Healthy Kids at I-PAL (Interactive Physical Activity Lab)
Phase: NA
Conditions: Childhood Obesity
Sponsor: Pennington Biomedical Research Center

Protocol Title:  Healthy Kids Pilot
Co-PIs: Amanda Staiano, PhD, Corby Martin, PhD
Co-Investigators: John Apolzan, PhD
Medical Investigator: Daniel Hsia, MD
Sponsor: Internal funds 
Protocol Version Date:  8/15/2017
Objectives
Specific Aims
The current pilot study, entitled Healthy Kids Pilot, is a pilot & feasibility study to demonstrate the 
feasibility and acceptability of using an mHealth approach (i.e. intervention delivered over smartphone, 
iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and 
their parents. 
We will recruit up to 30 parent-child dyads into the intervention, where the designated child is between 
the ages of 6 and 10 years old, has a BMI percentile ≥ 85, free of diseases that affect metabolism, body 
weight, and food intake, including diabetes, HIV/AIDS, and cancer, and where the designated parent has 
a smartphone and is willing to use it for the intervention, including accessing the HealthTracker.
The primary outcome variable is acceptability/feasibility of the mHealth approach which will be 
evaluated by surveys of program acceptability and treatment satisfaction. Secondary outcomes will be 
change in BMIz in children and change in body mass of the participating parent.  The primary aim of the 
study is:
Aim 1: to determine if an mHealth approach to promote healthy behaviors and healthy weight among 
children and their parents will be utilized by parents of 6-10 year old overweight/obese children.
Number of Subjects and Subject Timeline
We plan to enroll up to 30 parent/child dyads over 1 year. Each parent/child dyad will participate in this 
study for approximately 3-4 months.
Study Timeline
This project will occur from August 28, 2017, to August 1, 2018. 
Setting
All evaluations and study procedures involving children and parents will be conducted off-site including 
at a local YMCA or other community locations or in the participant’s home.  The intervention will be 
conducted via remote counseling sessions delivered over the parents’ Internet-connected device. 
Pennington Biomedical IRB FWA 00006218
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Scientific Rationale
The prevalence of childhood overweight and obesity has increased markedly over the past few decades, 
with obese children at increased risk of obesity-related medical conditions. The most effective 
approaches to attenuate weight gain in children, and their parents, include family-based behavioral 
treatments that concurrently target children and parents to promote healthy eating and exercise using 
behavioral management techniques to make sustained behavioral changes. However, in-person 
counseling is difficult to disseminate on the scale necessary to impact childhood obesity at the 
population level, and many families face barriers related to scheduling conflicts and transportation. 
Mobile health (mHealth) approaches promise to overcome barriers to the translation and dissemination 
of effective interventions and offer the ability to remotely monitor patients’ progress and deliver 
treatment. Indeed, our multidisciplinary team of behaviorists, dietitians, and physical activity experts at 
Pennington Biomedical Research Center has shown that it is feasible to deliver mobile phone based 
interventions to parents that target their child’s behavior and that when these programs are based on 
behavioral theory, they can be effective. 
This protocol is a pilot & feasibility study that will provide data on acceptability, feasibility, and 
estimates of effect size for an R01 submission. The R01 submission will test the efficacy of a family-
based weight management intervention (FWM) to reduce obesity in 198 children aged 6 to 10 years and 
their obese parents using two delivery modalities:  in-person (n=84) vs. mHealth (n=84), compared to a 
health education control (n=30) group, over two years. The mHealth intervention will include remote 
behavioral counseling and include remote tracking of body weight, physical activity, and food intake. 
The overall goal is to leverage mHealth to reduce childhood obesity in a way that is both effective and 
acceptable for wide dissemination.
Sample Size Justification
This protocol is a pilot & feasibility study that will provide data on acceptability, feasibility, and 
estimates of effect size for an R01 submission. A sample size of up to 30 dyads will provide sufficient 
data for feasibility and acceptability.
Planned Statistical Analyses
To determine if this mHealth approach to promote healthy behaviors and healthy weight among 
children and their parents will be utilized by parents of 6-10 year old overweight/obese children, 
descriptive statistics will be used to examine adherence and scores on the treatment acceptability and 
treatment satisfaction surveys.
To obtain preliminary estimates of effect sizes, we will use mixed model analyses using an intent-to-
treat approach. Model selection criteria using Akaike information criterion (AIC) will be employed to 
determine the best set of covariates, including, but not limited to, baseline demographic (e.g., sex, race) 
and anthropometric variables. T-tests based on the least squared means derived from the model are 
used to test the treatment effects. Responses such as change in body mass (kg and percent for the 
parents; BMIz for the children), physical activity, energy intake and diet quality, and treatment 
satisfaction and burden, will all be used in the mixed effect model and we will specifically include race 
and sex in the model to test if biological variables, such as sex, are associated with the outcomes. 
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Methods
Study Participants.
To be eligible for the study, the child must:

Be 6-10 years of age

Have at least one participating parent. 

Have a BMI percentile > 85

Be physically capable of exercise

Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or 
type 2 diabetes, HIV/AIDS, and cancer 
To be eligible for the study, the parent must:

Have a smart phone

Be willing to use the smartphone for the mHealth intervention, including accessing the 
HealthTracker
Exclusion criteria for the child include:

Significant cardiovascular disease or disorders via self-report from parent

Other significant medical problems that would prevent them from engaging in regular physical 
activity.  
Visits/Procedures
Below are the procedures that will be completed during study participation:
Procedure
Screening/
Baseline
Intervention
End of Study
Follow-up
Assessment of or by the Parent
Orientation Presentation
x
Consent
x
Height/Weight
x
x
Questionnaire (Medical History Survey)
x
Acceptability Survey
x
Pedometer (daily)
x
RFPM (monthly)
x
Treatment Satisfaction Survey
x
Assessment of Child
Orientation Presentation
x
Assent
x
Height/Weight
x
x
Questionnaire (Lifestyle Survey, Treatment 
Satisfaction Survey)
x
x
Pedometer (daily)
x
RFPM (monthly)
x
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Visits 
Recruitment
Using a study flyer we will advertise through the public library system, seek support of community 
leaders, issue personal appeals through social organizations, and place advertisements in places of 
congregation.  Participants will also be recruited using traditional advertisement mediums if necessary, 
including newspaper, radio, television, and social media. We will actively recruit new potential 
participants from the Pre-PLACE and other pediatric studies, and we will submit a privacy board request 
to recruit participants who were recently deemed ineligible from the Pre-PLACE study and other recent 
pediatric studies.
Telephone Screen
We will perform an initial telephone screen to determine if the potential participant appears to meet 
eligibility criteria.  Individuals deemed eligible from the telephone screen will then be scheduled for a 
screening visit and will receive the consent/assent form by email.
Screening/Baseline Visit
The screening visit will occur at a local YMCA or other community locations or in the participant’s home. 
Participants will be formally oriented to the study by receiving detailed information on the purposes, 
goals, procedures, participant flow, and timeline.  A parent will sign an informed consent.  Participants 
ages 9-10 will sign a written assent form.  Participants ages 6-8 will provide a verbal assent for 
participation.  Parents will complete a program acceptability survey and complete a medical history 
questionnaire for their child. Children will complete the Lifestyle Survey. Height and weight 
measurements will be taken for both the child and parent.  If they meet initial inclusion criteria based on 
the information collected, the parent/child dyad will meet with an interventionist to conduct or 
schedule an initial face-to-face counseling session.
Follow-up Assessment Visit
Parent-child dyads will return to a local YMCA or other community locations or in the participant’s home 
for a follow-up visit at 14-16 weeks following the commencement of the intervention.  Participants will 
have their height and weight measured and complete surveys. 
Procedures
Program Acceptability/Treatment Satisfaction Surveys
Parents will complete a survey assessing program acceptability at screening and a survey assessing 
treatment satisfaction at the final assessment visit. 
Medical History
Parents will completea medical history questionnaire for their child.
Lifestyle Survey
Children will complete a lifestyle survey assessing sleep, dietary and physical activity habits, and media 
use.
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Anthropometry
Height and weight will be measured using a portable stadiometer and a scale. Measurements will be 
taken without shoes and recorded to the nearest 0.1 cm and 0.1 kg.
Intervention
Parent/child dyads will attend remote counseling sessions (each approximately 30 minutes) delivered 
over their Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer).  A 
Pennington Biomedical counselor will deliver the lesson, review progress based on the objectively 
measured data available on the HealthTracker; more detail below), and provide individualized advice 
and problem-solving strategies for the parent and the child. Counselors will attempt to meet face-to-
face with parents for the initial intervention session.  Eight lessons will be delivered electronically via 
smartphone, iPad/tablet, laptop, or desktop computer. Over the course of the 14-16 week study, 
families will also receive weekly contact via smartphone (most interactions will be via FaceTime, Skype, 
or phone, but email and text communication will also occur). Each lesson will include an interactive 
component for the parent and child related to healthy eating and active play, as well as an interactive 
parenting training component. The lessons are based on the family treatment methods that effectively 
promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 
1981).
The parent lessons are framed around these guiding principles: 1) weight and activity monitoring; 2) 
behavioral contracting with a goal of modeling appropriate strategies; 3) review of progress and 
problem-solving to address poor adherence to behavioral goals; and 4) food monitoring and goal setting 
for nutrient intake. Specific lessons will focus on how to motivate the child and how to manage non-
compliance including praise and reward, positive reinforcement, selective ignoring, contracting, pre-
planning for meals and physical activity, shaping behaviors, modeling, changes to the home 
environment, and facilitating social support for behavior change (Newton et al., 2011; Staiano et al., 
2017). The dietary approach will employ food monitoring and goal setting for nutrient intake following 
the Traffic Light Diet, an effective approach for children and their parents within a clinically supervised, 
multi-component weight management program (Epstein et al., 1990). Foods are categorized as green, 
yellow, or red based on caloric density, and children and parents are given a goal to stay within a 
prescribed daily calorie range and to eat no more than four red foods each week. We will work with the 
parent to make systemic changes to what is served and how it is prepared in the home, focusing on 
preparation methods that decrease energy density and dietary fat, such as baking rather than frying 
foods. The physical activity approach will introduce free or inexpensive activity options and address 
barriers to physical activity. Counselors will work with parents to increase opportunities for play and 
activities that they and their children enjoy. We successfully used these lessons in prior and ongoing 
pediatric trials (Staiano et al., 2017; Williamson et al., 2005; Williamson et al., 2006) and have updated 
them over time. Specific targeted psychosocial constructs include increasing quality of life through 
active play and improving eating attitudes through modeling and introduction of healthy foods.
The HealthTracker is Internet-based software that allows us to deploy the intervention as an EMI 
(Ecological Momentary Intervention) and Just in Time Adaptive Intervention (JITAI). The HealthTracker 
serves as the “hub” of intervention delivery for the counselors and participants, and it promotes 
treatment fidelity, ongoing communication and progress reviews between the remote counseling 
sessions, and structures intervention delivery for the counselors. Further, the HealthTracker remotely 
collects objective data, namely body weight, in near real-time and these data are used to facilitate 
behavior change during the mHealth intervention, consistent with learning theory. The intervention is 
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Approved 08/24/2017

based on the theory of planned behavior and the theory of reasoned actions (Ajzen, 1991) by fostering 
an environment conducive to behavior change where participants’ behavioral goals are clearly defined, 
self-efficacy is promoted, and behavior is regulated through objective data. The intervention also 
incorporates aspects of social cognitive theory (Bandura, 1988) by reinforcing behavior change and 
fostering personal agency, clear outcome expectations, and goal setting. Though the counselor and 
participant’s relationship is remote and relies on communication technology, counselors are able to 
deploy motivational interviewing techniques to address decreases in motivation, which are inevitable in 
longer-term interventions (Patrick & Williams, 2012).
Component
Frequency
mHealth (HealthTracker with Virtual Counseling)
Lesson & 
Material Delivery
      
Weekly (Wk 1-4)
Biweekly (Wk 6-14)
Counselor delivers 8 lessons to the child and parent during 
remote counseling sessions over video chat or phone call. 
Body Weight 
     
Daily (parent)
Weekly (child)
Sent automatically from the Body Trace Scale in the home to 
the HealthTracker.
Within minutes, the Weight Graph for the parent with 
individualized target weight zones are available for the parent 
and counselor on HealthTracker.
Children will be asked to weigh weekly, therefore the child 
weight graph will be sent remotely to the parent once per 
week.
Physical Activity 
     (steps/day)
   
Weekly
The Steps Graph for the parent, including individualized 
steps/day target, are available for the parent and counselor on 
HealthTracker.
The step graph for the children will be sent remotely to the 
parent once per week
Food Intake 
     (kcal/day)
     
Monthly, 
with ~1 week of data 
per month
Weight graphs will be continually used a proxy for adherence 
to energy intake targets. For nutrient information, parent 
captures own and child’s food images using Remote Food 
Photography. Images are automatically transmitted via the 
SmartIntake app.50,51
The intervention largely is based on our previous successes with an mHealth weight management 
intervention for adults called “SmartLoss” (Martin et al., 2015; Martin et al., 2016). SmartLoss is an 
EMI and JITAI that promotes behavior change via the real-time capture of objective body weight and 
activity (step) data from participants’ home environment. These data are wirelessly transferred to the 
Internet where they are graphed in relation to 
the individual participant’s weight and step 
goals by our software and sent back to 
participants via their smartphone (these graphs 
are also available for the counselor, see Figure). 
One cornerstone of SmartLoss is the ability to 
objectively quantify adherence to energy intake 
goals based on observed body weight. To 
achieve this aim, we developed and validated 
differential energy balance equations (Thomas 
et al., 2010) that predict weight change over 
time for an individual based on a prescribed 
energy intake target. Our software generates 
individual weight graphs that display the expected amount of weight loss over time, and the model 
Weight Graph Zone of Adherence (Parent).
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also generates upper and lower bounds around predicted weight loss. As shown in Figure 3, this 
creates a “zone of adherence” and a participant’s body weight is plotted over time in relation to this 
zone. The participant is considered adherent to the diet if their weight falls within the zone; hence, 
change in weight serves as a proxy for energy intake/dietary adherence. This graphical feedback is 
used by counselors and participants to deploy different treatment strategies to modify energy intake 
to improve adherence.  
Customization of the HealthTracker and the Intervention. The HealthTracker will be accessible 24 
hours per day by counselors and parents anywhere that has Internet access (including mobile devices), 
and the data in the HealthTracker are available in near real-time. Parents will interact with the 
HealthTracker to review their step and weight graphs.
Weight Graphs 
Children and parents assigned to the mHealth 
intervention will each receive a Body Trace scale that 
wirelessly and automatically transmits their data to a 
website. Parents will be asked to weigh daily and 
weigh their child weekly, unless contraindicated due 
to anxiety, etc. The HealthTracker will plot the 
parent’s weight on a graph (Figure 3). The child’s 
weight graph is delivered remotely each week and will 
be plotted two ways, with the counselor seeing both 
plots and the parent only being able to see one plot 
(access to HealthTracker is password restricted).
 As illustrated in the upper panel of Figure 4, the 
parent will see their child’s weight in pounds plotted 
on a graph that has a zone of adherence that is flat 
over time and consistent with our recommendations 
to attenuate weight gain and reduce BMIz compared 
to the control group. The initial zone for the child will 
be set at their current weight ±3 pounds (we recognize 
this is an arbitrary zone, though we used a similar 
guideline in the DRIVEE study successfully). As noted earlier and illustrated in the lower panel of Figure 
4, two safety criteria are evaluated by the study team in real-time via the HealthTracker to identify 
children who might decrease body mass too much and/or too quickly. Specifically, children will be 
identified who: 1) lose > 0.20 BMIz in any four-week period, or 2) obtain a BMIz < 0.25 which 
corresponds to the 60th BMI percentile. The weight graphs are available in real-time to the parents (and 
their children), and parents will receive copies of their and their child’s most recent graphs every time 
they are contacted by their counselor.
Physical Activity
The child’s daily activity (steps/day) will be tracked with a pedometer. The parent will be asked to 
document their child steps daily.  The counselor plots the child’s daily step data in relation to their 
individual goals. These step graphs are then used to help promote adherence to participants’ activity 
goals. The pedometer has low participant burden and is worn on the waist. The parent and child’s step 
Figure 4. Weight Graph Zone of Adherence 
(Child).
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graph will be available weekly during the interventions sessions and will be delivered to the parents on 
the same schedule as the weight graph. 
Food Intake
The weight graphs serve as a proxy measure of energy intake. Hence, recommendations to change 
energy intake will be guided by participants’ body weight in relation to their individual zone. The 
Remote Food Photography Method (RFPM) and SmartIntake smartphone app, however, will also be 
used by the parents to provide the intervention team with information that they can use to help the 
parents modify their food preparation methods, portion sizes, shopping lists, and food choices to 
maximize the likelihood that the parents can adhere to their and their child’s energy intake goals. Food 
image data from family meals (e.g., breakfast, dinner, afternoon and evening snacks) are extremely 
helpful in helping people to modify their food intake, particularly since these data are captured and 
transmitted to the study team in real-time. 
RFPM data are collected with the SmartIntake app by parents who will use the app to capture images of 
food selection (and plate waste after meals). The app has barcode scanning capabilities and a Price 
Look-up (PLU) number entry system to easily identify foods in the images. The app also has text and 
voice message capability, allowing participants to easily record food descriptors that are automatically 
tagged to the food image. The SmartIntake app sends participants’ food images to a Pennington 
Biomedical server where the images can be viewed on an Internet-based platform by the intervention 
team in real-time (and/or analyzed to calculate energy and nutrient intake). The RFPM includes 
Ecological Momentary Assessment (EMA) methodology to promote data quality and completeness by 
sending text messages or reminders to participants to capture images of the foods and beverages that 
they consume at their personalized meal times. 
Data Safety Monitoring Plan
The proposed research risks are no greater than that ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests (i.e. minimal risk).  Therefore, 
the protocol does not warrant the establishment of an independent Data and Safety Monitoring Board 
(DSMB). This Data and Safety Monitoring plan describes the safety monitoring procedures for the 
proposed study, including a description of how often and to whom serious and unexpected adverse 
events will be reported. The plan will help ensure the safety of all participants. The PIs will communicate 
via electronic submission to the IRB all unanticipated problems as defined by the IRB and all serious 
adverse events (SAEs) to the medical investigator within 24 hours.  All less serious adverse events will be 
reported to the medical investigator within 3 days of occurrence. 
1)
Measurement and reporting of subject accrual, adherence to inclusion/exclusion 
criteria, protocol adherence, and rates of study completion  – Review of subject accrual, 
adherence to inclusion/exclusion criteria and study procedures as listed in the protocol, 
and rates of study completion will occur every two months. These data will be reviewed 
by the study PIs.  
2)
Stopping rules – Data on subject accrual and completion rates will be synthesized and 
evaluated yearly to determine if the study should be terminated. One of the most likely 
reasons for early termination is the failure to recruit or retain participants; therefore, 
these data will be evaluated yearly to determine if failure to recruit or attrition is 
jeopardizing the ability to empirically test the study aims. 
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3)
SAEs will be monitored quarterly by the study PIs and Medical Investigator, to ensure 
proper SAE reporting and to regulate procedures to protect participant safety.
Data Management and Confidentiality 
The Ingestive Behavior Laboratory and Pediatric Obesity and Health Behavior Laboratory will have 
primary responsibility for data collection, data management, manual data entry, and data analysis. All 
electronic data will be stored in the secure Pennington database, with access given to only necessary, 
HIPAA-certified staff.  All hard copies of data will be stored in a secure, locked cabinet at Pennington 
Biomedical Research Center.  Data collected at the sites will be securely transported to PBRC. Access to 
data files can be made only with permission of the Principal Investigators.  Data will be stored for 5 years 
following study completion.
Withdrawal of Subjects 
Participation is voluntary, so participants may withdraw from the study at any time. Data that have 
already been collected during the course of study participation from a withdrawn participant will be 
used, unless a specific request is otherwise received.  Participants may be withdrawn from the study at 
the discretion of the study PIs.
Risks/Benefits to Subjects
The proposed research risks are no greater than that ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests (i.e. minimal risk). The risks for 
physical, psychological, social, or legal harm are minimal for the testing procedures planned for this 
study.  Our research staff members have performed all testing procedures in many studies with no 
serious adverse events.  There may be risks associated with changing dietary intake, but these will be 
mitigated by the interventionists who will counsel participants during the mHealth sessions and will 
perform periodic dietary assessments during the intervention. Children and parents will be asked to 
gradually increase their physical activity during the intervention. Risks to individuals who increase 
physical activity are rare, but could include: temporary shortness of breath similar to moderate exercise, 
muscle soreness the following day, dizziness, fainting, blood pressure elevation, irregular heartbeat or 
heart attack, mild irritation of the skin from the wearable step measuring devices used to measure 
physical activity. In addition to the risks listed above, participants may experience a previously unknown 
risk or side effect. Risks associated with study procedures will be continually assessed and monitored 
throughout the study by the investigators.
Compensation for Research-Related Injury 
No form of compensation for medical treatment or for other damages (i.e., lost wages, time lost from 
work, etc.) will be available for this research study. In the event of injury or medical illness resulting from 
the research procedures, participants will be referred to a treatment facility. 
Compensation 
The total compensation for the study is $125 to be paid by check. The child can earn up to $50 and the 
parent can earn up to $75 for completion of the study. Both the child and the parent will each receive 
$25 for completing the Screening/Baseline assessment. The child will receive $25 and the parent will 
receive $50 for completing the end of study follow-up assessment. 
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