facilitate 
recruitment. However, if recruitment is slow we may expand eligibility to include children with BMI ≥ 85% or from 
other Nemours clinics in rural areas. Every effort will be taken to refine MICCO based on input from stakeholders; 
if MICCO is found to be ineffective in the RCT, we will obtain qualitative feedback from our Councils, analyze 
app analytics, and assess whether behavior change improved. We understand that technology evolves quickly 
and modifications may be needed to ensure that the intervention remains current. We will leverage Nemours’ 
investment in innovative technologies and the expertise of our IMPACT Core to continuously improve our 
intervention to be state of the art.54 If families are experiencing connectivity issues, we may use primary care 
space and equipment for telehealth visits. Finally, success depends on effective collaboration with the community 
and therefore we will incorporate metrics to objectively measure collaborative efforts.27 
C.7 SCIENTIFIC RIGOR. This study was designed to ensure that it will yield robust, unbiased results. MICCO 
incorporates evidence-based strategies for the treatment of childhood obesity that align with USPSTF and AAP 
guidelines and are informed by the team’s preliminary work. Best practice community-engaged research 
methods and usability testing will be used to tailor and refine the intervention for families of children with obesity 
in rural communities of Delaware. A RCT will be used to evaluate efficacy of the intervention, with planned 
sample size calculated to detect a reduction in adjusted BMI z-score that would yield positive cardiometabolic 
outcomes based on prior research and accounting for attrition rates based on prior studies. Stratified 
randomization will be used to ensure a diverse and representative sample from which disparities can be 
preliminarily evaluated. Our study will focus on objective outcome measures to assess intervention efficacy, 
using innovative and automated technology. We will collect additional information about use of MICCO and 
components of standard care visits to account for potential variability in participant experience of either 
intervention. Finally, rigorous data analytic approaches and transparent reporting guidelines will be followed. 
C.8 FUTURE DIRECTIONS. This study will position Dr. Phan to secure external funding to conduct a large-
scale, multi-site implementation trial of MICCO, for example through existing collaborations with the ISPCTN or 
PEDSnet, leveraging common EPIC interfaces among sites. With a refined intervention and robust data from a 
single site RCT, Dr. Phan will be highly competitive to apply for funding from the NIH (NICHD/NIDDK R01) or 
funding from PCORI in year 2 of the COBRE, with a larger goal of transforming healthcare delivery and policy 
for children with obesity to include integrated preventive care and innovative technologies to expand the reach 
of this care. Importantly, this study will increase capacity for community-engaged research in rural Delaware to 
ensure that research with these populations continues to be conducted in a meaningful and impactful manner.