Family Connections: Cultural Adaptation and Feasibility Testing of a Technology-based Pediatric Weight Management Intervention for Rural Latino Communities
Phase: NA
Conditions: Childhood Obesity
Sponsor: University of Nebraska

 
Title: Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino 
Communities 
 
NCT number: NCT04731506 
 
Document date: March 23, 2023 

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Biomedical
SECTION I
Therapeutic/Non-Therapeutic 
Does your research involve a drug, medical device, technique or other intervention or
strategy (including means like diet, cognitive therapy, behavioral therapy, exercise) to
diagnose, treat or prevent a particular condition or disease: "THERAPEUTIC
RESEARCH"?
Yes
1. Title of Protocol: 
Family Connections: Cultural adaptation and feasibility testing of a technology-based
pediatric weight management intervention for rural Latino communities
2. Responsible Personnel: 
A. Principal Investigator (PI):
Silva, Fabiana B - COPH Health Promotion - 402-559-6363 - fabiana.silva@unmc.edu - alt
#: 402-552-6363 - degree: PhD
B. Secondary Investigator (SI):
Almeida, Fabio - COPH Health Promotion - 402-559-9395 - fabio.almeida@unmc.edu - alt
#: 402-559-9395 - degree: PhD
Eisenhauer, Christine Marie - CON-Northern Division - 402-844-7897 -
ceisenhauer@unmc.edu - alt #: 402-844-7897 - degree: PhD, APRN-CNS
Estabrooks, Paul A - COPH Health Promotion - 402-552-6837 - paul.estabrooks@unmc.edu
- alt #: 720-261-7587 - degree: PhD
Kachman, Steve Daniel - Statistics - 4024727302 - steve.kachman@unl.edu - alt #:
402-472-7302 - degree: PhD
Michaud, Tzeyu L - COPH Health Promotion - 402-559-9664 - tzeyu.michaud@unmc.edu -
alt #: 402-836-9195 - degree: PhD - address: MCPH 2047 UNMC Midtown (Zip 4365) -
phone: 402-836-9195
C. Participating Personnel:
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Ferreira Marta, Felipe E - COPH Health Promotion - 402-559-4325 -
fferreiramarta@unmc.edu - alt #: 402-552-6363 - degree: PhD
Ochoa-Rojas, Daisy - COPH Health Promotion - 402-559-4325 - dochoarojas@unmc.edu -
alt #: 402-552-6363 - degree: BS - address: ECI 2011 UNMC Midtown (Zip 6811) - phone:
9-2908
Rossi Squarcini, Camila F - COPH Health Promotion - 402-559-4325 -
crossisquarcini@unmc.edu - alt #: 402-552-6363 - degree: PhD
Santos, Natalia B - COPH Health Promotion - 402-559-4325 - nsantos@unmc.edu - alt #:
402-305-5315 - degree: MPH - address: MCPH 2028 (Zip 4365) - phone: 402-559-4325
D. Lead Coordinator:
Favero Alves, Thais - COPH Health Promotion - 402-559-4325 - thais.alves@unmc.edu - alt
#: 402-559-4325 - degree: MS - address: MCPH 1019 UNMC Midtown (Zip 4350) - phone:
9-4325
E. Coordinator(s):
F. Data/Administrative Personnel:
G. Are you a student or house officer?
No
3. Funding Source: 
Check all that apply and provide the source of the funding.
Cooperative Group: 
Center for Clinical and Translational Research (CCTR) 
♦ Federal (e.g., NIH) Grant - Provide source:  Sub-award - Research Project - PAR-16-241:
Limited Competition: Renewal of Centers of Biomedical Research Excellence
(COBRE)(P20)
Other Grant: 
Departmental funding 
Commercial - Provide company name: 
Department of Defense 
Other - Provide source (e.g. personal funding): 
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4. Deadline for IRB Approval: 
♦ Yes - Explain and provide date:  NIH Funding release is pending on IRB approval - 30
days after submission (aprox. Nov 1st, 2020)
No 
5. Contract: 
Is there a contract associated with this study?
No
6. Agreements 
Is there a Material Transfer Agreement (MTA) associated with this study?
No
Is there a Data Use Agreement (DUA) associated with this study?
No
Is there a Data Transfer Agreement (DTA) associated with this study?
No
7. Study Sites: 
A. Provide the names and locations of all study sites where this research will be
conducted under the oversight of the UNMC IRB or Joint Pediatric IRB.
Central District Health Department (CDHD),
Community Action Partnership of Western Nebraska (CAPWN),
East Central District Health Department (ECDHD),
Two Rivers Public Health Department (TRPHD)
B. Will the research be conducted at external sites under the oversight of an external
IRB?
No
C. Does UNMC, TNMC, CHMC or UNO serve as the lead site with responsibility for data
and/or safety monitoring?
Yes
List the sites.
UNMC
Central District Health Department (CDHD),
Community Action Partnership of Western Nebraska (CAPWN),
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East Central District Health Department (ECDHD),
Two Rivers Public Health Department (TRPHD)
UNL
D. Does this study involve any international sites where the PI will either; 1) conduct 2)
supervise or 3) receive / ship HBM or data to / from UNMC?
No
E. Does this study involve face to face contact with subjects?
Yes
8. Principal Investigator Assurance
The PI understands and accepts the following obligations to protect the rights
and welfare of research subjects in this study: 
I certify that:
I have carefully reviewed this application and all supporting documents. I have
determined that the application is accurate, complete and ready for submission
to the IRB.
I, and all listed research personnel, have the necessary qualifications, expertise,
and hospital credentials to conduct this study in a manner which fully protects
the rights and welfare of research subjects.
There are, or will be, adequate resources and facilities to safely initiate, carry
out and complete this research at the study sites specified in Section I.7. This
includes sufficient staff, funding, space, record keeping capability, and
resources necessary to address adverse events and any unanticipated
problems involving risk to the subject or others. If the necessary resources
become unavailable I will promptly notify the IRB.
All listed research personnel, including external investigators, will be given a
copy of the final IRB approved application and any other relevant study-related
documents in accordance with their defined responsibilities.
All listed research personnel, including external investigators, will be notified
promptly of any changes in protocol, in accordance with their defined
responsibilities.
Research personnel, including data and administrative personnel who have
access to protected health information (PHI) or subject identifiers will have
adequate training in confidentiality and protection of PHI.
The minimum amount of protected health information (PHI) or other identifiers
necessary will be used and disclosed to conduct this research study (if
applicable). I will implement reasonable safeguards to protect the PHI/identifiers
at all times.
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I and all other personnel listed in Section I.3A-E of the IRB Application have
disclosed all potential financial conflicts of interest as required and are in full
compliance with the UNMC Conflict of Interest Policy #8010 and HRPP Policy. I
further certify that all potential financial conflicts of interest are appropriately
managed in order to ensure protection of the rights and welfare of subjects.
I recognize that:
As the PI it is my responsibility to ensure that this research and the actions of
all research personnel involved in conducting the study will comply fully with
the IRB-approved protocol (including all amendments), all applicable federal
regulations, state laws, and HRPP policies.
It is my responsibility to ensure that valid informed consent/assent will be
obtained, as appropriate, from all research subjects or their legally authorized
representative(LARs).
I will:
Ensure that all research personnel involved in the process of consent/assent
are properly trained and are fully aware of their responsibilities relative to the
obtainment of informed consent/assent according to federal regulations, state
laws, and HRPP policies.
Promptly inform the IRB of internal adverse events, as well as any unanticipated
problems involving risk to the subjects or to others, as required within the time
frame defined by HRPP policies. I will analyze each internal adverse
event/reported problem to determine if it impacts the risk-benefit relationship of
the study, the safety of the subjects, or informed consent.
Analyze each MedWatch/safety report to determine if it impacts the risk/benefit
relationship of the study, the safety of the subjects, or informed consent.
Promptly submit external adverse event reports in accordance with HRPP
policies.
Promptly inform the IRB if I become aware of 1) any complaints from research
subjects, LARs, or others about research participation, 2) violations of federal
regulations or state law, 3) violations of the HIPAA Rule, or 4) violations of
HRPP policies.
Promptly inform the IRB of the results of external audits performed by
sponsors, Contract Review Organizations (CROs), cooperative groups, FDA, or
other external groups.
Not initiate any change in protocol without IRB approval except when it is
necessary to reduce or eliminate a risk to the subject, in which case the IRB will
be notified as soon as possible.
Promptly inform the IRB of any significant negative change in the risk/benefit
relationship of the research as originally presented in the protocol and
approved by the IRB.
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Maintain all required research records on file and I recognize that
representatives from the IRB, OHRP, HHS, FDA, and other Federal Departments
or Agencies may inspect these records in accordance with granted authority.
I understand that:
Continuing review by the IRB is required at least annually, or as per Federal
Regulations and HRPP Policy, in order to maintain approval status. I will
maintain IRB approval as long as this study is active.
I am responsible for appropriate research billing in accordance with UNMC
Clinical Trial Professional and Technical Fee Billing Policy #8008 or applicable
Children's Hospital & Medical Center policy.
Failure to comply with the Common Rule, applicable Subparts B, C, and D of HHS
regulations at 45 CFR 46, applicable FDA regulations, the HIPAA Rule, applicable state
law, HRPP policies, and the provisions of the IRB-approved protocol may result in
suspension or termination of IRB Approval of my research project and/or other
administrative or legal actions.
Silva, Fabiana B - 2022-05-04 12:37:11.357
9. Principal Investigator Financial Interest Disclosure 
A. As the PI, I declare:
♦ I have no financial interest in this research.
I have a financial interest in this research. 
B. As the PI, I understand
♦ I must disclose any change in my financial interest during the course of this research
within five (5) business days from the time the change becomes known.
C. As the PI, I certify that:
♦ No Responsible Personnel have a financial interest in this research.
The Responsible Personnel listed below have informed me that they have a financial
interest in this research. 
D. I have informed all Responsible Personnel that if there is any change in their
financial interests during the course of this study it must be disclosed within five (5)
business days from the time the change becomes known.
Silva, Fabiana B - 2022-05-04 12:37:11.357
11. Scientific/Scholarly Merit and Resource Review Certification 
Scientific Reviewer:
Tibbits, Melissa K - COPH Health Promotion - 402-559-9447 - mtibbits@unmc.edu - alt #:
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402-559-9447 - degree: PhD - address: Does not work on campus MCPH 1016 UNMC
Midtown (Zip 4365)
As the Scientific Reviewer,
♦ I do not have a financial conflict of interest associated with this study.
I do have a financial conflict of interest associated with this study. 
My signature certifies that:
this application has been reviewed for scientific/scholarly merit and available
resources. It has been determined that the application merits consideration by
the IRB based upon the following:
The proposal has an acceptable level of scientific/scholarly merit which justifies
the involvement of human subjects.
The proposal has a sound research design in consideration of the stated
objectives,
The PI has the necessary qualifications, experience and credentials to conduct
this research.
The PI has or will have the necessary funding to support this research
There is or will be adequate physical space required for the research
interventions at all study sites specified in Section I.7. In addition, there is or will
be adequate laboratory and administrative support, data storage capability, and
any other resources necessary to complete this research.
At all study sites specified in Section I.7, there is or will be emergency
equipment, personnel, or services necessary to respond promptly to adverse
events or unanticipated problems involving risk to the subject or others.
I will promptly notify the IRB if the necessary resources to support this research
become unavailable.
Tibbits, Melissa K - 2020-10-14 10:17:00.000
Do you have any additional comments that you wish the IRB to consider during the
review of this application?
No
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SECTION II
PROTOCOL ABSTRACT
1. Provide a brief (less than 2500 characters) abstract of the research protocol.
(2500 characters)
This summary should include: 1)) a brief description of the purpose of the study, 2)
eligibility criteria, 3) interventions and evaluations and 4) follow-up.
The purpose of this study is to conduct a mixed-methods study to determine the feasibility of
delivering a culturally appropriate Family-Based Childhood obesity program (FBCO) via an
automated telephone system (IVR) and two in-person group sessions to Latino/Hispanic
(L/H) families (parents and children dyads) living in rural Nebraska will be invited to
participate in focus groups and technology-usability tests (Aim 1) or randomized to a
standard-care control group or an IVR/video delivered intervention (Aim 2). The proposed
study will involve approximately 266 (Aim 1=35, Aim 2=116) L/Hs participants. The parent-
child dyads (n=116) include adults (19 years of age or older, n= 58) and their children (6-12
years of age, n=58) living in rural Nebraska over a period of 12 months and 2 different
stages of the project. In addition, we will involve 40 adults-parents from L/H families from the
sampling region to participate in two rounds of focus groups (FG, n=80) with 6 parents
taking part in usability tests (UT, n=6), and approximately 10 adults to participate in a
Community Working Group (CWG, n=10) that will participate in two interviews (n=10) and
advise in the study and assist in intervention adaptation, recruitment and retention. In Aim 1,
we will adapt all intervention materials to better fit the rural L/H community profile, including
translation of materials to Spanish, inclusion of culturally relevant content and images, and
use of health communication strategies to address different levels of health literacy. Then,
we will evaluate the acceptability, suitability, and usability of the adapted intervention
materials and mode of delivery. In Aim 2, we will randomly assign family participants to
either FC (n=29) or an enhanced standard-care (SC) group (n=29) and determine overall
study reach, preliminary effectiveness in reducing child BMI z-scores, potential for program
adoption, implementation, and sustainability through local health departments (RE-AIM
outcomes). We will also evaluate health department perceptions of i-PARIHS constructs
(Innovation, context,recipient characteristics), and FC participants view of the intervention
(i.e. relative advantage, observability, trialability,complexity, compatibility).
PURPOSE OF THE STUDY AND BACKGROUND
2. Purpose of the Study 
What are the specific scientific objectives of the research?
Our primary specific aims are:
Aim 1: To culturally adapt and determine the relevance, acceptability, and usability of
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a culturally adapted technology-delivered FBCO intervention for L/H families in rural
Nebraska. Applying an iterative collaborative process, we will use a mixed-methods
approach to culturally adapt FC to better fit the rural L/H community profile. A Community
Workgroup facilitated by our rural partner organizations in Nebraska with a high population
of L/H residents and theory-and data-driven approach using structured community input
adaptation process will be conducted to develop and evaluate the relevance (ecological
validity and equivalence), acceptability, and usability of all the adaptations made. We
hypothesize that this process will lead to a program that is relevant, acceptable, and usable
by L/H families in rural communities.
Aim 2: To evaluate the feasibility and preliminary effectiveness of a technology-
delivered FBCO intervention for L/H families in rural Nebraska using RE-AIM and i-
PARIHS. We will randomly assign participants to either FC (n=29) or an enhanced standard-
care (SC) group (n=29) and determine overall study reach, preliminary effectiveness in
reducing child BMI z-scores, potential for program adoption, implementation, and
sustainability through local health departments (RE-AIM outcomes). SC participants will
receive a workbook. FC participants will receive a workbook, 2 in person group sessions
followed by 10 IVR calls over a period of 6 months. We hypothesize that a culturally adapted
FC program will lead to a higher engagement (reach, retention and completion), significant
higher proportion of L/H children reducing their BMIz scores at 6 months when compared to
SC group, align (social validity) with health department perceptions of i-PARIHS constructs
(Innovation, context, recipient characteristics), and that FC participants will view the
intervention positively (i.e. relative advantage, observability, trialability, complexity,
compatibility).
3. Background and Rationale 
Describe the background of the study. Include a critical evaluation of existing
knowledge, and specifically identify the information gaps that the project is intended to
fill.
The burden of childhood obesity (CO) on L/Hs and rural communities. There are
marked ethnic and rural-urban disparities in the prevalence of childhood obesity1,2. The
prevalence of CO among L/H children is almost 60% higher than that of non-L/H Whites1,
and among children in rural areas is estimated to be 25%3 to almost double4 that of urban
areas. Between 2000 and 2010 the number of L/H individuals in rural Nebraska counties
increased by 63.3% and by 2050 Latinos are expected to represent 51.2% of rural
Nebraskas population5. Effective Family-based childhood obesity interventions low
reach and engagement among L/Hs. Identifying effective interventions to reduce health
disparities and to address childhood obesity remains a top public health priority6. Previous
findings reveal that culturally-adapted interventions appear to be more efficacious in the
reduction of obesity in minority children7-9. A number of recent reviews10-13 have shown that
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family-based lifestyle interventions can lead to modest improvements in child BMI. In fact,
the American Academy of Pediatrics, has issued its strongest recommendation grade
(grade A) for Family-based childhood obesity (FBCO) interventions with parents as a focus
for behavior modification for the management and treatment of obesity in children ages 6 to
1114. However, these interventions have been poorly accessed in L/Hs and other minority
populations12,13. Nevertheless, a number of culturally tailored interventions for CO
prevention and management among L/Hs have been tested3,11. These interventions have
primarily included in-person face-to-face group-based delivery of content by a peer educator
(community health worker - CHW) or health professionals (physicians and nurses) in a
variety of urban community locations3. While these adaptations have led to modest BMI
reductions, poor study designs, high attrition rates, small sample sizes and lack of
representativeness (minorities and rural underrepresentation), diminish the potential impact
of these interventions11-13.
The potential of interactive technology to address barriers to reach and engagement
among rural L/H families. The low rates at which evidence-based interventions are
delivered suggests that simply recommending programs based in their availability and
effectiveness, while necessary, is not sufficient given the myriad of barriers at the client,
providers, team, and organizational-levels15. A lack of responsiveness to cultural needs and
preferences negatively affects reach, adoption, implementation, suitability, and scale-up of
interventions in community settings16. Interactive technologies may provide a possible
solution to these challenges in that it offers an avenue for the delivery of FBCO relevant
content at times and places convenient to families17,18. A meta-analysis showed that
culturally-adapted interventions that promote lifestyle changes including parental
involvement and the use of interactive technologies are the most promising in the reduction
of obesity in minority children19. Our own work has demonstrated that technology-assisted
FBCO interventions can lead to significant child BMI reduction using an interactive voice
response (IVR) system to deliver the majority of the intervention content20. Additionally, L/Hs
tend to make more use of mobile devices for both telephone usage and accessing the
Internet than non-L/Hs21. A recent study with L/Hs living in rural and urban Nebraska found
that over 82% of L/Hs have mobile devices and use it regularly to access information22.
They have also indicated preference for receiving health information through verbal
communication methods22. Thus, telephone systems that provide automated (i.e., IVR
system) health education messages combined with in-person face to face strategies may be
practical methods for providing culturally appropriate nutrition, physical activity, and weight
loss information and engaging L/H families in rural communities. IVR has been used in a
number of healthcare contexts to address a variety of health outcomes20,23,24. IVR has also
been found to be acceptable and helpful25, with over 76% of our participants perceiving the
IVR system easy to use, 75% agreeing that IVR messages could help them lose weight26,
and nearly 80% indicating it should be included as part of standard care20. Previous IVR
research has been conducted using rigorous RCT trial methodology in the areas of diabetes
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prevention27, diabetes self-management28, dietary outcomes29, and childhood obesity
treatment20,30. However, there are no published reports on culturally adapted FBCO
interventions that are delivered primarily via IVR that reach a large and representative
sample of L/H families in rural communities.
Summary of significance and literature gaps. The proposed application is timely and
important because: (1) effective FBCO interventions exist, yet they fail to attract and engage
a representative sample of L/H families; (2) there is no evidence that these programs can be
implemented and sustained in rural communities; (3) rural health departments and clinical
settings lack the resources to deliver existing FBCO; and (4) IVR shows promise in
addressing barriers and builds on L/Hs preferences. The scientific premise of this
application is that the use of IVR to deliver culturally appropriate FBCO programing adapted
through a community-driven approach will allow us to address existing rural family and
setting-level barriers while capitalizing on the preferences of the intended audience.
Conceptual Framework. The theoretical basis for our study is the 31revised Promoting
Action on Research Implementation in Health Services (i-PARIHS) Framework32 combined
with the RE-AIM framework33 (Figure 1). The implementation of effective programs can be
viewed as a function of the characteristics of the proposed innovation, the target population
(beneficiaries-our addition to i-PARIHS), delivery agents (recipients), the delivery
context, and facilitation resources32. Our innovation is the cultural adaptation and
customization of the materials from the Family Connections (FC) program20.
Contextually, our community partners (CP; see letters of support) will be members of the
community workgroup (CWG) and will play a central role throughout the process to improve
the social validity31,34 and feasibility of the innovation while considering factors such as
leadership, experience with adopting and implementing interventions, and organizational
context and cultural relevance. Facilitation of the innovation within the practice context
will be guided by the research team using a consultee-centered training approach35 as we
have in the past36. We will use automated implementation of intervention content to ensure
high fidelity (IVR calls) and keep implementation complexity low to address delivery system
barriers (i.e. lack of resources, knowledge and training)37 and L/H families participation
barriers (i.e. lack of public transportation and cultural relevance, family and work
responsibilities)37, while targeting preferences for information receipt (i.e. verbal and
written22). RE-AIM33 will provide guidance on the outcomes (Figures 1 and 3) to ensure our
innovation addresses issues of scalability at the individual and organizational level as well
as the resources, infrastructure, and flexibility necessary for future implementation. Finally,
cultural adaptation is an important part of the implementation process16. As such, we will
make adaptations guided by a theory-driven approach that is both selective (focuses on
areas with poor fit among L/Hs in rural communities) and directed (aimed at improving
engagement and outcomes)31,38. We hypothesize that by incorporating community-informed
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design features that tend to the cultural needs of L/H families, it will promote engagement
and better outcomes independent of parents acculturation level.
INNOVATION
This proposal represents a conceptual and methodological innovation in the FBCO
intervention translation field. First, using both implementation science and cultural
adaptation models we seek to understand factors that are related to those who would
benefit from engaging in the intervention (beneficiaries) and those who would ultimately
deliver the intervention39 by adapting and testing the initial cultural relevance and
effectiveness of a technology-delivered FBCO program concurrently with understanding the
potential impact of our adaptations. The key thesis is that by understanding the underlying
types and reasons for our adaptations we can improve the fit (ecological validity31,40,41)
between the intervention and context to improve future engagement31,42 and
implementation43. Second, we propose to address multiple cultural sensitivity dimensions7,
including surface modifications (translation) to increase feasibility, and deep modifications
(methods and content) to enhance impact44. Third, delivering FBCO programs through
interactive technology is feasible20, however, there is no evidence that these approaches
can attract and keep engaged a representative sample of L/H families13. We will be the first
to use IVR as part of a culturally adapted FBCO program for L/H families in rural areas. This
is a significant departure from previous cultural adaptations of childhood obesity prevention
and treatment trials that have relied primarily on multiple and frequent individual or small
group sessions with mostly urban dwellers, delivered primarily by health professionals and
CHWs13. While FC has used IVR technology, it was not specifically developed and adapted
for L/H families in rural communities. Fourth, retention issues are more prevalent when
interventions move from efficacy to effectiveness studies45, and most FBCO programs12
(including cultural adaptations13) developed and tested to date are restricted by their ability
to geographically reach participants. For the existing technology-based FBCO programs,
none has been able to show statistically significant reductions in child BMI nor attract or
keep engaged a representative sample of L/H families46.In contrast to other adaptation
models40,47,48, the identification of areas for enhancement in the proposed framework31
occurs from the local context and experience of beneficiaries and recipients. Geographic
and culturally relevant barriers are particularly more pronounced for L/H families in rural
communities37. Our intervention has the potential to bridge these gaps by allowing L/H
families to participate in a culturally relevant FBCO program at a location and time
that is convenient to them.
CHARACTERISTICS OF THE SUBJECT POPULATION
4. Accrual 
A. Is this study conducted solely at sites under the oversight of the UNMC IRB (e.g.
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UNMC, Nebraska Medicine, CHMC, UNO)?
Yes
1. How many subjects will need to be consented (per group, as applicable) in order to
achieve the scientific objectives of the research?
The proposed study will involve approximately 272 (Aim 1=106, Aim 2=166) participants.
Participants are required to complete study aims as described:
Aim 1:
We will involve 40 adults-parents from L/H families from the sampling region to participate in
two rounds of focus groups (FG, n=80) with 6 parents taking part in usability tests (UT, n=6),
and approximately 10 adults to participate in a Community Working Group (CWG, n=10)
that will participate in two interviews (n=10).
Aim 2:
The parent-child dyads (n=116) include adults (19 years of age or older, n= 58) and their
children (6-12 years of age, n=58) living in rural Nebraska over a period of 12 months and 2
different stages of the project randomized in two arms:
Standart Care= 29 dyads (58 participants)
FC intervention= 29 dyads (58 participants)
At the end of the intervention parents participating that participated in the intervention (FG,
n=40) and CWG (n=10) will be invited to participate in focus groups for a post-program
satisfaction and evaluation.
2. What is the statistical or other justification for the total number of subjects described
above?
Aim 1 sample based in the literature recommended number per evaluation for focus group
(5-10 participants) and usability tests (5 per test)74.
Intervention testing sample size is based on the comparison of changes in BMI z-scores
achieved by participants in FC-IVR with those achieved by participants in FC-workbook
condition at 6 months post randomization14. A total of 56 (23 per group) parent-child dyads
achieves 80% power (alpha 0.05) to detect a significant difference between the SC and IVR
conditions, based on the relative BMI z-score differences (0.05) and standard deviation
related to 6-month BMI z-score reduction for FC-IVR (0.06). To account for 25% rate at
12-month, we will recruit a total of 58 (29 per group) dyads.
5. Gender of the Subjects 
A. Are there any enrollment restrictions based on gender?
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No
6. Age Range of Subjects 
A. Will adults be enrolled ?
Yes
1. What is the age range of the adult subjects?
19 years of age or older.
2. What is the rationale for selecting this age range?
This is a prospective study of a family-base childhood obesity (FBCO) intervention program.
Study participants will include both adults (>19 years) and children (6-12 years) living in
rural counties located in the Nebraska, recruited through contacts at the Health
Departments responsible for these counties. Parents/ are often the primary food providers
and caretakers of children living in the home, so their diet selection and physical activity
example often have the greatest impact on the children. Also stakeholders and community
partners are adults that follow in this range.
B. Will children (18 years of age or younger) be included in this research?
Yes
1. What is the justification for inclusion of children in this research?
Overweight children are known to be at-risk for numerous weight-related health conditions
such as diabetes, hypertension, and cardiovascular disease. The intervention are
specifically targeted parents/guardians of overweight children and will be tested among
parents and evaluating their children outcomes. In addition to obtaining written informed
consent from the parents/caregivers, children will also provide assent prior to any study
activities. The proposed protocol in this application is designed to protect the enrolled
children and their personal data.
2. What is the age range for the child subjects, and what is the justification for
selecting this age range?
The evidence-based Family Connection intervention20 upon with this study proposes to
adapt is specifically designed and targeted parents/guardians of overweight children 6-12
years old. Thus, study will include approximately 58 children following the inclusion criteria
in this study: (a) age 6-12 years (b) BMI z-score ³85th percentile (c) self-Identified L/Hs
living in target counties (d) assent to participate in the study.
3. Will this study enroll wards of the state?
No
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7. Race and Ethnicity 
Are there any subject enrollment restrictions based upon race or ethnic origin?
Yes
a) Explain the nature of the restrictions and provide justification.
Latino/Hispanic families are the focus of this study. Based on our research eligibility criteria
that target self-identified Hispanic or Latino participants, we anticipate that 100% of recruited
subjects will be of Hispanic or Latino ethnic minorities, some monolingual in the Spanish
language. Research staff who will conduct recruitment, informed consent, and study
procedures will be required to speak this language fluently; therefore, potential subjects will
not be excluded from research because of their inability to speak English. Conversely, all
staff will be fluent in English so no L/Hs will be excluded from the study due their language
preference. The community health workers and CWG will work with the investigative team to
assist in developing and employing recruitment strategies that have demonstrated
effectiveness for successfully engaging minority L/Hs into previous health programs.
However, community members of Health Departments who are not minorities (e.g. others
races/ethnicity) may participate as CWG members.
8. Vulnerable Subjects 
A. Will prisoners be included in the research?
No
B. Select from the list all of the vulnerable populations that will specifically be recruited
to participate in this research.
Decisionally-impaired persons 
Critically ill patients 
Students of the investigator 
Employees of the investigator 
Educationally disadvantaged individuals 
Socially or economically disadvantaged individuals 
Individuals with a stigmatizing illness or condition 
Individuals from a marginalized social or ethnic group 
Other. 
♦ No vulnerable subjects will be specifically recruited
9. Inclusion Criteria 
What are the specific inclusion criteria?
Intervention Adult Participants
1. Age >=19
2. Self-identified L/Hs living in target counties
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3. Parent of a child aged 6-12 years with a BMI z-score ³85ths
4. Willing and able to give informed consent
Children Participants
1. Age 6-12 years
2. BMI z-score 85th percentile
3. Self-Identified L/Hs living in target counties
4. Assent to participate in the study
Community Working Group (CWG)
1. Rural health department administrators who participated in the preliminary study and
development of the current application. They include our partners at CDHD (Teresa
Anderson), ECDHD (Chuck Sepers), TRPHD (Jeremy Eschilman), and CAPWN (Betsy
Vidlak).
2. Rural health department clinical staff (CHWs, Nurses, Clinicians, n=4) and state health
department representatives (Josie Rodriguez, Nebraska Department of Health and Human
Services [NDHHS]) who participated in the preliminary study and development of the current
application (total n=5).
3. Adult community members (19 years of age or older) from the sampling region whose
knowledge and experience provides insight into the preferences and needs of the local L/Hs
(n=2).
10. Exclusion Criteria 
What are the specific exclusion criteria?
Intervention Participants:
1. No telephone
2. Contraindication to physical activity or weight loss
3. Planning to move in the next 12 months
4. Currently participating in weight loss program
5. Pregnancy or planning to get pregnant in the next 12 months
6. Not willing to be randomized
7. Not willing to consent or assent to participate
Community Working Group - None
11. Pregnancy and Contraception Requirements 
A. Are women of child bearing potential (WOCBP) included in this research?
Yes
a. Are there any specific contraception requirements for subjects?
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No
1. Provide justification for absence of contraception requirements
♦ There are no interventions that are likely to be of risk to a fetus
Investigational drug(s) is (are) not systemically absorbed 
Investigational drug(s) is (are) systemically absorbed, but there is no evidence from human
studies, or from clinical experience, that there is risk to a fetus 
Other 
B. Are pregnant women included in this research?
Yes
C. Are breast feeding women included in this research?
Yes
Provide justification
All women, including child bearing potential (WOCBP), pregnant and breast feeding, can be
a participant as member of the Community working Group (CWG) and in the focus groups.
However we will exclude pregnant and breast feeding women from participating in the
intervention testing. Being pregnant and/or breastfeeding could impact the parent main
outcomes results (weigh loss) of feasibility test with small sample.
METHODS AND PROCEDURES
12. Methods and Procedures Applied to Human Subjects 
A. Are there any evaluations or tests that will be performed for the purpose of
determining subject eligibility which would not be routinely conducted as part of
standard clinical care of the prospective subject?
No
B. Describe the research plan, including all procedures, interventions, evaluations and
tests.
Intervention. Family Connections(FC)20 focuses on parents as an agent of change. It
includes two parent classes, followed by 10 IVR automated telephone support calls over 6
months. This intervention incorporates evidence-based principles83-89 with the goal to
provide parents with the skills and confidence to change the physical and social
environment to be supportive of healthy behaviors. Program materials are provided in a
parent workbook with activities to be completed at home that align with IVR calls to promote
increased physical activity and consumption of fruits and vegetables in concert with
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decreased sugary-drink consumption and screen time. The program starts with 2 small
group support sessions spaced one week apart that guides participants through developing
an action plan for parental behaviors, role modeling, and changes to the home environment
that would facilitate healthy eating and physical activity. It is followed by 10 IVR calls (5-10
minutes) beginning with weekly (4), biweekly (4), and monthly (2) calls. We use the 5As
model90 to help train parents in setting physical activity and healthful eating goals with their
family during our IVR calls. This model includes Assessing behaviors and motivation,
providing Advice on healthy behaviors, collaboratively Agreeing on goals, Assisting parents
with barrier identification and resolution, and Arranging for follow-up90. During each IVR call
parents provide information on current physical activities, and food consumption. This
information is compared to families goals for weight loss, physical activity, and food
consumption and used to provide feedback on success in subsequent IVR calls. Calls also
allow parents to select specific messages related to intervention content and help them
prepare for relapse prevention (Calls 7-10) once the program is completed.
Community Workgroup (CWG) Development and Recruitment. We will convene a group
of community members from organizations serving L/Hs to participate in a CWG91. Drs.
Silva and Eisenhauer will work with our community partners to help identify and invite formal
and informal community leaders to serve on the CWG. The CWG composition will include
10 community members from the sampling region78 whose knowledge and experience
provides insight into the preferences and needs of the local L/Hs.79 CWG participants will be
persons who have influence over their peers (i.e., opinion leaders), yet provide input on real-
world issues and can leverage any necessary changes to minimize barriers to participants
engagement and intervention implementation. Those will include our representatives from
our partners, healthcare providers and L/H community members. Our team will also
participate in the CWG to provide intervention content expertise91. CWG members will meet
quarterly throughout the study and will provide structured qualitative and quantitative
feedback on adaptations, recruitment and engagement strategies of L/Hs families. The
CWG will help develop vertical and horizontal systems relationships and processes needed
to successfully adopt, implement, and sustain the FC program. Topics for CWG meetings
will include strategic development of referral pipelines, strategic recruitment and retention
strategies, and implementation adaptation for local needs. Differences in feedback will be
reconciled via group discussion until consensus is reached. Meetings will also be available
via Zoom video chat technology to CAB members, which is freely
accessible on the internet and feasible to use in low-band width internet locales via
smartphone, PC, tablet, or laptops, to limit access barriers (weather, time) which might
inhibit attendance.
Specific Aim 1: To determine the relevance, suitability and usability of a culturally
adapted technology-delivered FBCO intervention for L/H families in rural Nebraska.
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Figure 2 describes our adaptation approach using a structured community input31,38,41,50. We
propose 4 phases of adaptation based on the Heuristic Framework for Cultural Adaptation 
31. Phase 1: We will conduct a pre-adaptation assessment of the intervention with CWG and
L/H parents to identify intervention characteristics and parents preferences for potential
adaptations. CWG (n=10) will complete the Cultural Relevance Questionnaire (CRQ)41 and
an individual interview, while parents (n=40) will participate in a focus group (FG). Phase 2:
We will conduct surface (language, visuals) and deep (recruitment strategies, setting,
delivery method, foods and recipes) modifications31,38,44. We will use two measures of
readability92,93 and a final series of edits to simplify language to 3rd4th grade level94. Phase
3: We will use a mixed method, task-based usability assessment95 to evaluate IVR Calls &
Workbook. We will recruit 3 to 6 participants with previous studies indicating that 5 may be
the optimal number96. Participants will complete a short questionnaire and receive an
introduction to think-aloud procedure97. A trained bilingual facilitator will lead each session
using a semi structured interview guide, while Dr. Silva observes and take notes.
Participants will be asked to perform standardized tasks, such as engaging with the IVR
system, accessing information on the workbook, or setting a goal. After each attempted
task, we will use open-ended questions to elicit participants (1) expectations for the features
functionality, (2) ability to comprehend the information displayed, (3) ability to navigate to
and from the feature, (4) satisfaction with the feature, and (5) how the feature might be
improved95. To assess satisfaction, parents will complete the adapted Computer System
Usability Questionnaire (CSUQ - ease of use, likability of the interface, and overall
satisfaction). Each session will be video-recorded using QuickTime Player (Apple Inc,
Cupertino, CA) and transcribed. Phase 4: we will conduct a post-adaptation assessment of
using the same procedures and participants from Phase 1 to refine the adaptations. CWG
will make final recommendations for adapted version to be tested under Aim 2. Data
Collection: All participants (CWG and parents) will complete an informed consent prior to
any study-related activity CWG (n=10) will complete structured (i-PARIHS) interviews
(30-minutes) with Drs. Silva and Eisenhauer and the CRQ instrument (web-based) to
provide pre and post feedback on adaptations. The CRQ is a theoretically-based instrument
to evaluate cultural sensitivity (functional, conceptual and linguistic) and ecological validity
(e.g. language and context). It provides information on: (a) language's suggestions or
changes, (b) concept coherence (consistency and understanding of the intervention
elements), (c) quality of delivery, and (d) positive/negative impressions. For our FGs, we will
recruit L/H parents from four NE rural areas. FGs will take place at local community centers.
Drs. Silva and Eisenhauer will coordinate the recruitment of parents (n=8-12 each, n=40
total). FGs will last close to two hours and will be facilitated by a trained bilingual facilitator.
FGs will be led in the language most comfortable to all participants. We will collect feedback
on the cultural relevance of the materials and delivery modes as well as the acceptability of
the intervention. FGs and CWG interviews will be audio recorded and transcribed using a
systematic process to clean and categorize similar FG/CWG comments for data analyses.
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During the adaptation process we will use the expanded framework for reporting
adaptations and modifications to evidence-based interventions (FRAME framework)50 to
record and characterize adaptations necessary to achieve appropriate contextual and
cultural suitability. FRAME includes consideration of when and how modifications occurred,
whether it was planned or unplanned, relationship to fidelity, and reasons and goals for
modification. Data Analysis: See below.
Specific Aim 2: To evaluate the feasibility and preliminary effectiveness of a
technology-delivered FBCO intervention for L/H families in rural Nebraska using RE-
AIM and i-PARIHS. We will randomly assign participants to either the intervention or an
enhanced standard care group (Figure 3). Sample Size Calculation. Sample size is based
on the comparison of changes in BMI z-scores achieved by participants in FC-IVR with
those achieved by participants in FC-workbook condition at 6 months post randomization20.
A total of 46 (23 per group) parent-child dyads achieves 80% power (alpha 0.05) to detect a
significant difference between SC and IVR groups conditions. To account for a 25% attrition
rate at 6-month we will recruit a total of 58 (29 per group) dyads. Participant Recruitment
and Baseline Assessment Procedures. Dr. Hines will coordinate the recruitment of the
participants with the help of CHWs. We will recruit a total of 58 dyads (Table 1). Baseline
visits will take place at local community centers using private rooms. Dyads will complete
informed consent, height, weight and waist circumference assessments, as well as
complete a computer-based survey. Randomization will follow a random-numbers table
(families/staff unblinded). Standard-Care. Families randomized to this group will receive FC-
workbook. No additional materials or intervention contact will be provided. CHWs will follow
a retention protocol to ensure these individuals return to 6-month assessments. Intervention
Delivery. Families randomized to this group will receive the adapted version of the
intervention described above. Drs. Silva and Almeida will monitor IVR completion reports
and assist the student-worker and CHWs in the on-going monitoring and engagement of
participants during the intervention. Measurements and Data Collection. All measures (see
table at PHS section for description) will be collected prior to intervention initiation and at 6
months post baseline (Figure 3). Weight will be assessed using a digital scale calibrated for
accuracy prior to each assessment period using standard weights of a known quantity (e.g.,
100-pound dumbbell). Height will be measured with a stadiometer, calibrated in 0.1-cm
intervals. Waist circumference will be measured with a spring-loaded cloth tape measure at
the level of the iliac crest using the average of the two closest measurements. Other
Measures. Children and parents will complete measures of physical activity98,99, eating
behaviors100, beverage intake101, quality of life102,103 acculturation104,105, and health
literacy106. Parents will also complete home environment107 surveys. During the 6-month
assessment parents will complete program satisfaction surveys and a short exit interview
with a CHW. Feasibility will be assessed according to intervention relevant factors (RE-AIM
dimensions, engagement, attendance and completion rates), cost-effectiveness, cultural
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relevance (aim 1 measures) and acceptability identified in exit survey/interviews to
determine whether intervention is appropriate for further testing. Qualitative Analysis.
Qualitative interviews and FGs will be recorded and transcribed in English or Spanish. The
PI, with assistance from Dr. Eisenhauer and Almeida will construct the interview codebook,
with inductive codes added iteratively by in-depth reading of transcriptions until saturation is
achieved. Transcripts will be double-coded in NVivo by Dr. Eisenhauer, Almeida and the PI.
Inter-coder reliability using Cohens kappa (goal > 0.80) will be assessed. The research team
has extensive experience conducting qualitative investigation20,22,26,51,58,62,67, possesses
local linguistic expertise (Drs. Silva and Almeida, speak Spanish), and will be aided by
bilingual (English-Spanish) CHW staff. Statistical Analysis: The association of the
intervention with the primary outcome of proportion of children reducing BMI z-scores will be
tested using a chi-square test. The degree of association will be summarized using the odds
ratio. If the assumptions of the chi-square test are violated, Fishers exact test will be utilized.
Potential gender, and acculturation scores (external and familial language use, and social
relations) differences will be explored via stratification. Comparisons between groups within
gender will be done using Fishers exact test. Secondary aims outcomes include parent BMI,
waist, PA, sweet beverages intake and eating behaviors, home environment changes and
quality of life. The quantitative outcomes will be summarized using means and standard
deviations or medians and inter-quartile ranges, as appropriate. If categorized, outcomes
will be summarized using counts and percentages. Between group differences at 6-month
will be capture using ANCOVA with the baseline measure as the covariate. If the ANCOVA
assumptions are violated, a t-test (or if indicated, Wilcoxons sum rank test) between group
change scores (6-month baseline measure) will be used. Potential parental engagement (%
of reach, retention and completion) and acculturation scores (language and media use, and
social ethnic relations) differences will be explored via stratification. Comparisons between
groups will be done using Fishers exact test. Significance level is 0.05.
Sources of Data. Data for this research project will be collected from interviews, focus
groups, surveys, and anthropometric measurements (Height and weight), specifically for
research purposes. Interviews and focus groups will be audio recorded and usability testing
will be video recorded, both will be transcribed verbatim for analysis. To analyze qualitative
data, we will use a modified grounded theory approach.
This will involve identifying and naming key concepts from the interview, FG and UT
transcripts, developing a codebook, and having two research team members code
interviews independently, line by line. Dr. Silva will save the digital recordings off to a
password protected encrypted file stored on the UNMC College of Public Health file server,
secured by Windows access controls.
Drs. Silva and Eisenhauer will be the only individuals with access to these password-
protected files. Upon saving the files to the encrypted file firewall protected UNMC database
(OneDrive), the files will be deleted from the recording device. Dr. Silva will download a
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copy to a dedicated folder in the UNMC database granting access to the files to Drs.
Eisenhauer and Almeida for transcription. Speakers in Microsoft word documents will only
be identified by numbers.
Outcome data for children and parents enrolled in the research are outlined in the table and
assessments are projected to take ~35 minutes for children and ~60 minutes for parents. All
the surveys utilized in this study will be in English and Spanish in paper format. Survey
administrators will include the student-worker and four CHWs. The estimated time for each
instrument is approximately 5 to 10 minutes. In Aim 2, participants will complete height and
weight assessments using a calibrated weight scale, as well as a computer-based survey.
The survey will include questions about socio- demographic information, physical activity,
nutrition, health literacy and quality of life. All questionnaires and biomarkers will be entered
in a password-protected database, without personal identification of participant and stored in
OneDrive according to university IT guidelines. The information obtained from the surveys
will also be encrypted and password protected. Drs. Silva, Estabrooks and Michaud will
conduct error-checking procedures on all data to ensure their accuracy and safety.
As we have done in prior studies, a manual of procedures will be developed during the initial
study start-up period that explicitly describes the specific procedures related to the delivery
of focus groups, data collection and safety, and quality assurance for all study stages.
Implementation study
measures:
Variables
Approx. minutes
Baseline
6-Month
Child
Weight
Raw units (Kg),
percentage, BMIz-
scores
3 min
x
x
Height
Height (cm).
3 min
x
x
Waist Circumference
Waist Circumference
(cm)
3 min
x
x
Blood pressure
Systolic and Diastolic
pressure (mmHg)
5 min
x
x
Physical Activity (Godin-
Child Questionnaire99)
Time of vigorous,
moderate, mild
exercise. Score and
category
(active/insufficient)
3 min
x
x
Nutrition (BRFSS fruits
and vegetables100 and
BEVQ101)
Fruit and vegetables
servings and sugar
sweetened beverage
consumption
5 min
x
x
Quality of Life (PEDS-
QL103)
Physical Health and
Psychosocial Health
Score, Sum Score
5 min
x
x
Health Literacy (New
Signal Vital-NVS106)
Health literacy and
Numeracy, Sum score
of and categorized
(limited/adequate)
3 min
x
x
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Acculturation (Short
Acculturation Scale for
Hispanic Youth104)
External language use,
familial language use,
social relations scores,
total score, rank
(low/high)
3 min
x
x
Parent
Weight
Raw units (Kg),
percentage, BMI.
3 min
x
x
Height
Height in cm.
3 min
x
x
Waist Circumference
Waist Circumference in
cm.
5 min
x
x
Blood Pressure
Systolic and Diastolic
pressure (mmHg)
5 min
x
x
Physical Activity (Godin
Leisure Time Exercise
Questionnaire98)
Time of vigorous,
moderate, or mild
exercise. Sedentary
Behaviors. Score and
category (active
/insufficient).
3 min
x
x
Nutrition (BRFSS fruits
and vegetables100 and
BEVQ101)
Fruit and vegetables
servings and sugar
sweetened beverage
consumption.
5 min
x
x
Health Literacy (New
Signal Vital-NVS106)
Health literacy and
Numeracy, Sum score
of and categorized
(limited/adequate)
5 min
x
x
Quality of Life (BRFSS
Healthy Days102)
General health status
Number of Healthy
Days
3 min
x
x
Home Environment
(Comprehensive Home
Environment
Survey107)
Food, Physical activity,
and Media home
environment scores and
total score.
10 min
x
x
Acculturation
(Bidimensional
Acculturation Scale105)
Language and media
use, and social-ethnic
relations scores, total
score and rank
(low/high).
3 min
x
x
Qualitative interview on
process and program
feedback
Feedback and
Satisfaction with
intervention
components
20 min
X
all measures are available in both English and Spanish versions
All questionnaires and biomarkers will be entered into a secure site through the Internet. All
data will be entered in the firewall-protected server. The UNMC Research IT Office instructs
investigators in its use and hosts the REDCap database of project data.
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C. Select any of the following that apply to the research:
Phase I study 
♦ Randomization
Placebo (or non-treatment arm) 
Washout 
Sensitive surveys or questionnaires 
None of the above 
Describe randomization process and schedule
Randomization will occur at enrollment and follow a random-numbers table (families/staff
unblinded).
D. Identify:
1. All procedures, interventions, evaluations and tests performed solely for research
purposes (eg, administration of an investigational drug or a new psychological
assessment instrument; randomization)
With the exception of the standard care condition, all aspects of this study described above
will be performed for research purposes. These include:
1. Eligibility and screening process
2. Monitoring of recruitment and retention of participants
3. Assessments / Measurements
2. All procedures, interventions, evaluations and tests performed for clinical indication
but more frequently than they would be if the subject was not participating in the
research (eg, extra blood tests; additional radiology exams)
We typically do not use assessments taken as part of normal clinical care, however,
information provided by intervention and anthropometric tests performed (e.g. weight,
height) are part of the usual care for both and children in a regular primary care practices.
E. Describe briefly the statistical methods used to analyze the data (or reference the
appropriate section of the detailed protocol or grant).
A mixed-methods feasibility study will be used to address our 2 Aims:
Specific Aim 1 Design and Analyses
Cultural relevance Analysis: We will conduct an assessment of both the original intervention
and the adapted intervention by in-depth interviews and focus groups to assess changes
proposed to match the characteristics and preferences of potential participants. The English
and Spanish versions of the Cultural Relevance Questionnaire (CRQ) and i-PARIHS will be
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used to evaluate original intervention by the Community Workgroup (CWG) as well as to
guide interviews and focus group questions. CRQ evaluates cultural sensitivity (i.e.,
functional, conceptual and linguistic) and ecological validity (e.g., language and context)
using a 5-point Likert scale and open-ended requests on each item to elicit qualitative
observations. CRQ analysis will provide information on four overarching categories: (a)
language's suggestions or changes, (b) concept coherence (consistency and understanding
of the intervention elements), (c) quality of content delivery, and (d) positive/negative
impressions. CWG members will evaluate adapted materials, and Dr. Silva will lead the
training of the CWG on how to use the tool. Materials will be rated by CWG members on a
scale of 1 (Components are not reflected within the intervention) to 5 (All of the components
are reflected within the intervention). The evaluation of cultural relevance consists of three
categories: 1) functional relevance, 2) conceptual relevance, and 3) linguistic relevance of
the intervention for each module, where higher scores indicates a more culturally relevant
material. Interviews and focus groups (FG) will be conducted to assess cultural relevance
(cultural sensitivity and ecological validity), preferences of potential participants, and to see
how satisfied participants and CWG are with (a) delivery mode (i.e. workbook, IVR, in-
person group session), (b) relevancy of information provided, (c) frequency and duration of
interactions, and (d) whether they would recommend the program. Interviews and FG will be
scheduled and conducted by Dr. Silva and will be audio recorded and transcribed using a
systematic process to clean and categorize similar comments for data analyses.
Readability Analysis. We will use two measures of readability: the FRY method and the
Flesh Reading Ease Score (FRES). Our analysis will include a comparison of the readability
level of the original English version and the new Spanish version using the collaborative
functionalist approach.
Usability Analysis. We will use a mixed method, task-based usability assessment to
evaluate our technology components (i.e., IVR and Videos). We will recruit 3 to 6
participants to complete a short questionnaire and receive an introduction to think-aloud
procedure. This procedure allows testing observers to understand and track a participants
thought processes as they navigate one randomly selected intervention session (i.e., IVR
only, IVR plus workbook, or workbook only). A trained bilingual facilitator will lead each
session using a semi-structured interview guide, while Dr. Silva observes and take notes.
Participants will be asked to perform standardized tasks, such as engaging with the IVR
system, completing workbook activities, or setting a goal. After each attempted task, we will
use open-ended questions outlined in the interview guide to elicit participants (1)
expectations for the features functionality, (2) ability to comprehend the information
displayed, (3) ability to navigate to and from the feature, (4) satisfaction with the feature, and
(5) how the feature might be improved. To assess satisfaction, participants will complete the
adapted Computer System Usability Questionnaire (CSUQ) for ease of use, likability of the
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interface, and overall satisfaction. Each session will be video-recorded using QuickTime
Player (Apple Inc., Cupertino, CA) and transcribed. Deidentified transcripts will be imported
into NVivo 10 (version 10; QSR International, Burlington, VT) for coding and analysis to
address design, efficiency of use, and content and terminology.
Tracking and Monitoring of Adaptations. During the adaptation process we will use the
expanded framework for reporting adaptations and modifications to evidence-based
interventions (FRAME framework) to record and characterize modifications and adaptations
necessary to achieve appropriate contextual and cultural suitability. FRAME includes
considerations of when and how modifications occurred, whether it was planned or
unplanned, relationship to fidelity, and reasons and goals for modification. We will align
reasons and goals for adaptations to our overarching conceptual model and content and
analyze meeting minutes, field notes, and decision-records along the components of the RE-
AIM and iPARiHS models. This will provide information on adaptations that were made due
to beneficiary characteristics (i.e., L/Hs), recipient and organizational characteristics,
contextual factors, or facilitation factors.
Data Analysis. We will use triangulation of quantitative (CRQ, CSUQ and surveys) and
qualitative (CRQ, CWG and FG feedback) methods from different sources (i.e., CWG
members, providers, community partners staff, and L/Hs) to increase the likelihood that the
refined intervention will meet the needs of participants while also adhering to the evidence-
based principles at the core of the program. Focus groups will be audio recorded, and
usability testing will be video recorded; both will be transcribed verbatim for analysis. To
analyze qualitative data, we will use a modified grounded theory approach. This will involve
identifying and naming key concepts from the interview, FG and UT transcripts, developing
a codebook, and having two research team members code interviews independently, line by
line. Co-Principal Investigator Dr. Silva will save the digital recordings off to a password-
protected encrypted file store on the UNMC College of Public Health file server, secured by
Windows access controls. Dr. Silva will be the only individual with access to these password-
protected files. Upon saving the files to the encrypted file store, the files will be deleted from
the recording device. Upon saving the files to the encrypted file firewall protected UNMC
database (OneDrive), the files will be deleted from the recording device. Dr. Silva will
download a copy to a dedicated folder in the UNMC database, granting access to the files to
the student worker and Dr. Eisenhauer for transcription and analysis. Speakers in Microsoft
Word documents will only be identified by numbers.
Specific Aim 2 Design and Analyses
Table 1 presents our implementation evaluation measures and analyses
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RE-AIM
Measures
Data Sources [person
collecting]
i-PARIHS Indicators
Reach
- Participation Rates
- Characteristics Participants
vs. Non-participants
- Reasons for non-
participation
- IVR completion and dropout
rates
- Qualitative feedback on
barriers/facilitators to
participating
-Recruitment/enrollment/subje
ct tracking logs (including
reasons for non-participation
or non-eligibility) [CHWs]
-Demographic and clinical
data from intake surveys
(Redcap) [Student Worker,
CHWs]
-Qualitative interviews with
participants, [PI Silva, CHWs]
Selected i-PARIHS constructs
related to the RE-AIM
dimensions will guide the
qualitative interviews with
patients and staff
Selected constructs will
include:
Facilitation: IVR and group
based sessions and workbook
facilitation strategies;
Innovation: adaptation to
deliver strategies to L/Hs in
the context of rural NE
Recipients: perceptions of
participants (Beneficiaries),
and staff (Recipients)
Context: documentation of the
capacity (human and financial
resources); assessment of
support from the leadership at
the state and local levels
Effectiveness
-Primary outcome (BMI z-
score) and secondary clinical
and self-management
outcomes (Table 2) by
control/IVR
-Comparison of outcomes in
subjects who withdraw vs.
complete intervention
-Recruitment/enrollment/subje
ct tracking logs (including
completion, dropout and loss
to follow-up rates/reasons)
[CHWs]
-Clinical data forms and
surveys at 0,6 months [SW,
CHWs]
Adoption
- Staff and leaderships
perceptions about delivering
FBCO program via IVR and
group sessions
-Qualitative interviews with
staff and leadership [Dr.
Eisenhauer , PI Silva]
Implementation
- IVR completion reports;
group session attendance and
observation reports;
proportion of content delivered-
as intended (fidelity)
- Changes made during the
implementation process
(adaptation) tracked by the
FRAME
- Number of Calls completed
and contact hours
- Participant satisfaction
- Qualitative feedback on
barriers/facilitators from
L/Hs/staff using i-PARIHS
constructs
-IVR completion forms (IVR
System) [Dr. Almeida]
-IVR logged call duration (IVR
System) [Dr. Almeida]
- Participant Satisfaction
survey [SW, CHWs]
-Qualitative interviews with
participants, staff [Dr.
Eisenhauer , PI Silva]
Maintenance
- Characteristics of completers
vs non-completers
- Intention to continue the
intervention
- Qualitative feedback on
barriers/facilitators from
participants/staff and
leadership using i-PARIHS
constructs
-Demographic and clinical
data from intake surveys [SW,
CHWs]
-Clinical data forms at 0,12
months [CHWs]
-Qualitative interviews with
participants, facilitators, staff,
and health authorities [Dr.
Eisenhauer, PI Silva]
Sample Size Calculation. Sample size is based on the comparison of changes in BMI z-
scores achieved by participants in FC-IVR with those achieved by participants in FC-
workbook condition at 6 and 12-month post randomization. A total of 46 (23 per group)
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parent-child dyads achieves 80% power (alpha 0.05) to detect a significant difference
between the FC-workbook and FC-IVR conditions, based on the relative BMI z-score
differences (0.05) and standard deviation related to 6-month BMI z-score reduction for FC-
IVR (0.06). To account for 25% attrition rate at 12-month, we will recruit a total of 58 (29 per
group) parent-child dyads.
Cost Analysis: Costs will be assessed using time tracking spreadsheets and focused
primarily on Aim 2 as it relates to the intervention delivery, though costs of participant
recruitment will also be tracked using material and staff time to determine dollar amounts.
Dr. Michaud will complete A simple cost benefit analysis by assessing intervention
implementation costs at 6-month post baseline by BMI z-scores reduction categories of
unchanged, ≤ 0.1, 0.1-0.25 and ≥ 0.25, respectively.
Qualitative Analysis. Qualitative interviews will be recorded and transcribed in English or
Spanish. The PI, with assistance from Drs. Eisenhauer and Estabrooks, will construct the
interview codebook, with inductive codes added iteratively by in-depth reading of
transcriptions until saturation is achieved. Transcripts will be double-coded in NVivo by Dr.
Eisenhauer. Inter-coder reliability using Cohens kappa (goal > 0.80) will be assessed. The
research team has extensive experience conducting qualitative investigation, possesses
local linguistic expertise (Drs. Silva speak Spanish), and will be aided by community
partners bilingual (English-Spanish) CHW staff.
Statistical Analysis: Descriptive, parametric, and non-parametric statistical methods will be
used to compare continuous and categorical variables among the intervention groups at
baseline. Data will be examined for the presence of outliers, violations of normality (for
those continuous variables) and missing data. Major violations of normality will be corrected
with an appropriate transformation procedure or non-parametric methods . Multi-level mixed
effect models will be employed to control errors of non-independence, heteroskedasticity
caused by parent-child dyad heterogeneity, and potential covariates to control to detect the
BMI z-score reduction differences between the two conditions. In its simplest form, the
model generally can be shown as:
BMIzscoreit=µ+αi+Xijt
'β+Wiσ+ΤTt+θdi&#8901;Tt+νit.
All measures are obtained for 3 time periods: baseline, 6, and 12 months. The dependent
variable is BMIz score for participant i at time point t. The unobserved participant-level
heterogeneity that isnt time dependent is represented by αi, is allowed to vary by parent-
child-dyads and to be a random variable. The Xit are time-period-level covariates and the Wi
are particpant-level covariates. The model also contains treatment group indicators di, and
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time period indicators Tt. Relative treatment effect between conditions will be captured by
coefficient θ and is the variable of interest. Sensitivity analysis will be conducted to examine
the robustness of the mixed effect model across different random-effect distribution
specifications (e.g., normal, finite mixture of normal etc.). Additional outcomes (e.g., parent
BMI, waist circumference, PA, sweet beverages intake and eating behaviors, acculturation,
home environment changes and quality of life) will be analyzed using ANCOVA with the
baseline measure as the covariate. If the ANCOVA assumptions are violated, a t-test (or if
indicated, Wilcoxons sum rank test) between group change scores (6 or 12 month measure
and baseline measure) will be used. Significance level for all tests is 0.05. Analyses will be
performed using R 3.6 (R Core Team).
F. Does this study involve the collection of blood, urine, saliva or other human
biological material (HBM)?
No
DRUGS, BIOLOGIC DRUGS AND DEVICES
13. Drugs and Biologic Drugs 
1. Does this research involve the use of drugs or biologics?
No
14. Devices 
1. Does this research involve a medical device(s)?
No
CONFIDENTIALITY AND PRIVACY
15. Confidentiality and Privacy 
A. Describe where research data will be stored. Check all that apply.
♦ On a secure server at UNMC, CHMC, Nebraska Medicine, and/or UNO (including
REDCap)
♦ On a secure cloud server - Specify the secured cloud serve:  UNMC OneDrive
On a firewall protected database accessible through the internet - Specify who has
administrative responsibility for maintenance of the server: 
On an encrypted, password protected local hard drive 
On an encrypted, password protected portable computer 
On an encrypted, password protected flash drive 
♦ In hard copy
Other 
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a. Please provide justification for use of hard copies
Data collection will be performed in rural areas that may have limited access to internet.
Thus we may need to collect consents and survey printed forms (hard copies). Hard copies
of data will be kept locked in a file cabinet in the locked office of the study coordinator or the
locked office of the PI, at the College of Public Health.
b. Will hard copies will be transported from one site to another, on or off campus?
Yes
c. Describe how they will be secured during transport
Data will be transported in a locked briefcase or file box.
B. Will any of the following subject identifiers be recorded (at any time) in association
with the research data?
Yes
1) Indicate the subject identifiers that will be recorded. Check all that apply.
♦ Name
♦ DATES (e.g. date of study visit, date of sample collection, birth, admission, discharge)
♦ Postal address information: street address, city, county, precinct, ZIP code
♦ Telephone numbers
Fax numbers 
♦ Electronic mail addresses
Social Security numbers 
Medical Record numbers 
Health plan beneficiary numbers 
Account numbers 
Certificate/license numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
Device identifiers and serial numbers 
Web Universal Resource Locators (URLs) Internet Protocol (IP) address numbers 
♦ Biometric identifiers, including finger and voice print
♦ Full face photographic images [and any comparable images]
No Identifier 
2) Will a unique subject identifying number (e.g., S1, S2, S3), characteristic or code be
used to link data to any of the identifiers listed above?
Yes
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a. Where will the key (that links the unique subject identification code to the subject's
name or other identifier) be stored?
The key will be housed on a password protected computer in a password protected file in an
electronic location that is separate from participant data.
b. Does the code number include the subject's initials or other subject identifier as part
of the code?
No
3) What is the justification for recording the specific subject identifiers listed above?
Check all that apply.
♦ Schedule appointments
Collect continuous clinical information from the medical records 
♦ Follow-up with subjects
Link stored tissue with subject identification for it to be withdrawn in the future if requested 
♦ Compensation
Other. Explain. 
4) How long will the subject identifiers be maintained in association with the research
data?
The recording will be maintained until the final report for the sponsor is generated and the
associated manuscripts are published.
5) How will all of the identifiable research data be destroyed (e.g., all identifiers
stripped from the data and destroyed, hard copies shredded etc) when the identifiable
data is no longer required?
All electronic data will be destroyed with the assistance of the ITS and in accordance with
UNMC Computer Use and Electronic Information Security Policy N0. 6051.
C. Will research data that contain subject identifiers be disclosed to:
Other investigators at UNMC, NM, UNO or CHMC who are not listed in Section I of this
application?
No
2. Investigators outside of UNMC, NM, UNO or CHMC?
No
3. Will research data that contain subject identifiers be disclosed to any commercial
sponsor or contract research organization (CRO), or to any other external organization
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or entity (e.g., NCI cooperative groups)?
No
D. What provisions will be in place to protect the subject's privacy? Check all that
apply.
♦ Ensuring that only personnel listed on the IRB application Section I.3(A-E) are present
during the consent process.
♦ Ensuring that the fewest number of individuals possible are aware of the subject's
participation in the research.
♦ Ensuring that the research activities are performed in as private of a place as possible.
Other. Explain. 
E. Does this research involve data banking at UNMC, NM, UNO or CHMC, or by an
outside organization (e.g. NCI Cooperative Group, pharmaceutical company) for future
research that is not related to this study?
No
RISK/BENEFIT ASSESSMENT
16. Potential Risks 
What are the potential risks associated with each research procedure, intervention,
evaluation and/or test? If data are available, estimate the probability that a given harm
may occur and its potential reversibility.
Considering the study rationale, population, procedures, and the risk: benefit profile as
outlined, the overall risk level for participation in this study is considered minimal risk.
For the children and parents, it is possible that completing the assessments could cause
stress or anxiety; however, the questionnaires contain minimally sensitive questions.
Nonetheless, all community based project staff and university research assistants will be
trained to deal with this anticipated anxiety and each individual will always have the right to
refuse to participate or to answer any questions on the survey. Furthermore, children and
parents from the target population of the proposed study could have relatively little recent
experience with regular moderate intensity physical activity.
The risks associated with participation in focus groups, usability testing, interviews and
surveys completion (CWG and Aim 1) are considered minimal. The research team will make
it clear to participants that note taking and audio/video recording will be employed during the
individual UT testing, focus group discussion and interviews, and obtain each member's
agreement to this procedure during the consent process. In the FG sessions, participants
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will be seated in a circle, to maximize face-to-face contact. Additionally, the audio/video
equipment used to record the FG and UT discussions, and interviews will be placed in the
most unobtrusive way in order not to inhibit participants interaction. FG and UT participants
will receive assurance from the research team (in written and verbal form) that all
information gathered, the recording and the resulting data, will be subject to the same
rigorous safeguards and formal assurances of confidentiality and anonymity employed by
other research techniques.
Parent from dyads participants from the target population of the proposed study will have
relatively little recent experience with regular moderate intensity PA and may suffer from
adverse health conditions such as hypertension, or high blood cholesterol. The dyads
participants will be asked to initiate both a healthier diet and a graduated, moderate intensity
exercise program. All PA programming will be tailored to individual family needs and levels
of fitness. Each participant will begin with shorter bouts of moderate intensity PA and build
to approximately 35 minutes for parents and 60 minutes for children of PA, 5 days per week
by the conclusion of the 6-month trial. Although the initiation of inappropriate levels of high
intensity PA could be harmful to such a population, small increases of moderate intensity PA
over time has many benefits for this population, not the least of which is a reduced risk of
mortality. Further, physical inactivity is a large risk factor for many adverse health events in
this population and supervised moderate PA is safe even for older adults. Unfortunately,
inappropriate levels of PA could lead to musculoskeletal injuries during or following PA, and
potential cardiovascular, pulmonary, or related adverse events or hospitalizations, and in
extreme cases death. Although, there is a larger risk from sustained physical inactivity, the
risks of injury resulting from participating in the prescribed exercise regimens will be
minimized in several ways. To avoid injury, participants will be instructed to devote the first
and last 5 minutes of each physical activity session to warming-up and cooling-down, as
well as setting realistic short term goals (i.e. parents:15 min. 3 days/week for 2 weeks; 15
min. 5 days/week for 2 weeks; 30 min. 3 days/week for 2 weeks; 35 min. 5 days/week for
life). The purpose of the warm-up is to slowly bring the participants heart rate up the desired
training heart rate. The cool-down is designed to slowly decrease the participants heart rate
down from the training heart rate. The dietary recommendations are consistent with healthy
eating patterns recommended by organizations such as the American Heart Association to
produce a balanced diet and gradual weight loss, so are not anticipated to produce any risk
beyond everyday living.
The research may also include risks to the privacy and confidentiality of protected health
information or participants weight. The seriousness of this risk is low and several steps will
be taken to ensure confidentiality. Further, based on the high security on internal computer
hard and software, the likelihood of these risks are low. Each individual will have the right to
refuse to participate or to refuse to provide a HIPPA authorization and such refusal will not
affect a patients health care.
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17. Risk Classification 
What is the overall risk classification of the research?
♦ Minimal risk
Greater than minimal risk 
18. Minimization of Risk 
A. Describe how the subjects of the research will be monitored by the investigators and
other research personnel to ensure their safety.
Adequacy of protection against risks: The proposed research presents no more than
minimal risk to study participants. Families who meet the preliminary requirements will be
required to sign a written informed consent form (parent) and verbal assent (child). The
study and the consent form will be thoroughly described to each participant prior to
enrollment. Any questions that arise and cannot be answered by trained recruiters on the
spot will be routed to the principal investigator (Dr. Silva) and will be answered, with ample
time for the patient to consider participation. Recruiters supervised by the Dr. Silva will
ensure the participants comprehension of the study and obtain the participants signature. A
copy of the document will be provided to the patient, and the original will be retained in the
study file.
1. The risks of musculoskeletal injuries or cardiovascular events that accompany
inappropriate increases in high intensity PA will be thoroughly described to each
study dyad participant during the informed consent and assent process. All dyads
participants will receive details to inform them of the studys purpose, protocols, and
their responsibilities should they choose to participate.
2. The risks associated with data storage will be thoroughly described to each study
dyad participant during the informed consent process. All dyads participants will
receive details to inform them of the studys purpose, protocols, and their
responsibilities should they choose to participate.
An assessment of potential adverse events will be used to document potential problems and
if those problems were related to participation in the program. The risks of injury resulting
from participating in the prescribed exercise regimens will also be minimized in several ways
including:
1. Exclusion from the study of any person with overt contraindications for PA
2. Individualized exercise prescription based on the person's health background and
history.
3. Careful instruction of participants through interactive technologies.
4. A gradual approach to increasing exercise amount and intensity of physical activity
as recommended by the ACSM.
5. Targeting physical activity intensity in the moderate range, and tailoring the intensity
level to the needs and abilities of each participant, including age.
6. Careful attention to warm-up and cool-down procedures as well as to the experience
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of physical discomfort during exercise.
The risks to privacy and confidentiality will also be carefully described to each study
participant during the informed consent process, and all uses and disclosures of protected
health information will be detailed in the authorization document as well as the consent
form. To keep the information safe and protected, the following steps will be taken:
1. Participants will receive a unique study ID number. Only approved personnel (Dr.
Silva) can match the individuals to the study ID number and related results.
2. Strict security safeguards will be in place to reduce the chance of misuse or
unplanned release of information. Steps we take include password protected access
to databases, and storage of paper documents in a locked file cabinet.
3. Rules for publications: If research results are published, individual participants will
not be identified by name or any other personally identifiable information.
4. If physical test results indicate possible health concerns, participants will be referred
to the Study Healthcare Liaison, Dr. Eisenhauer, and this information may be shared
with their primary physician if they wish to do so.
Additionally, during the parent informed consent process, potential CWG, FG and UT
participants will be assured that the information shared during the think-aloud procedure or
group discussions will be de-identified and anonymous. As such, participants will only use
first names or nicknames when checking in to the UT or FG and when referring to self or
others during the FG. To further protect confidentiality, the research team will remind
participants at the start and end of the UT and FG that what is discussed during this process
is to be kept confidential. To maintain this confidentiality, FG participants will be asked not to
disclose the first names of participants outside the focus group. In the video recordings from
the UT the camera will be positioned to not show participants face, only the interaction with
phone/computer screen. Finally, the files of video recordings from the UT and audio
recordings from the FG will be stored and protected under a locked room in a password
protected computer file to further protect participant information from being shared.
B. Describe how the data collected will be monitored to ensure the safety of subjects.
Identify who will perform the ongoing data and safety analysis, and describe the
frequency of data analysis. If there is an independent Data and Safety Monitoring Board
(DSMB) provide the charter, or describe (1) the composition of the DSMB membership,
(2) the frequency of DSMB meetings and reports.
The study will monitor the medical safety of participants. At the screening stage, potential
study participants will be monitored to determine safety to participate in the trial. Safety will
also be monitored during the conduct of study assessments. Safety during the conduct of
the study intervention will also be monitored. Finally, the study monitors adverse events to
assess their potential relationship to the intervention. Events will be reported to the Data
Safety Monitoring Board (DSMB).
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A Data Safety Monitoring Board (DSMB) will be established and charged with the
responsibility to monitor all aspects of the study. Dr. Eisenhauer will act as the Study
Healthcare Liaison (SHL) and report to the DSMB for issues related to participant safety.
See uploaded file "Data and Safety Monitoring Plan."
C. Describe the auditing plan for research conducted. Identify who will conduct the
audits and specify the audit frequency.
The study will be audited beginning six months after the start of accrual of participants and
then annually. Individual Roles and Responsibilities: Each audit will include monitoring of:
compliance with informed consent and eligibility requirements, recruitment plan according to
protocol, expected and actual accrual, protocol violations, participant withdrawals from the
study, adverse events, baseline participant characteristics, interim analysis findings
prepared by the study statistician (Dr. Kachman), and appropriate follow-up of data
collection according to protocol. Dr. Kachman will prepare and sign off the relevant reports,
with data void of participants names. The reports will then be signed off by the PI and
submitted to the DMSB. The DMSB will be provided with a summarized report with access
to raw data if needed.
See uploaded file "Data and Safety Monitoring Plan." for a summary of review/reporting
activities outlined on page 3.
D. Describe the specific subject withdrawal criteria.
Subjects are free to withdraw at any point in the study. No withdraw by the study team are
anticipated.
E. Describe the stopping rules for the research (e.g., the specific criteria for halting or
early termination of the study).
There are none given the research minimal risk. Subjects can stop at any time.
F. Describe plans and resources available to promptly address any subject injury.
If a subject is injured or has a medical problem as direct result of being in this study, the
subject will be instructed to immediately contact a member of the study personnel listed at
the end of the consent form.
19. Potential Benefits to the Subject 
Is there the prospect for direct benefit (eg, research on diagnosis or treatment of
disease)?
Yes
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Describe potential benefits to the subjects that may reasonably be expected from
participation in the research, if any. If there are therapeutic and non-therapeutic
components of the research, address anticipated benefits to subjects that may
reasonably be expected from each of these components.
Parents and children in this study should receive many benefits by participating. Based on
the literature cited in the Significance section participants who lose weight can expect the
following:
1. Improved Cardiovascular Function.
2. Improved physical quality of life.
3. Decreased risk of future cardiovascular events.
4. Decreased risk of an obese adulthood.
Furthermore, all dyads participants may learn more about their own health. They will receive
information regarding their weight, physical activity and dietary behaviors. This information
could be helpful on their overall well-being and even identify potential health risks.
20. Potential Benefits to Society 
Describe the potential benefits to society that may reasonably be expected to result
from this research.
There is an urgent need to better understand and mitigate childhood obesity related
disparities. However, despite growing number of publications and funding in this area, very
little is understood and the disproportionate obesity related burden suffered by L/Hs children
continues to grow. As such, more of the same type of research will not help solve this
complex problem and our innovative collaborative approach seeks to help move the field
further in its understanding of health disparities.
Additionally, the development of a successful intervention has the potential to provide a
viable alternative that can be used in rural communities across the United States and
abroad in rural Spanish speaking communities. Therefore, we believe findings from the
proposed research will contribute to a limited body of knowledge regarding the feasibility
and acceptability of delivering new culturally appropriate technology-delivered family-based
childhood obesity (FBCO) programs to a population that is traditionally absent from the
development process. Furthermore, we believe that by engaging the target population in this
process we will have a higher chance that L/Hs families living in rural Nebraska will enroll
and engage in future programs. Childhood obesity is one of the greatest health problems
facing this rural population and the knowledge gained from the current proposal has the
possibility of helping to slow down and even reverse the current obesity epidemic among
rural L/Hs children.
Also, the proposed study will provide details on a novel application of a cultural adaptation
model that could provide a blueprint for future intervention development and testing when
considering translation to address health disparities. The importance of this knowledge has
implications for both individual behavior change, but also for system application and
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delivery. As noted previously, the risks to participating are minimal; therefore would be
reasonable in relation to the anticipated benefits to research participants and others.
ALTERNATIVES TO PARTICIPATION
21. Alternatives to Participation 
1. Describe the likely care the subject would receive at this institution were he/she not
to participate in the research. If there are more than one reasonable courses of
treatment briefly describe.
The subject can choose not to participate. The standard of care condition in this study is
similar to the care an individual might receive when they are not participating in the
research.
2. Is the potential benefit of the research at least as good as the potential benefits of
the alternatives described above?
Yes
3. Are there any reasonably available alternatives outside this institution which would
have the potential for providing benefit to the subjects outside the research context?
Yes
a. What are the reasonably available alternatives?
Families may seek out services that promote children weight loss without participation in the
study.
4. Would any of the study procedures or courses of treatment in the protocol be
available to the subject if they elected not to participate?
Yes
a. Explain.
Standard of care for childhood obesity is available in the community to the prospective
subject should they choose not to participate.
5. Would the research intervention be available outside the context of research?
No
6. Are there any treatments that the subject would be denied as a consequence of
participating in research that he/she would have received had he/she not participated?
No
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7. How do the risks of the research compare with the risks of alternative procedures or
courses of treatment described above?
The potential benefits of the Family Connection Program (e.g., weight loss, improved BMIz
in children) are much greater than the current standard of care for childhood obesity, as
evidenced by our published pilot data20. The risk associated with existing standard-care for
childhood weight management is similar to those associated with the proposed intervention.
They are minimal.
FINANCIAL OBLIGATIONS AND COMPENSATION
22. Financial Obligations of the Subject 
A. Who will pay for research procedures, interventions, evaluations and tests? Check
all that apply.
Sponsor 
♦ Grant
CRC, CCTR 
Costs or fees waived by Nebraska Medicine, UNMC- P, CHMC or CSP 
Department/Section funds 
Other. Explain 
B. Will any of these procedures, interventions, evaluations and tests will be charged to
the Subject, the Subject's health insurance, or Medicare/Medicaid?
No
C. Are there any other financial obligations that the subject will incur as a result of
participating in the study?
No
23. Compensation to the Subject for Participation 
A. Will the subject receive any compensation for participation?
Yes
1. Describe the form of compensation, dollar amount (if applicable) and the prorated
compensation plan (if applicable).
Participant will receive a $25.00 gift card for completion of any focus group and $25.00 for
completion of usability test and $25.00 for intervention assessments. To enhance retention,
in addition to receiving full details on the results of their anthropometric measurements, both
parents and child participants who complete each of the 3 study visits (0, 6 and 12 month)
will receive a $25.00 gift card each as a thank you for their time for a possible total of $50.00
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per family per visit - $150 total over 12 months if they complete all 3 visits.
CWG participants will be compensated for their involvement in this research study. A gift
card of $25 will be provided for each assessment (survey), meeting, and interview
completed.
PRIOR REVIEW
24. Prior IRB Review 
A. Has this study (or one substantially similar) been previously submitted to the UNMC
IRB (or the Joint Pediatric IRB) and then withdrawn by the investigator for any reason?
Yes
1. Describe why the study was withdrawn.
Yes. Last year we got closer to the NIH funding line with our R21 proposal and requested an
expedited review in order to respond to the JIT request that was granted a pending-funding
IRB approval under the protocol 634-19-EP. Unfortunately, due budget cuts our project was
not funded at that time and the IRB protocol was re-classified as withdrawn in January 28,
2020.
2. Describe changes made to the research plan prior to the current submission.
Minor changes were made after NIH review following reviewers recommendation, such as:
Expand study area by increasing number of communities participants (from 1 to 4
partners health departments) with increased the number of focus groups participants
for Aim 1.
Aim 1 modification to include more detailed approach on procedures for intervention
cultural adaptation.
Changes on research team composition.
B. To the best of your knowledge, has this study (or one substantially similar) been
considered by another IRB and disapproved?
No
SUBJECT IDENTIFICATION & RECRUITMENT
25. Method of Subject Identification and Recruitment 
A. Will prospective subjects be identified through initial contact by the investigator?
Yes
1. Identified through: Check all that apply.
Clinic 
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Hospital inpatient units 
Previous research participants 
Investigator or clinic databases or registries 
Hospital Opt-In Database (thru Nebraska Medicine, BMC or CHMC Conditions of
Treatment) 
School records 
Support groups, or other Interest Groups 
♦ Other. Explain.  Health Departments referral list for stakeholders and CHW staff. Target
population recruitment sample will be draw by CHW from their usual covered population.
2. Describe how the research staff has ethical access to the potential subjects?
The community health workers (CHW) have access to this target population, participants will
be recruited through direct contact by CHWs that already work with those families.
Stakeholders will be recruited for interviews based on list provided by each partner Health
Department Districts and the State of Nebraska Health Department (DHHS) as the directors
will inform whom may be a key informant in their organization - all employers contact are
already public record information.
3. Who will initially screen potential subjects to determine eligibility?
Investigator with an existing clinical relationship 
♦ Investigator with other legitimate access
Investigator whose professional responsibilities that require access to names of potential
subjects 
Honest broker (thru Nebraska Medicine or Bellevue Medical Center COT Opt-in database) 
Research coordinator or other person without ethical access 
B. Will prospective subjects make the initial contact with the research personnel to
inquire about the study?
Yes
1. Potential Subjects learn about the research through: Check all that apply.
♦ Referral by clinician or other parties specifically for the research
♦ Printed advertisements (including bulletins, newsletters, posters, fliers, and magazine or
newspaper ads)
♦ Radio and Television advertisements
♦ Electronic advertisements (including social media or other on-line venue)
♦ Word of mouth
♦ Public UNMC study database
Other. Explain. 
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C. Will this study be listed in the clinical trial registry at www.clinicaltrials.gov?
Yes
1. Provide the NCT#.
NCT04731506
2. Identify who holds the NCT#
♦ PI
Sponsor 
OBTAINMENT OF INFORMED CONSENT
26. Waiver or Alteration of Informed Consent 
A. Is a complete waiver or alteration of consent requested?
No
27. Waiver of Signed Consent 
Is a waiver to obtain signed consent requested?
Yes
1. Identify the type of waiver requested:
Waiver of signed consent where the principal risk would be associated with a breach of
confidentiality (45 CFR 46.117(C)(1)(i)) 
♦ Waiver of signed consent where written consent is normally not required outside the
research context (45 CFR 46.117(c)(1)(ii); 21 CFR 56.109(c))
Waiver of signed consent if the subjects are members of a distinct cultural group or
community in which signing forms is not the norm (45 CFR 46.117(c)(1)(iii) 
WAIVER OF SIGNED CONSENT WHERE WRITTEN CONSENT IS NORMALLY NOT
REQUIRED OUTSIDE THE RESEARCH CONTEXT (45 CFR 46.117(c)(1)(ii); 21 CFR
56.109(c)
1. Do any of the research tests and procedures involve more than minimal risk to
subjects?
No
2. Does the waiver apply to:
All subjects 
♦ A subset of subjects - describe the characteristics of these subjects  Only for participants
of the focus groups and usability test.
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3. Does the research involve any procedures for which written consent would normally
be required outside of the research context?
No
28. Child Assent 
A. Is a waiver of child assent requested?
No
29. Process of Informed Consent 
A. When will the prospective subject/parent(s)/guardian(s)/LAR be approached relative
to their/the subject's actual participation in the study?
Prior to their actual participation - during eligibility screening before assessment data is
collected.
B. Where will informed consent be obtained, and how will the environment be
conducive to discussion and thoughtful consideration?
We will collect 3 different types of consent for each phase of this study. The data collection
steps related to Aim 1 (Focus groups and usability tests) will use narrative consent. For the
data collection related to Aim 2 (clinical trial), we will still use an in-person printed signed
informed consent. The narrative and the informed consent will be emailed or texted to them
and then reviewed again by the research staff or CHWs to ensure understanding (during the
screening and recruitment process, the CHW ask the potential participants if they would like
to receive a copy of the consent by text, and communication by text will only occur with the
participants that stated they want to receive a copy of the consent in this way). The remote
inform consent will be emailed or texted to them via the DocuSign link and then reviewed
again by the research staff to ensure understanding.
Sufficient time will be allowed for a complete understanding of the study and for the subject
to ask questions about the study and his participation. All interested individuals will have the
opportunity to review the informed consent at home, prior to phone screening, focus groups
and usability tests, and then prior to their initial visit, if the individual has questions about
what is stated in the informed consent, he/she will have the opportunity to discuss those
questions with a member of the research team on a one-on-one basis. The individual may
then choose to provide or not provide verbal consent for phone screening, focus groups and
usability tests, and to sign or not to sign in-person the informed consent for the trial.
C. Who will be involved in the process of consent and what are their responsibilities?
All potential participants will receive a recruitment packet delivered by their Community
Health Worker (CHW) to include the narrative consent for contacting potential participants,
discussing the specifics of the study, answer any questions, obtain verbal consent for
schedule screening, determine initial eligibility, assess whether the individual wishes to
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participate, and if so, schedule an eligibility/in-person screening visit. Interested participants
will be will receive a pre-assessment packet delivered CHW with the informed consent for
the trial and instructions for their initial visit approximately 10 days before their initial visit.
During the recruitment and screening, trained CHW will review the informed consent and
answer any questions the patient may have about the program. The investigators listed as
authorized to document consent have sole responsibility for obtaining and documenting the
obtainment of informed consent, and once the informed consent is signed in person, they
will conduct the screening measurements.
D. How much time will be allotted to the process of consent?
Individuals will have several days to review both the narrative informed consent for focus
groups and usability tests, and the informed consent for the trial. They will have the
opportunity to ask questions of the research staff, and will be given as much time as needed
to review and ask questions in person at the initial screening visit.
E. How will the process of consent be structured for subjects who are likely to be more
vulnerable to coercion or undue influence?
Participants will be given as much time as needed time to ask questions about the consent
process and provide feedback on their understanding of the study and procedures.
Participants will also have the opportunity to discuss participation with family or friends.
F. Will non-English speaking subjects be enrolled in this research?
Yes
Describe the plan to conduct the process of informed consent in the language of the
subject/parent(s)/guardian(s)/LAR
Our research team that will be responsible for the consent possesses local linguistic
expertise (Drs. Silva and Almeida, are fluent in Spanish), and will be aided by RHDs
bilingual (English-Spanish) CHW staff. Consent will be provided in their preferred language
(English and/or Spanish).
G. How will it be determined that the subject/parent(s)/guardian(s)/LAR understood the
information presented?
Eligible participants must have capacity to give informed consent and children the assent.
This will be determined by the study staff during the phone contact, as well as the in-person
visit. Participants must be able to articulate in their own words what the study is about, and
what they might be asked to do to participate. Only when the investigator is satisfied the
subject comprehends all of the elements of informed consent will they provide verbal
consent for screening, and sign the consent form for the trial.
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30. Documentation of Informed Consent and Assent 
Select who will obtain consent from the subject/parent(s)/LAR.
Almeida, Fabio
Brito, Fabiana B
Eisenhauer, Christine M
Favero Alves, Thais
Ochoa-Rojas, Daisy
Santos, Natalia B
31. Consent Forms and Study Information Sheets 
Indicate the type of consent forms and study information sheets to be used in this
research. Check all that apply.
♦ Adult consent form
Legally authorized representative (LAR) consent form 
Parental/Guardian consent form 
Youth study information sheet 
♦ Child study information sheet
Adult study information sheet (decisionally-impaired) 
Screening consent form 
Addendum consent form 
♦ Other. Explain.  Narrative consent for focus group and usability test
32. Information Purposely Withheld 
Will any information be purposely withheld from the subject during the research or
after completion of the research?
No
RESOURCES
33. Describe the resources available to safely conduct this study at each study
sites specified in Section I.7. 
Health Departments (CDHD, ECDHD, TRPHD, CAPWN) will provide adequate space to
allow for physical privacy when the participants discuss their informed consent and have
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their risk assessments taken. All four Health Departments has an Automated External
Defibrillator on site in the event of an emergent cardiac event. The PI (Dr. Silva) and at Dr.
Eisenhauer will be at all for CWG in-person meetings and focus group, and the trained
CHWs will present for participants in obtaining informed consent, conducting trainings for at
home assessments. The PI and Dr. Eisenhauer are registered nurses, and the CHW are
trained to provide first aid and emergency response action if needed. All investigators at
each UNMC campus (Norfolk, Omaha) have password protected laptops, IT support, and
private, locked office space. The principal investigator has two digital audio recorders. The
grant will permit purchase of scales, stadiometers, iPads, and other equipment needed for
baseline biomarker measures taken at the assessment points. A locked briefcase will be
used to transfer hard copies of written study materials from the data collection site to the
college.
Please see "Facilities and Other Resources" file from NIH proposal uploaded for more
information.
LITERATURE REVIEW
34. References 
Provide a full listing of the key references cited in the background (Section II.3). The
references should clearly support the stated purpose of the study.
Please see "Bibliography and References" file from NIH proposal uploaded.
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SECTION III
SUBMISSION DEADLINE
A. Full Board Review: 
The IRB meets twice monthly, on the first and third Thursday of the month, with the
exception of January and July when the IRB meets only on the third Thursday of the
month. No more than 15 applications (e.g., initial review of a new study, re-review of a
tabled study) will be reviewed at each meeting. All reviews are performed on a first-
come first-served basis. The IRB meeting schedule and deadline dates can be found on
the IRB website at www.unmc.edu/irb.
B. Expedited Review 
Applications that qualify for expedited review have no submission deadline and can be
reviewed independent of the IRB meeting schedule. Call the Office of Regulatory
Affairs for assistance in determining if your study meets the requirements for
expedited review.
ADDITIONAL REVIEW REQUIREMENTS
Final IRB approval and release of studies is contingent upon approval by the
following UNMC committees or departments. Check the appropriate boxes: 
UNMC and NM - Pharmacy & Therapeutics (P&T) Committee (Required for studies
involving drugs) 
Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC) (Required for
studies involving cancer) 
Institutional Biosafety Committee (IBC) (Required for studies involving the use of gene
transfer and vaccines) 
Investigational Device Review Committee (IDRC) Review by the IDRC is required for all
protocols involving the use of investigational or marketed devices 
Billing Grid (Required for all studies involving billing for hospital/clinic services) 
Coverage Analysis (Departments requiring this analysis have been specified by the
Organization) 
Conflict of Interest (COI) Management Plan (Required for all studies with declared COI by
study personnel) 
♦ Sponsored Programs Administration (SPA)/UNeHealth grants and contracts
Pathology approval for collection of tissue samples required for this study 
Radiation Committee Approval 
Other Review 
None of the above organizational requirements apply to this study 
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SECTION IV
COVID-19
1. Written documentation 
List all of the location(s) that will be used for informed consent, visits, or other
procedures. Provide the name and title of the person(s) granting permission AND
written documentation that the researchers have permission to conduct the study in all
location(s) proposed.
Locations:
Central District Health Department (CDHD),
Community Action Partnership of Western Nebraska (CAPWN),
East Central District Health Department (ECDHD),
Two Rivers Public Health Department (TRPHD)
Please see Letters of Support uploaded from Teresa Anderson (Director, CDHD), Betsy
Vidlak (Director, CAPWN), Charles Sepers (Chief Officer, ECDHD), Jeremy Eschliman
(Director, TRPHD).
2. Describe mask, visitor, and other guidance or policies required by each site. 
Please see our COVID protocol for conducting any contacts (uploaded). Our procol is based
on the guidance from the CDC if you will be in close contact with or are conducting home
visits and at the beginning of the study this protocol will be updated and revised (and in an
ongoing basis as necessary) by the Community Work Group (CWWG) that includes
directors and providers from local Health Departments and oversee the community
strategies in this study.
Multiple areas of the state are experiencing community spread of the virus that causes
COVID-19, but different parts of Nebraska are impacted differently. As different areas of the
state experience hot spots or other unique risk factors, stricter guidelines may be needed to
help minimize the spread of disease and protect the health of people residing and working in
these areas. As in this study we will be working closely with the Nebraska Health
Department (DHHS) as member of our CWG we will always follow their currently guidelines
and the state directives
(http://dhhs.ne.gov/Pages/COVID-19-Directed-Health-Measures.aspx).
3. Describe the source of PPE. 
The study via it's funding will provide all necessary PPE (e.g. masks, eye protection, gowns
and gloves) and any supplies necessary (e.g. hand sanitizer, wipes, infrared digital
thermometer) for conducting this study and help minimize the spread of disease and protect
the health of people residing and working in these areas.
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4. Describe other plans to be instituted by investigators enhance safety of
subjects, such as social distancing, remote visits, flexible scheduling, etc. 
The possibility of of COVID-19 transmission highlight the importance and contributions of
our study like ours that aims to develop and test a technology-based interventions do not
require in-person sessions. Aligning with the importance of prioritizing public health activities
while maintaining social distancing to reduce exposure to and transmission of COVID-19,
and limiting in-person care. At the same time, it brings challenges of managing study related
activities such as the anthropometric assessments.
This will require a multipronged and phased approaches and strategies for Face-to-Face
Activities and following our community-based participatory research approach, this will be
done together with our Community Working Group (CWG). We will expand in our proposed
COVID protocol (uploaded) that we have been using in previous studies and leverage local
accessible mobile technologies, evidence-based and culturally relevant approaches tailored
for each community and area of this study.
Including explore telemedicine and other ways to use new technologies that may facilitate
evaluation of intervention outcomes. As well, coordinate with partners to provide all
equipment necessary and rapidly deploy and restock PPE, including masks, gloves,
goggles, gowns, hand sanitizer, and cleaning supplies. Proactively planning and updating
protocols with contingency plans that could include altering procedures, cross-training staff,
and expand the using available technology to replace in person contacts such as RedCap
and Qualdrics. For example, for those having face-to-face interaction with participants
maybe a more comprehensive PPE may be indicated, depending upon the context,
prevalence of COVID-19 in the community, degree of contact with the client, and healthcare
activity pursued at their home or non-home residential settings.
This collaborative approach for development of study protocols and routines are aimed not
only for the participants safe completion of research activities but as well to assisting state
and local health departments to balance the competing demands of their COVID-19
response. Following and contributing to standardize and endorse readiness protocol for
CHWs responding to COVID-19. Furthermore, the majority of the contact with participants
and all the in-person assessments will be completed by CHWs. Their engagement in the
study will be assured via direct contract with the community partners as proposed by them
and agreed before the proposal and ensured necessary resources at the funding budget
(see letters of support). CHW are equipped, trained and supported as part of a well-
functioning health system. Existing CHWs are well trained to prevent, detect and respond to
COVID-19 as part of their regular work activities, including home visits for contact tracing,
isolation and quarantine follow-ups.
As basic principle for protocols designed to ensure the physical safety and health of
participants, follow DHHS and CDC guidance. For example, while performing any research
activity CHW, CWG and all research personnel will be required to wear facemasks to
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prevent transmission. They will be advised to check for any signs or symptoms of illness
before reporting to work and to notify their supervisor if they become ill. In addition, they will
be reminded to not report to work when they are ill. Investigators will follow recommended
work restrictions and monitoring based on staff exposure to patients with COVID-19. We are
implementing a process of screening staff and participants for fever or respiratory symptoms
before any in-person activities.
For qualitative data collection (focus group, interviews and Usability tests) if an appropriated
space to permit social distancing are not available locally (and if recommended and
approved by the CWG) we will deploy an alternative way to conduct live online data
collection. This alternate approach unlike in-person enable people to take part, without the
need to travel and expose to contact. We have budget for an IT analyst as part of the
research team to help with any technology challenges that may arise. However, the added
convenience of being able to participate from the comfort of your own home or place of your
choice means that online focus groups are also easier to recruit for and result in higher
response and engagement rates. Participants will be invited to log on to a live online
session at a specified time. We will use Zoom (via UNMC SSO) due it be one of the most
popular platforms to use due to its ease of use, and includes 256-bit GCM encryption which
provides even greater data safety and security, meaning that data will still be UNMC
security compliant. Sessions will be conducted by trained bilingual facilitators following the
same process proposed by the in-person method and the records and transcript will follow
the same security protocols (described in Sources of Materials section in Question 12-B).
5. Describe plans for site and/or equipment cleaning, and the source of
appropriate cleaning supplies. 
After each data collection staff will use of disinfectant wipes (for example, Clorox or alcohol
70% wipes) provided by study on all the equipment (scale, stadiometer) and devices (iPad)
and perform hand hygiene again.
Any disposable PPE used should be removed outside of the home and discarded by placing
in a plastic bag and into an external trash can before departing location. PPE should not be
taken from the home in personnels vehicle. Staff will carry a supply of plastic bags for
appropriated disposal of PPE.
Please see our COVID protocol for study assessment.
6. Describe when COVID-19 screening questions will be asked of each research
subject, and by whom. 
Screening questions for Community Health Worker (CHW) prior to assessment scheduling
and visits:
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1. Do you have a cough, fever, rash, runny nose, muscle aches or sore throat?
Yes ____ No_____
2. In the last month have you traveled to an area with a widespread outbreak, or had close
contact with a person known to have: Novel Coronavirus (COVID-19), MERs-CoV, or
Ebola?
Yes ____ No_____
3. Have you traveled outside of the country within the last month?
Yes ____ No_____
In addition, we will conduct a non-contact temperature checking using infrared digital
thermometer and report the result in the form. CDC lists fever as one criterion for screening
for COVID-19 and considers a person to have a fever if their temperature registers 100.4 or
higher -- meaning it would be almost 2 degrees above whats considered an average normal
temperature of 98.6 degrees.
Please see our COVID protocol for CHW - Appendix - Screening questions
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ADDENDUM B
Research Involving Pregnant Women, Fetuses and Neonates of Uncertain
Viability or Non-Viable
Title of Protocol
Family Connections: Cultural adaptation and feasibility testing of a technology-based
pediatric weight management intervention for rural Latino communities
Principal Investigator
Silva, Fabiana B - COPH Health Promotion - 402-559-6363 -
fabiana.silva@unmc.edu
1. Preclinical Studies and Studies on Non-Pregnant Women [45 CFR 46.204(A)] 
A. Will Pregnant women/fetuses be included in the research?
No
6. Research Involving Neonates of Uncertain Viability [45 CFR 46.205] 
A. Will the research involve neonates of uncertain viability?
No
7. Research Involvng Nonviable Neonates [45 CFR 46.205(c)] 
A. Will the research involve nonviable neonates?
No
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