Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents
Phase: NA
Conditions: Obesity, Activity, Motor, Diet, Healthy, Sedentary Behavior
Sponsor: University of Miami

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1)
Protocol Title
St. George K01: Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents
2)
IRB Review History*
This study was approved on 6/14/2016.
3)
Objectives*
Because Hispanic adults and adolescents are most likely to access the internet from smartphones, an 
innovative way to package family-based interventions for Hispanic families may be through the use of web and 
mobile phone technology (eHealth). Previous eHealth interventions for improving adolescent physical activity, 
sedentary behavior, and diet show promise; however, these approaches have largely targeted individual 
adolescents only (e.g., through computer/ video games) with limited parental involvement. Integrating family-
related constructs, such as family functioning, more directly within eHealth interventions, particularly those 
targeting Hispanics, may thus improve their efficacy and effectiveness. As such, the specific aims of this study 
are:  
AIM 1: To conduct formative research which will inform the development of a family-based eHealth obesity 
prevention intervention for increasing moderate-to-vigorous physical activity, decreasing sedentary 
behavior, and improving quality dietary intake in Hispanic adolescents. 
To accomplish this aim, we will employ a user-centered design approach to integrate the perspectives of 
Hispanic parent-adolescent dyads during the intervention development process. Specifically, we will: 1a) 
conduct four focus groups and/or individual interviews with 20 Hispanic parents and adolescents to assess the 
needs and capabilities of the target audience; 1b) develop visual mockups of the intervention known as “paper 
prototypes” and iteratively revise and retest them through collecting usability and user feedback data from 
three groups of 5 Hispanic parent-adolescent dyads; 1c) develop a fully functional intervention prototype; and 
1d) conduct a field trial with 10 Hispanic parent-adolescent dyads using the fully functional eHealth 
intervention prototype to refine intervention content and usability accordingly.
AIM 2: To conduct a pilot randomized trial to determine the feasibility, acceptability, and preliminary effects 
of a family-based eHealth obesity prevention intervention for increasing moderate-to-vigorous physical 
activity, decreasing sedentary behavior, and improving quality dietary intake in Hispanic adolescents. 
To accomplish this aim, we will: 2a) recruit 50 parent-adolescent dyads; and 2b) randomize dyads to a family-
based eHealth intervention or digital standard of care. It is hypothesized that the experimental intervention 
will be feasible, acceptable, and show promising effects vs. digital standard of care in increasing moderate-to-
vigorous physical activity, decreasing sedentary behavior, and improving quality dietary intake in adolescents 
at post intervention and a 6 month follow-up. Changes in parent physical activity, sedentary behavior, and diet 
will be assessed as secondary outcomes and changes in family functioning will be examined as a potential 
mediator of the effect of condition on outcomes. 
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4)
Background*
Obesity is the most prevalent risk factor for cardiovascular disease (CVD) among adolescents, with 34.5% of 
12-19 year olds currently overweight or obese. These rates are disproportionately higher in ethnic minority 
adolescents, including Hispanics, 38% of whom are overweight or obese compared to 31% of non-Hispanic 
Whites. Although engaging in physical activity and healthy dietary behaviors in adolescence reduces CVD risk, 
only 26% of Hispanic adolescents are physically active for 60 minutes/day and nearly 40% watch ≥3 hours/day 
of television. The diets of Hispanic adolescents have also been shown to contain high levels of fat and added 
sugar, and low levels of fruits and vegetables. Effective preventive interventions are thus urgently needed to 
promote healthy lifestyle behaviors in this population.
Ecological models of pediatric obesity consistently underscore the important role of the family system, which 
may serve to offset risks in other domains. In fact, meta-analyses of pediatric obesity interventions often 
conclude that family-based programs, or those that involve parents, are among the most efficacious. Family-
based interventions may be especially relevant for Hispanics due to familismo, or a strong commitment to the 
family system. Despite the relevance of the family for Hispanics, however, there is surprisingly little research 
examining the effects of family-based obesity prevention programs in Hispanic adolescents.
An innovative way to package family-based obesity prevention interventions for Hispanic families may be 
through the use of web and mobile phone technology. Technology use has become pervasive, with data from 
nationally representative surveys indicating 84% of adults and 95% of adolescents access the internet. 
Surprisingly, Hispanics (76%) are more likely than non-Hispanic White internet users (60%) to access the 
internet from a mobile device. The use of eHealth interventions thus presents a highly promising and viable 
option for delivering family-based obesity prevention interventions to Hispanic parents and adolescents.
Systematic reviews of eHealth interventions for adolescent physical activity, sedentary behavior, and dietary 
change published in the last five years suggest they are feasible, acceptable, and demonstrate some 
improvements in healthy lifestyle behaviors. These interventions, however, have been largely targeted 
towards individual adolescents (e.g., through computer/video games) with limited or no parental involvement, 
which may account for their generally small and/or lack of sustained effects. When parental involvement has 
been integrated, it has generally included health education only (e.g., healthy recipes). One exception is a 
recent web-based intervention for mother-daughter dyads living in public housing which targeted 
improvements in family communication and demonstrated significant improvements in girls’ fruit intake and 
mothers’ physical activity and vegetable intake. To date, only two other adolescent obesity-related 
interventions have targeted improvements in family processes such as positive parenting using an eHealth 
approach; both of these, however, were treatment (not prevention) studies for African American adolescents. 
Integrating family functioning more directly within eHealth interventions, particularly those targeting 
Hispanics, may enhance their efficacy and effectiveness, but more research is needed.
In summary, given the dearth of research on family-based approaches for obesity prevention in Hispanic 
adolescents, this study will provide novel and significant information regarding the development and 
preliminary effects of a family-based eHealth obesity prevention intervention that integrates web and mobile 
phone technology. 
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5)
Inclusion and Exclusion Criteria*
This project has two research aims and will be conducted across four phases. Aim 1 employs a user-
centered design approach to elicit feedback from members of the target population throughout the 
intervention development process across three phases: focus groups and/or individual interviews, 
testing of paper prototypes, and a field trial. Aim 2 (the fourth and final phase) is a pilot randomized 
trial of a family-based eHealth obesity prevention intervention. All inclusion and exclusion criteria 
listed below (with the exception of exclusion criteria “e,” applied to Aim 2 participants only), will apply 
to all study participants: 
Inclusion criteria: 
(a) Female and male adolescents whose primary caregiver self-identifies as Hispanic  
(b) Adolescent is between the ages of 12-15; 
(c) Adolescent lives with an adult primary caregiver willing to participate; 
(d) Both parent and adolescent own a smartphone with internet access; 
(e) Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet 
quality) as determined by a validated two-item screener; 
(f) Adolescent does not meet physical activity guidelines as determined by responses on a validated two-
item screener AND self-reports engaging in >2 hours/day of screen time (proxy for overall sedentary 
behavior) using three items. 
Exclusion criteria: 
(a) Adolescent’s body mass index for age and gender is ≥ 95th percentile (“obese” range);
(b) Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle 
modification; 
(c) Adolescent has a diagnosed developmental delay that would interfere with understanding program 
materials; 
(d) Parent or adolescent has a diagnosed medical or psychiatric condition and is currently taking 
medications that would interfere with changes to physical activity or diet (e.g., adolescent is 
diagnosed with Attention Deficit Hyperactivity Disorder and is currently on stimulant 
medication); 
(e) Family is planning to move out of the South Florida during the study follow-up period
6)
Number of Subjects*
A total of 95 Hispanic adolescent-primary caregiver dyads (“families”) will participate throughout the 
duration of the study, conducted across four total phases. The breakdown of participants by research 
aim and study phase is detailed below: 

Aim 1, Phase 1: Focus groups and/or individual interviews (n = 20 families)

Aim 1, Phase 2: Testing of paper prototypes (n = 15 families)

Aim 1, Phase 3: Field trial (n = 10 families)

Aim 2: Pilot randomized trial (n = 50 families)
7)
Study-Wide Recruitment Methods*
Participants will be recruited from local pediatric primary care clinics in South Florida, including the following: 
UHealth Pediatrics at the Professional Arts Center, University of Miami Pediatric Mobile Clinic, UHealth at 
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Kendall, Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital, Kidstown Pediatrics, South 
Florida Pediatric Partners, Borinquen Medical Centers, Primecare Family Centers, ECC Pediatrics, Dr. Ileana 
Fuentes Clinic,  Castro Pediatrics, Gables Pediatrics, Belkys Bravo Pediatrics, Pediatrics & Family Medicine 
Associates, Dr. Rene Lopez-Guerrero Clinic, Dr. DeChurch Clinic, and Francisco E. Martinez Clinic.
Hispanic families who participated in previous University of Miami studies AND agreed to be contacted for 
future studies will additionally be invited to participate in the current study. Only staff members approved on 
both study protocols will contact these participants by phone to invite them to learn more about the current 
study. In the case of previous University of Miami studies already closed on eProst (to which we cannot add 
our staff members), we will list their eProst protocol numbers here: 20180944. 
We will also obtain a list of potentially eligible participants from the UM Consent to Contact Database. The 
following criteria (or similar) will be used to generate the patient contact list: Healthy volunteers, Hispanic, 
Parent of a young teen (12-15 years of age). After receiving the lists of potentially eligible participants, study 
staff will contact individuals via phone using the Consent to Contact Script. 
We will additionally recruit families through word-of-mouth, referrals from families who participated in 
previous phases of the study, and through posting ads on social media (e.g., Facebook, Instagram) and flyers 
(See “Healthy Juntos Flyer”) in various locations throughout the community (See “Media Tool Kit: Brochure, 
Flyer and Palm card”). For those who learn of the study via social media, they will first be asked to provide 
their electronic consent to a brief online eligibility pre-screener (See “Online Eligibility Pre-Screener”). Once 
consent has been provided, individuals will be directed to the pre-screener in the project’s landing page, the 
responses to which will be captured in REDCap. Study staff will review all completed online pre-screeners and 
determine whether respondents appear to meet preliminary eligibility criteria. Study staff will call the 
respondents who meet the preliminary criteria to complete the screening process. Participating families will 
be encouraged to have interested friends contact the study team and will be compensated $10 for every 
referral of a potentially eligible family received.
Recruitment will occur over a four year period and will include multiple waves corresponding to each of four 
phases of the study: focus groups and/or individual interviews (n=20), testing of paper prototypes (n=15), field 
trial (n=10), and pilot randomized trial (n=50). 
To recruit families from the pediatric primary care clinics, a point person from each clinic will work with study 
staff members to identify Hispanic adolescents (and their caregivers) scheduled for a doctor’s visit. The clinic 
staff will inform study staff at least one day in advance whether a Hispanic adolescent between the ages of 12 
and 15 is scheduled to visit the clinic. During the family’s medical appointment, providers will ask the family 
whether they are interested in learning more about a study to improve healthy lifestyle behaviors, including 
physical activity and nutrition among Hispanic adolescents. If the family is interested, they will be instructed to 
contact the study team or provide their verbal consent to be contacted by the study team for screening. 
Families who meet the inclusion/exclusion criteria and are interested in participating will be given a detailed 
description of the study by study staff members. Prior to data collection, participants will complete an 
informed assent form (adolescents) and an informed consent form (caregivers) either in-person or remotely. 
To avoid coercion of the adolescent by the parent, we will ask parents give the adolescent privacy. In case the 
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adolescent does not want to sign, the family will be told they did not meet one or more of the 
inclusion/exclusion criteria but the study staff member will not reveal to the parent that the adolescent did 
not want to participate (to avoid any consequences to the adolescent). 
Participants will be compensated as follows during each of the study phases: 
Study Phase
Parent Compensation
Adolescent Compensation
Aim 1, Phase 1: Focus groups and/or 
individual interviews
$50
Two movie tickets
Aim 1, Phase 2: Testing of paper prototype
$60
Three movie tickets
Aim 1, Phase 3: Field trial
Weekly $5 digital gift card 
contingent on both parent 
and adolescent completion 
of weekly survey
$40 digital gift card for final 
interview
Keep their wrist-worn 
activity tracker 
$30 digital gift card for 
final interview
Keep their wrist-worn 
activity tracker 
Aim 2: Pilot randomized trial
Digital gift cards in the 
following amounts: T1 = 
$60; T2 = $65
$40 digital gift card for final 
interview
Keep their wrist-worn 
activity tracker
Digital gift cards in the 
following amounts: T1 = 
$20; T2 = $20
$30 digital gift card for 
final interview
Keep their wrist-worn 
activity tracker
8)
Study Timelines*
The duration of each family’s participation in the study is contingent on the study phase to which they 
are recruited to participate. Details are below: 

Aim 1, Phase 1: Focus groups and/or individual interviews (n = 20 families will be recruited to 
participate in a single 1-2 hour session)

Aim 1, Phase 2: Testing of paper prototypes (n = 15 families will be recruited to participate in a 
single 1-2 hour session)

Aim 1, Phase 3: Field trial (n = 10 families will be recruited to participate in an 8-week eHealth 
intervention program. In addition to completing eight weekly eHealth sessions (each lasting 45 
minutes) from their own smartphones or computers, families will complete brief weekly 
electronic surveys to provide their feedback on the eHealth intervention)

Aim 2: Pilot randomized trial (n = 50 families will be recruited to participate in measures at two 
time points: baseline, and 2-months post baseline. Each measurement session is anticipated to 
last two and a half hours. Families randomized to the eHealth intervention condition will 
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additionally complete eight weekly eHealth sessions (each lasting 45 minutes) from their own 
smartphones or computers. 
The overall study (including all four phases described above) will be completed by October 2022.
9)
Study Endpoints*

Aim 1, Phase 1- Aim 1, Phase 3: Qualitative feedback from participants at different stages in the 
intervention development process to inform ongoing intervention design

Aim 2, Phase 4: 
-
Primary: Changes in adolescent moderate-to-vigorous physical activity, sedentary behavior, and 
quality dietary intake
-
Secondary: Changes in parent moderate-to-vigorous physical activity, sedentary behavior, and 
quality dietary intake; family functioning examined as a potential mediator of the effect of 
condition on outcomes 
10) Procedures Involved*
Aim 1 of this study employs a user-centered design approach to elicit feedback from members of the target 
population at various stages throughout the intervention development process. We will work with 
technologists from a technology research center to create visual mockups, known as “paper prototypes,” and 
a fully functional intervention prototype. We will employ a user-centered design approach, or an iterative 
process whereby an understanding of the needs and preferences of end users is obtained to inform 
intervention content and usability. The user-centered design process in this study will include focus groups 
and/or individual interviews, development and testing of initial paper prototypes to create a fully functional 
prototype, and a field trial for testing the fully functional prototype. Procedures for each of these phases of 
the user-centered design approach are detailed below: 
Aim 1, Phase 1: Focus Groups and/or individual interviews. We will first conduct four focus groups (2 
parent-only and 2 adolescent-only groups; 10 individuals/group) and/or a series of individual 
interviews to inform intervention content and technical development. Prior to focus group and/or 
individual interview sessions, participants will complete brief questionnaires including demographic 
items and items about their technology use. Participants will also have their height and weight 
measured by study staff (or by a medical provider at their primary care clinic). Height will be measured 
using a stadiometer. Weight will be measured using a digital scale.
During focus group and/or individual interview sessions, parents and adolescents will be asked a series 
of questions designed to understand how they currently use technology for their health, how they 
define a healthy lifestyle, how they participate in healthy lifestyle activities with their families, and 
what they think of the research team’s ideas to develop an eHealth intervention (see “Focus 
Group/Interview Question Guide”). Focus groups and/or individual interviews will be guided by 
previously established methods for conducting focus groups and/or individual interviews with 
Hispanics (e.g., bilingual facilitator), will be conducted at either the researchers’ office, an office in one 
of the primary care clinics, the participants’ home, by phone, or by videoconference, will last 1-2 hours, 
and will be audio-recorded and then transcribed by study team members or the National Captioning 
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Institute, a professional transcription agency. Results will be used to create visual mockups, or “paper 
prototypes” of the eHealth intervention. 
 
Aim 1, Phase 2: Testing of Paper Prototypes: We will then iteratively collect usability and user 
feedback data from parent-adolescent dyads. Prior to formal consenting/assenting procedures, 
parents and adolescents will provide verbal consent to have the adolescents’ height and weight 
measured by study staff to confirm their eligibility for this phase of the study. Height will be measured 
using a stadiometer. Weight will be measured using a digital scale. Once participants formally consent 
for the study, parents will also have their height and weight measured and recorded. Parents and 
adolescents (separately) will then be shown paper and minimally-functioning versions of the 
intervention and asked to interact with them by pointing to features/links they might select. As they 
interact with the prototypes, they will be presented with the next “screen” and asked to “think aloud” 
as they make their selections (see “Paper Prototype Interview Guide”). The “think aloud” method is 
used to understand participants’ navigation of websites, identify problems early in the design process, 
and develop suggestions for improvement. They will additionally be asked general questions related to 
what they liked most/least about the prototypes, how they might be improved, and how likely they 
would be to use a website that looked like the prototypes.  Finally, participants will complete a brief 
demographic survey and a measure of the prototype’s usefulness and ease of use (see “USE 
Questionnaire”). The entire session will be conducted at either the researchers’ office, an office in one 
of the primary care clinics, the participants’ home, or a location of the participants’ choosing that 
offers privacy (e.g., a private room at the participants’ local library) will last 1-2 hours and will be 
audio-recorded and transcribed by study team members or the National Captioning Institute. Potential 
flaws to the eHealth intervention will be identified and corrected as participants provide feedback. 
Data gathered during paper prototype testing will then be used to create a fully functional intervention 
prototype. 
Aim 1, Phase 3 Field trial:  During the final phase of formative testing, we will conduct a field trial using 
the fully functional eHealth intervention prototype. Field trials involve the collection of data in users’ 
natural environments and can evaluate technology for flaws that will only emerge through use over 
time. Participants will be instructed to wear a physical activity monitor and interact with the 
intervention using their own smartphones and/or computers over the course of eight weeks. 
Prior to formal consenting/assenting procedures, parents and adolescents will provide their height and 
weight. Following the informed consent/assent process, participants will be asked to complete a brief 
demographic survey. Study team members will then provide an overview of smartphone security 
education to each participant (see “Smartphone Security Tips Checklist”), show participants how to log 
in to and use the program, and review the intervention terms of service and privacy policy following 
log-in.
At the end of each week, participants will be asked to complete a brief electronic survey that asks them 
to rate weekly content, including what they liked/disliked and would change about each session (see 
“Field Trial Weekly Questions”). At the end of the eight weeks, participants will be asked to complete a 
brief survey and a final interview to discuss their overall experience using the entire program (see “USE 
questionnaire and “Field Trial Final Interview Question Guide”). The final interview session will be 
conducted by phone or videoconference, will last 1–2 hours, and will be video or audio-recorded and 
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then transcribed by study team members or the National Captioning Institute. Refinements will be 
made to the eHealth intervention prior to the pilot study.
Aim 2 is a pilot randomized trial of the family-based eHealth obesity prevention intervention. The pilot study 
will use a mixed design with two levels of intervention (family-based eHealth intervention and digital standard 
of care comparison) as the between subjects factor and two repeated measures (T1=baseline, T2=post-
intervention) as the within-subjects factor. To confirm adolescent’s eligibility for this phase of the study, 
parents and adolescents will provide verbal consent to have the adolescents’ height and weight measured by 
study staff. Once participants formally consent for the study, parents will also have their height and weight 
measured and recorded. During each time point, the following measures will be collected from both parents 
and adolescents. Participants will complete questionnaires using their own smartphones or desktop 
computers.
Body Measures:  Height will be measured using a stadiometer. Weight will be measured using a digital 
scale or a bioimpedance scale. Waist circumference will be measured using a tape measure. Body 
composition will be obtained with a bioimpedance scale. Each measurement will be taken at least 
twice. 
Lifestyle Behaviors (for eHealth intervention condition ONLY):  Daily steps and dietary intake will be 
measured using a wrist-worn device. Participants will wear the monitor all day and night for the first 
two months, only removing it to shower and do other activities, such as swimming, where the monitor 
would be underwater. Participants may receive phone calls to check on compliance with wearing the 
monitor (see “Instructions for Physical Activity Monitor”).
Questionnaires: Parents and adolescents will complete self-reported questionnaires that assess 
constructs including demographics, physical activity, dietary intake, parenting practices, family 
relations, parent-adolescent communication, acculturation, and motivation (see “Parent Measures 
Packet” and “Adolescent Measures Packet”).
Once families complete the baseline assessment, they will be randomized (1:1) into one of two possible study 
groups, eHealth Intervention or digital standard of care. Participants will be informed of their group 
assignment by phone. 
eHealth Intervention Group: Participating parents and adolescents will receive a wrist-worn physical activity 
tracker (Fitbit). Study team members will provide an overview of smartphone security education to each 
participant (see “Smartphone Security Tips Checklist”), show participants how to log in to and use the 
program, and review the intervention terms of service and privacy policy following log-in.
 
Families randomized to the eHealth intervention will be log in to a secured website for approximately 45 
minutes each week for a total of eight weeks. The eHealth intervention will be delivered primarily through 
smartphones but will be developed using a responsive web design, or one that “responds” to the users’ device 
(e.g., smartphone, computer) by automatically adjusting the viewing experience (e.g., image resolution, size). 
This design will provide participants with flexibility in engaging with intervention content. 
The website will include didactic content on healthy lifestyle behaviors (for parents/adolescents), a family 
behavior change tool for setting weekly goals (for parents/adolescents), and a positive parenting tool (for 
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parents only), all of which will be developed in accordance with participant feedback from the formative 
development stage of the study (Aim 1).  A HIPAA-compliant secure server architecture will be developed in 
support of the program described above. This will consist of an industry-standard Ubuntu Linux server using 
Ruby on Rails application software.
In addition, and to increase participant compliance/reduce attrition often observed in eHealth interventions, 
human support (“supportive accountability”) will be provided weekly. Each family will be assigned a “coach” 
who will use video conferencing software or phone to engage in a 15-30 minute conversation regarding their 
family’s progress. Sessions may be recorded for the purposes of training and supervision. No recording will be 
done without participant’s prior knowledge and consent.
At the end of each week, participants will be asked to complete a brief electronic survey that asks them to rate 
weekly content, including what they liked/disliked and would change about each session (see “Pilot Study 
Weekly Questions”). At the end of the eight weeks, participants will be asked to complete a brief electronic 
survey (see “USE questionnaire”). In addition, a randomly-selected subset of participants (n=12-15) assigned 
to the intervention condition will be asked to complete a final interview to discuss their overall experience 
using the entire program (see “Pilot Study Final Interview Question Guide”). The final interview session will 
be conducted by phone or videoconference, will last 1–2 hours, and will be video or audio-recorded and then 
transcribed by study team members or the National Captioning Institute. 
Digital Standard of Care Group: Families randomized to digital standard of care will receive a list of 
free health apps and publicly available health websites (see “Digital Health Resource List”). Study team 
will contact them when it is time for the scheduled measures. In addition to the standard measures, 
participants will be asked to complete a brief electronic survey about their experience using the listed 
apps and websites at 2 months and 8 months post baseline (see “Digital Standard of Care Survey”).   
11) Data and Specimen Banking*
NA – no specimens will be collected.
12) Data Management*
Aim 1 of this study employs a user-centered design approach to elicit feedback from members of the 
target population at various stages throughout the intervention development process. All qualitative 
data gathered throughout this process (focus groups and/or individual interviews, testing of paper 
prototypes, field trial) will be transcribed by study team members or the National Captioning Institute. 
Once transcripts are completed, data will be analyzed using a rapid assessment and/or general 
inductive approach to derive themes. A general inductive approach is a systematic procedure that 
entails multiple readings and interpretations of transcripts reflective of participant responses. Although 
findings are influenced by the evaluation objectives, findings will be derived directly from the raw data 
(i.e., participants’ comments). Study staff members will read all transcripts in detail and will iteratively 
develop a comprehensive code book outlining all category labels and descriptions. The code book, 
along with predefined decision rules, will guide the process of coding. A qualitative software program 
will be used to perform a content analysis.
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Descriptive statistics (e.g., means, standard deviations) will be used to summarize quantitative data 
gathered from the USE Questionnaire during this phase. 
Aim 2 is a pilot randomized trial of the family-based eHealth obesity prevention intervention. Because this is a 
pilot study, sample size was not determined through traditional power analyses but by using the guide of 15 to 
30 participants per condition. Given the small sample size (n = 50), we will first examine descriptive statistics 
over time by condition. Trajectories of outcomes by condition will be plotted to visualize potential 
intervention effects (i.e., differences in trajectories by condition). Percentages of outcome changes by 
condition from baseline to 8 weeks follow-up will also be calculated to show intervention effects. To test the 
hypothesis that the intervention will show promising effects compared to digital standard of care in increasing 
moderate-to-vigorous physical activity, reducing sedentary behavior, and improving quality dietary intake in 
adolescents at post intervention, we will run latent growth models for each of the three primary outcomes of 
interest. Power for latent growth models is often much greater than that of repeated ANOVA methods 
because the unit of analysis is the slope of the trajectory, and I have two time points. In estimating these 
models, we will focus on effect size estimates as opposed to statistical significance. Latent growth modeling 
analyses will test differences in trajectories of outcomes over the two time points across the two conditions. 
Effect sizes will be calculated as the ratio of the difference in the slope between conditions divided by the 
standard deviation of the slope growth factor. After conducting the latent growth analysis, the model-
estimated outcomes will also be plotted (by condition) to visualize trajectories over time by condition. This 
same procedure will be used to examine secondary parent outcomes. Finally, exploratory mediation analyses 
will be conducted using the "product of coefficients" test to examine whether the effects of condition on the 
outcomes will be partially mediated by changes in family functioning.
13) Provisions to Monitor the Data to Ensure the Safety of Subjects*
We do not expect for this study to create more than minimal risk for participating families; however, 
the study will be monitored for safety by the study investigators.
14) Withdrawal of Subjects*
Families will be informed that their participation in the study is completely voluntary and that they have the 
right to withdraw at any time without any negative consequences. 
Circumstances under which participants will be withdrawn from the study include: the parent or adolescent is 
arrested, reports suicidal ideation, or experiences some other extreme adverse event. If a participant is 
arrested, reports suicidal ideation, or some other extreme adverse event, a qualified study staff member (i.e., 
Dr. Sara St. George, a licensed psychologist) may ask them to withdraw from the study, and if appropriate, 
refer them to necessary services. According to IRB, if a participant becomes incarcerated while enrolled in a 
study, all research interactions and interventions with that participant, and the obtaining of identifiable 
private information about the participant must cease. 
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15) Risks to Subjects*
Potential risks to participants are described below by study aim: 
Aim 1 of this study employs a user-centered design approach to elicit feedback from members of the target 
population at various stages throughout the intervention development process.

Participation in qualitative data collection (through focus groups and interviews): There is the 
potential for participants to be bothered by the questions asked during focus groups or individual 
interviews, which may make them feel uncomfortable, angry, sad, or embarrassed. Participants might 
also feel fatigued after focus group or individual interview sessions.

Body Measures (for Aim 1, Phases 1 and 2 ONLY): Participants will have their height and weight 
measured. Some concerns have been raised regarding potential adverse effects of anthropometric 
measurements used to assess body composition and categorize weight status. However, in 2010, the 
U.S. Preventive Services Task Force (USPSTF) reiterated their earlier statement (2005) that no direct 
evidence supports potential harms such as poorer self-concept, eating disorder pathology, or mental 
health problems, and that these were not incurred by standard obesity screening procedures used with 
children and adolescents (USPSTF, 2010; Whitlock et al., 2005). There is the potential risk of 
embarrassment for girls undergoing anthropomorphic assessments; however, care will be taken to 
conduct this examination in private and to minimize discomfort.  

Questionnaires: Participants will complete self-reported questionnaires. No side effects have been 
noted in the current literature in association with the self-reported assessments used in this study, 
although, as with many assessment batteries, some people may experience mild fatigue or momentary 
concern about their ability to perform well. Some participants may also feel embarrassed and/or 
bothered by some of the questions asked.
Aim 2 is a pilot randomized trial of the family-based eHealth obesity prevention intervention. 

Randomization to the eHealth intervention condition: There may be some discomfort from increasing 
physical activity levels or changing eating behaviors as a result of participation in the eHealth 
intervention condition.  The possibilities include, but are not limited to some muscle and joint stiffness. 
This stiffness generally subsides in 1 or 2 days, and is not considered to be serious.  

Body Measures: Participants will have their height, weight, waist circumference, and body composition 
measured. See potential risks for body measures listed under Aim 1 above. 

Lifestyle Behaviors Measures: Participants will wear physical activity bands to monitor their physical 
activity levels. There is no known risk of injury associated with wearing the activity bands in this study. 
The bands are worn around the wrist like many commercially available bands, are small and 
unobtrusive, and should cause no discomfort.  Participants will be monitored to determine if they are 
experiencing discomfort due to wearing the devices. 

Questionnaires: See potential risks for questionnaires listed under Aim 1 above. 
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16) Potential Benefits to Subjects*
There is no direct tangible benefit, other than the monetary incentive for participants involved in the focus 
groups and/or individual interviews and testing of paper prototypes. The most important benefit from 
participation in the field trial and pilot study is that adolescents may reduce their risk for obesity and both 
adolescents and parents may improve their physical activity, sedentary behavior, and diet. Additionally, 
families may benefit through improvements in communication and family functioning. 
17) Vulnerable Populations*
The research involves youth under the age of 18. To avoid coercion or undue influence, adolescents will assent 
and complete study measures separately from their primary care giver(s). In case the adolescent refuses to 
assent, the family will be told they did not meet one or more of the inclusion/exclusion criteria; to avoid any 
consequences to the adolescent, study staff will not reveal to the parent that the adolescent did not assent.
18) Multi-Site Research*
NA – this study is not a multi-site study 
19) Community-Based Participatory Research*
NA – this study is not considered community-based participatory research 
20) Sharing of Results with Subjects*
NA – results of this study will not be shared with participants 
21) Setting
The research team will identify and recruit potential participants from two pediatric primary care clinics 
affiliated with the University of Miami Health System, Jackson Memorial Hospital, and a private pediatric 
primary care clinic in the community. The first is a mobile clinic that travels to underserved areas in South 
Florida to provide free medical care to underinsured, predominantly ethnic minority youth. The second clinic is 
located within Jackson Memorial Hospital, South Florida’s only public health hospital, and serves mostly ethnic 
minority youth. The third clinic is located on the University of Miami Miller School of Medicine campus. The 
fourth is a private practice in the community. All recruitment and consent/assent activities as well as data 
collection will occur either in-person or remotely (by phone or videoconference).
For Aim 2, all data collection at T1, T2, and T3 will occur at either the researchers’ office, an office in one of 
the primary care clinics, the participants’ home, or a location of the participants’ choosing that offers privacy 
(e.g., a private room at the participants’ local library). The intervention will be delivered online; thus, 
participants will most likely be in their homes or places with Internet access (e.g., school, library) to receive 
the intervention. 
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22) Resources Available
Investigative Team: 

Dr. Guillermo Prado is Miller Professor of Public Health Sciences, Director of the Division of Prevention 
Science and Community Health in the Department of Public Health Sciences at the University of Miami 
Miller School of Medicine, and Dean of the Graduate School at the University of Miami. Dr. Prado, a 
trained epidemiologist, has been conducting research with Hispanic families for 15 years and has 
substantial experience coordinating and managing the research activities of major longitudinal randomized 
clinical trials including recruitment, data collection, quality control, data analysis, and dissemination of 
study findings. Throughout his career, Prado has received over $75 million dollars of extramural funding as 
either PI, Co-I, or mentor and has published over 100 peer-reviewed papers. He co-developed Familias 
Unidas, a Hispanic-specific family-based preventive intervention found to be efficacious and effective in 
preventing and reducing substance use and sexual risk behaviors across four NIH-funded R01 randomized 
controlled trials. Related to the current study, Dr. Prado’s most recently funded R01 trial is examining the 
efficacy of an adapted version of Familias Unidas for increasing physical activity and healthy dietary intake 
in Hispanic adolescents. 

Dr. Sara M. St. George is an Assistant Professor in the Division of Prevention Science and Community 
Health in the Department of Public Health Sciences at the University of Miami Miller School of Medicine. 
She has begun to establish herself as a pediatric obesity prevention scientist. Her research focuses on 
developing and evaluating theoretically-based interventions for ethnic minority adolescents which 
integrate multiple influential social systems (e.g., family, peers) to improve adolescent physical activity, 
sedentary behavior, and dietary intake patterns. She has developed the beginnings of an independent 
program of research in pediatric obesity prevention funded by a diversity supplement, pre-doctoral 
fellowship, and research award from the American Psychological Association’s Division 38 (Health 
Psychology). She has held leadership roles, such as Intervention Coordinator, on four randomized 
controlled efficacy trials aimed at promoting positive health behaviors in ethnic minority adolescents and 
adults using family-, school-, and community-based approaches. She has also been actively involved in the 
dissemination of important research findings and has contributed to 26 peer-reviewed publications, 3 
book chapters or encyclopedia entries, and over 50 conference presentations. Dr. St. George will be 
responsible for managing all aspects of the present study with supervision from Dr. Prado. 

Other study staff, including assessors, research assistants, and students, will be trained in study 
operating procedures, including screening potential study participants, consent/assent, and 
conducting assessments. Study staff members will be responsible for scheduling assessments and 
for maintaining cordial contact with participants between assessment time points to maximize 
retention rates at assessments. All study staff members will be CITI trained and adequately 
informed about the protocol, research procedures, and their duties and functions. Trainings will be 
held to ensure all study staff members are adherent to the study procedures. Regular meetings will 
also be held to discuss study updates, issues or concerns. 
Other Resources: 
Participants will be recruited from the following pediatric primary care clinics: UHealth Pediatrics at the 
Professional Arts Center, University of Miami Pediatric Mobile Clinic, UHealth at Kendall, Ambulatory Care 
Center West Pediatrics at Jackson Memorial Hospital, Kidstown Pediatrics, South Florida Pediatric Partners, 
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Borinquen Medical Centers, Primecare Family Centers, ECC Pediatrics, Dr. Ileana Fuentes Clinic,  Castro 
Pediatrics, Gables Pediatrics, Belkys Bravo Pediatrics, Pediatrics & Family Medicine Associates, Dr. Rene Lopez-
Guerrero Clinic, Dr. DeChurch Clinic, and Francisco E. Martinez Clinic.
o
UHealth Pediatrics at the Professional Arts Center. The Department of Pediatrics at 
UHealth is nationally and internationally acclaimed for education, research, patient care, 
and biomedical innovation. Offering a variety of services from routine healthcare and 
immunizations to the treatment of severe and chronic illnesses, UHealth Pediatrics is 
integrated into a dynamic research environment where innovative and effective preventive 
and treatments services are delivered and under development. UHealth Pediatrics is 
affiliated with Holtz Children’s Hospital, one of the largest children’s hospitals in the 
southeast United States. With over 150 child health specialists honored as Best Doctors®, 
UHealth Pediatrics has more Best Doctors than any institution in South Florida. UHealth 
Pediatrics at the Professional Arts Center is one of 9 UHealth sites. The pediatrics offices at 
UHealth have 10 exam rooms, a small conference/meeting area, and a reception/waiting 
area.  UHealth Pediatrics at the Professional Arts Center is directed by Dr. Lourdes Forster. 
o
The University of Miami Pediatric Mobile Clinic. This clinic has provided medical care to 
uninsured children since 1992. Services provided include well-visits, sports physicals, 
immunizations, management of chronic conditions, urgent care, mental health, and social 
work. The clinic provides direct primary medical care for nearly 3,000 children a year who 
are without health insurance, access to medical providers and linking to specialists. 
Therefore, we do not anticipate any challenges in recruiting 95 youth between the ages of 
12-15 over the three year recruitment period. The clinic is a bus with medical supplies and 
three medical exam rooms. Staff members travel with the bus across a 50 mile radius to 
serve communities with the highest percentage of children living in poverty and/or likely to 
be uninsured. Specific communities that will continue to be served through this program 
include: Little Havana, Homestead, Florida City, Little Haiti/North Miami, Westchester, and 
North Dade. Most of the visited areas have a community center or school rooms that can be 
utilized for extra medical exam room space. Typically, each site can offer three rooms.
o
UHealth at Kendall. This clinic is a part of the University of Miami Health System. UHealth at 
Kendall has more than 60 physicians and serves children in the S. Florida area, including 
general pediatrics. 
o
The Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital. This clinic is 
located within the Jackson Memorial Health System. The Jackson Memorial Health System is 
governed by the Public Health Trust, a dedicated team of citizen volunteers acting on behalf 
of the Miami-Dade Board of County Commissioners. Jackson Health System consists of 
Jackson Memorial Hospital; multiple primary care and specialty care centers; a variety of 
school-based clinics serving elementary, middle and high schools; two long-term care 
nursing facilities; six Corrections Health Services clinics; a network of mental health 
facilities; Holtz Children’s Hospital; Jackson Rehabilitation Hospital; Jackson Behavioral 
Health Hospital; Jackson North Medical Center, and; Jackson South Community 
Hospital. Jackson Memorial Hospital is an accredited, non-profit, tertiary care hospital and 
the major teaching facility for the University of Miami Leonard M. Miller School of 
Medicine. With more than 1,550 licensed beds, Jackson Memorial Hospital is a referral 
center, a magnet for medical research, and home to Ryder Trauma Center - the only adult 
and pediatric Level 1 trauma center in Miami-Dade County. Ambulatory Care Center West 
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Pediatrics at Jackson Memorial Hospital provides patients with comprehensive care in a 
variety of services including pediatric primary care, gynecology and obstetrics. The pediatric 
practice serves over 7,000 children and youth a year.  The Ambulatory Care Center West has 
more than a dozen exam rooms for the pediatricians. Dr. Audrey Ofir is the Director of 
Ambulatory Pediatrics and has agreed to have the Ambulatory Care Center West Pediatrics 
at Jackson Memorial Hospital serve as a recruitment site for the proposed study.
o
Kidstown Pediatrics, LLC. Kidstown Pediatrics, LLC, is located in a residential area 10 
minutes outside of downtown Miami. It is housed in a multistory office building and has 
2,000 square feet available for office space. Kidstown is a private practice that provides 
comprehensive primary care services for children of all ages. Specific treatments offered 
include HPV vaccination, medical care for asthma, treatment for ADD/ADHD, and other 
vaccinations. Emergency services are available 24 hours a day, 7 days a week, but it is 
generally open from 8:30am to evening, Monday through Friday.  Dr. Margaret Okonkwo, a 
practicing and board certified pediatrician, is President of KidTown, LLC. Dr. Okonkwo has 
been in practice for more than 10 years and serves approximately 6,000 children and 
adolescents per year.
o
South Florida Pediatric Partners. South Florida Pediatric Partners is a private pediatric 
practice. One of their clinics is directed by Dr. Carol Da Costa, a solo practitioner who has 
been part of the community for the last 15 years. She provides comprehensive pediatric 
primary care services for children of all ages. Dr. Da Costa serves over 100 Hispanic families 
per week and provides routine well-child care (e.g., vaccinations) as well as treatment for a 
range of childhood illnesses and symptoms. The clinic is open Monday-Friday 9am-5:30pm 
and two Saturdays per month. Patients also have access to an after-hours emergency line.
o
Borinquen Medical Centers. The clinic started as a grass-roots community effort in an 
underserved part of Miami-Dade, but now has expanded and offers comprehensive primary 
health care, dental, and behavioral health care throughout the County. Borinquen’s patient 
population is about half Hispanic. There are 8 pediatricians in Borinquen. 
o
Primecare Family Centers. Primecare is private organization in South Florida with 10 
physicians, offering pediatrics and family and internal medicine.  
o
ECC Pediatris. This clinic is a private clinic that provides pediatric primary care services to 
children and adolescents in the Doral area.
o
Dr. Ileana Fuentes Clinic. This clinic is a small private clinic offering pediatric services to 
children and adolescents. 
o
Castro Pediatrics, LLC. Castro Pediatrics LLC. Castro Pediatrics, LLC, is a private clinic in 
Miami that offers health services to youth. 
o
Gables Pediatrics. Gables Pediatrics at the Shops of Merrick Park is a private clinic in Coral 
Gables offering health care services to youth.
o
Belkys Bravo Pediatrics. Belkys Bravo Pediatrics is a private clinic in the Miami area that 
offers health services to youth. 
o
Pediatrics and Family Medicine Associates. This clinic serves youth and families in the Doral 
and surrounding areas. 
o
Dr. Rene Lopez-Guerrero. Dr. Lopez-Guerrero’s Clinic is located in Miami and serves youth 
of all ages. 
o
Dr. DeChurch Clinic. This is a private clinic run by Dr. Stephanie DeChurch located in Miami 
serving youth. 
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o
Dr. Francisco E. Martinez Clinic. Dr. Martinez’s clinic serves pediatric patients in the S. 
Florida area. 
23) Prior Approvals
This study was approved on 6/14/2016.
24) Recruitment Methods
Participants will be recruited from either the University of Miami Pediatric Mobile Clinic, Ambulatory Care 
Center West Pediatrics at Jackson Memorial Hospital, UHealth Pediatrics at the Professional Arts Center, or Da 
Costa Pediatrics  (see #7 above for information about recruitment; see #22 above for a description of the 
clinics). 
25) Local Number of Subjects
Approximately 650 participants (325 families) will be screened, and 190 (95 families) will be enrolled. 
26) Confidentiality
The issues surrounding confidentiality are of supreme importance and sensitivity because personal 
information will be obtained from participants. Participants will sign a statement attesting to their 
understanding that the information they provide will be held as personal and confidential. To ensure 
confidentiality, all information will be coded so that it cannot be associated with any individual. A master 
sheet, with individual names and their respective code numbers will be kept in a locked file. All data entered 
into the computerized database will be identifiable by subject code number only. No one other than study 
staff members (under the supervision of study investigators) will have access to records identifying subjects' 
names at any time. All audio and video recordings will be stored in a locked filing video system located in our 
offices only accessible to study staff. These files will not be labeled with participants’ names but with the code 
numbers assigned to them at the beginning of the study. Participant first names only are used in audio 
recordings and they will be removed upon transcription such that all final transcripts are labeled only with 
participant numbers. Audio files sent to the National Captioning Institute will be sent using a Secure File 
Transfer Protocol (SFTP) that enables secure file transfer capabilities between networked hosts. The have 2 
SFTP servers available running Filezilla. They will provide me with an exclusive user account and password to a 
folder on the servers with restricted permissions to your account. All information gathered will be used only 
for scientific, educational, or instructional purposes.
27) Provisions to Protect the Privacy Interests of Subjects
During the recruitment and consent/assent process, and prior to any data collection, participants will be 
assured that their information is private, confidential, and will only be stored on internal University of Miami 
servers and accessed by study staff members. As described in #26 above, participants will be each assigned a 
unique code number to further protect their identity. Participants will be encouraged to ask questions during 
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the consent process and will be provided with contact information for the lead study investigators as well as 
for the University of Miami’s Human Subjects Research office. 
28) Compensation for Research-Related Injury
NA – research does not involve more than minimal risk 
29) Economic Burden to Subjects
NA – other than costs associated with transportation to and from data collection appointments, 
participants will not be responsible for any costs because of participation in the research 
30) Consent Process
For Aim 2: Study staff members will screen interested families remotely and confirm adolescents’ eligibility by 
measuring their height and weight in-person. Prior to data collection, study staff will present and review the 
consent form to the caregivers who are eligible to participate based on the inclusion/ exclusion criteria. The 
consent process will take place in-person or remotely via videoconference on e-consenting using REDCap. 
After the caregivers understand the study and after all questions have been answered to their satisfaction, 
individuals who elect to participate in the study will be asked to sign the consent form. The consent process 
will last approximately 30 minutes, but it may take caregivers more or less time depending on how clearly they 
comprehend study procedures. Participants will electronically sign and date the informed consent document 
prior to any procedures being done specifically for the study. Participants must be informed that participation 
is voluntary and that they may withdraw from the study at any time, without prejudice. An electronic copy of 
the informed consent document will be given to the participants for their records. If a parent is not available 
to complete consent, a legal guardian will be allowed to provide permission for the adolescent to assent. A 
legal guardian is a step mother or step father, or another person who has obtained legal rights to the 
adolescent. During the recruitment screening process, study staff members will determine if the primary 
caregiver is a legal guardian based on the provision of appropriate documentation.
For non-English speaking participants, consent forms will be made available in Spanish. Consent forms 
have been translated, back-translated and pilot tested for understanding in past studies conducted by 
the study investigators. 
Waiver or Alteration of Consent Process (consent will not be obtained, required information will not 
be disclosed, or the research involves deception) – Waiver of consent documentation will be 
requested for recruitment purposes. 
Prior to formal consenting/assenting procedures, parents and adolescents will provide verbal consent 
to have the adolescents’ height and weight measured by study staff to confirm their eligibility. Height 
will be measured using a stadiometer and weight will be measured using a digital or bioimpedance 
scale. Once participants formally consent for the study, parents will also have their height and weight 
measured and recorded. 
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Participants who are not yet adults, including adolescents ages 12-15 participating in the present 
study will go through a similar process as their parents. Their age will be confirmed with the pediatric 
clinic and/or the primary caregiver. After the parent or primary caregiver has consented, study staff 
members will present the assent forms to the adolescent. We will ask caregivers to give the adolescent 
privacy to prevent the adolescents from being coerced to participate. The assent process will last 
approximately 30 minutes, but it may take youth more or less time depending on how clearly they 
comprehend study procedures.
Cognitively Impaired Adults - NA
Adults Unable to Consent – NA
Authorization for Use and Disclosure of Protected Health Information (HIPAA) 
Patient medical records are being access for consent to contact and request is for a waiver of the 
requirement for written authorization from the patients to access their medical records.  
Confirm that you will destroy the Protected Health Information (PHI) you and/or your Study Team acquire 
receive from JHS and/or UHealth at the earliest opportunity. 
☒    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or UHealth  will not be re-used 
or disclosed to any other person or entity, except as required by law or for authorized oversight of the 
research study or for other research for which the use or disclosure of PHI is permissible.           
☒     I confirm  
31) Process to Document Consent in Writing
This study will be following “SOP: Written Documentation of Consent (HRP-091) with the exception of 
procedures described above to determine eligibility.” Consent forms have been uploaded for review. 
32) Drugs or Devices
NA – no drugs or devices are being tested in this study.
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