A Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight Loss App
Phase: NA
Conditions: Obesity
Sponsor: Baystate Medical Center

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
2/25/19 
 

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Protocol Title: A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric 
Centered Weight Loss App 
 
Principal Investigator: Rushika Conroy MD MS 
Research Coordinator: Victoria Cobb 
Statistician: Alex Knee, MS 
 
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
 
Background  
As a result of childhood obesity and its comorbidities, this generation of children might be the first to 
not outlive its parents. The national prevalence of adolescent obesity has increased from 5% to 21% 
over the last five decades (1). Even more discouraging is that youth are being afflicted with the same 
obesity-related comorbidities that are affecting adults. Conditions such as type 2 diabetes, 
hypertension, non-alcoholic fatty liver disease, dyslipidemia, metabolic syndrome, and sleep apnea are 
being diagnosed in children at younger and younger ages.  
 
Lifestyle modification continues to be the cornerstone of treatment for obesity and its associated 
conditions. The basic concept behind lifestyle modification is a balance of caloric intake and caloric 
output.  Lifestyle modification alone has shown to result in on average 5-10% weight loss over a 6 month 
period in adults or a 1-2 kg weight loss over 6-12 months (2, 8). In pediatrics, weight loss is generally not 
used a marker of success given that the child is still growing linearly in most cases. Thus, changes in BMI 
and/or BMI z-score are utilized to measure success. Pediatric studies cite improvements in BMI z-score 
ranging from 0.004 to 0.42 with most studies averaging a 0.1-0.2 decrease in BMI z- score over 6 to 12 
months (3, 4). 
 
The pediatric weight management program at Baystate Medical Center sees children and adolescents 
from the ages of 2-20 years. Standard care for the program involves monthly visits with a physician 
(either a general pediatrician or pediatric endocrinologist) or a nurse practitioner in addition to visits 
every 3 months with a registered dietitian. During each visit, food and activity recalls are conducted and 
1-2 goals are made with the patient and their caregivers that focus on improving the quality and 
quantity of the patient’s intake as well as increasing physical activity. Goals are personalized and are 
adjusted to meet the social, psychological, financial and motivational needs of the patient.  
 
Sixty four percent of Americans own smartphones (5). The use of smartphone apps for health and 
wellness has sky rocketed as more sophisticated and user friendly apps are being developed to assist 
with weight loss, healthy eating, exercise and tracking food and activity. Digital tools can allow one to be 
constantly aware of how much they are eating and expending, which may result in an improvement in 
overall weight loss. In adults weight loss of 1-5 kg over a 6 month period is achievable using tools such as 
food log apps (6, 7). Such apps are generally suited for adults only and the few weight loss apps targeted 
toward the pediatric population have not been validated by weight loss programs. Apps that are 
available for younger patients have been criticized for containing inadequate expert recommended 
strategies for achieving a healthy weight, lack of goal setting, and poor provision of education.  
 
Kurbo is a health and fitness app that is targeted toward the pediatric population. It utilizes games and 
activities to educate children about healthy eating, portion control/size and exercise. It allows for food 
tracking by using servings of macronutrients and food groups and sets goals for achieving a healthy BMI 
through modification of diet intake. In addition to being created solely for children and adolescents, a 
unique feature of this app is an option to speak with a personal health coach on a regular basis to obtain 
feedback, advice and encouragement. Studies suggest that weight loss outcomes are best with more 
frequent contact hours but most weight loss clinics, including ours, are not equipped to meet with 

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patients on a weekly basis or even monthly basis.  The personal coaching aspect of Kurbo is expected to 
improve outcomes by increasing user access to feedback and advice.  
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
Specific Aims 
 
The purpose of this pilot study is to assess the feasibility, compliance with and effects of a pediatric 
centered weight loss app on BMI z-scores in a group of children and adolescents in a pediatric weight 
management program. We will assess the impact of the app as an adjunct to current weight 
management therapy, both with and without the personal health coach (PHC) option. We propose the 
following primary specific aims. 
 
Primary Specific Aims & Hypotheses 
1. The Primary aim is to assess 3 month compliance with the Kurbo app as well as the 
Kurbo app and PHC by a group of morbidly obese children and adolescents in a 
weight management program. 
a. We hypothesize that compliance with the Kurbo app and Kurbo app plus 
PHC will be better than known compliance of our standard of care group.   
2. The Secondary aim is to assess the effect of the Kurbo app as well as the Kurbo app 
and PHC on 3 month change in BMI-z score among morbidly obese children and 
adolescents undergoing a weight management program.  
b. We hypothesize that the use of the Kurbo app and Kurbo app plus a 
personal health coach will result in a greater reduction in BMI z-score over 3 
months than known change in our standard care group. 
c. We hypothesize that the use of the app and personal health coach will 
result in a greater reduction in BMI z-score over 3 months than with the use 
without the personal health coach. 
 
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
Methods 
Study Design: We wish to establish that Kurbo and/or Kurbo + PHC have better compliance and/or 
change in BMI-z scores than our current standard of care.  To do this we will use two single arm studies, 
where subjects will be randomized into either group; however, each will be compared to our known 
standard. Assuming that we can establish better compliance and/or change in BMI-z score, we will also 
generate descriptive estimates using a parallel randomized trial design comparing the two groups 
(Kurbo vs. Kurbo + PHC). 
 
Setting:  Baystate Children’s Hospital is an academic medical institution affiliated with University of 
Massachusetts School of Medicine. The Baystate Medical Center Pediatric Weight Management 
program sees patients from the ages of 2 through 20 years for the management of obesity and its 
comorbidities. Visits take place every 4-6 weeks with a physician, and visits with the dietitian occur 
about every 3 months. There are currently over 600 patients in the weight management program, with 
more than half in the pre-adolescent and adolescent age groups. The clinic is composed of two 
physicians (one general pediatrician and one pediatric endocrinologist), a nurse practitioner and three 
dieticians.  Visits are conducted at the outpatient pediatric subspecialty center in Springfield, 
Massachusetts. 
 
Inclusion Criteria:  Subjects will be screened in and approached based on the following criteria: 
1. At least 10 years and no more than 17 years of age 
2. New patients presenting to the Baystate Children’s Hospital pediatric weight management 
program  
Exclusion Criteria:  Subjects will be excluded if any of the following conditions are met. 
1. Do not own or have regular access to a smartphone 
2. Cannot read and understand English language as  Kurbo is currently only designed for English 
speakers 
 
Screening:  On average, about 22 new patients are seen in our weight management clinic each week. 
Identification of potential study subjects will be conducted by the Pediatric Endocrinology research 
coordinator by reviewing the clinic schedule available on Centricity. In order to avoid competition with 
an existing study, we will begin our screening process at their second appointment in the weight 
management program (approximately 4-6 weeks following their first visit).   In order to track our 
recruitment rates, we will maintain a list of all screened in patients in our REDCap database.  Subjects 
meeting initial inclusion criteria will be approached during their clinic visit in order to assess additional 
eligibility criteria (smartphone access, ability to read and understand English).  These discussions will be 
held in a private examination room with the patient and a family member or legal guardian.  Following 
confirmation of eligibility, the research coordinator will begin the consent process. 
 
Consent Process:  Interested and eligible patients will be consented by the Pediatric Endocrinology 
research coordinator in a private examination room. The consent will be reviewed with the patient and 
caregiver and up to 48 hours will be given for the patient to consider agreeing to participate in the 
study. Questions will be answered at the time of review of the consent and can be asked for up to 48 
hours as well.  
 

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Baseline Assessment: Following the consent process, subjects will be assisted with downloading the 
Kurbo app to their smartphones and will be instructed to go through the brief tutorial on use of the app 
by the research coordinator. Additional baseline data will be abstracted from the medical records based 
on their first standard of care visit.  For example, all subjects are weighed and measured to the nearest 
0.1 kg and 0.1 cm, with a standard seated digital scale and calibrated stadiometer, respectively. BMI is 
calculated as weight in kilograms divided by height in meters squared. BMI z-score is determined by the 
standard deviation of the BMI from the mean.  
 
Randomization, Allocation and Blinding: A random permuted stratified block randomization scheme will 
be generated by the Baystate Epidemiology/Biostatistics Research Core (EBRC) and imported into 
REDCap.  Stratification will include two levels: patients aged 10-14 and 15-17 years old.  We wish to 
stratify as the younger group may have more parental oversight and assistance with managing Kurbo, as 
well as answering survey questions. The REDCap module will conduct the allocation based on the 
randomization scheme.  During the baseline assessment, subjects will be randomized by the research 
coordinator to Kurbo or Kurbo + PHC using the Tufts REDCap randomization module.  The research 
coordinator will click on the randomization button and alert the subject to which group they have been 
assigned. Discount codes will be provided to the RC to use when purchasing the Kurbo PHC. In order to 
register for Kurbo, subjects will need to provide a first and last name, date of birth, phone number and 
email address. For subjects under the age of 12 years, a parent or caregiver must attest that they are 
allowing his/her child to sign up for Kurbo during the registration process. For further details regarding 
Kurbo’s HIPAA and security rights, please see attached letter from Kurbo. Clearly, we will not be able to 
blind the subject or the research coordinator, however attempts will be made to blind the study PI.  
Although the PI will have access to REDCap in terms of recruitment and baseline information, their read 
access will be restricted by the EBRC so that she is blinded to randomization and allocation.  The 
research coordinator will instruct the subjects to not discuss their group assignment with the PI. In 
addition, subjects will be instructed to not purchase the PHC during the study window.  Although the PI 
will be blinded to all surveys and group status, but will be aware of weights throughout the study as this 
is part of standard of care.  The research coordinator will have access to all of this data as their main role 
is to implement the protocol and ensure complete and accurate data collection.  However, in order to 
minimize their influence and awareness of subject responses for surveys we will implement the 
following procedure:  During a scheduled visit, the research coordinator will open up a survey link for 
the patient on a Baystate PC and then will leave the exam room giving subjects privacy while answering 
survey questions.   Subjects will be instructed to submit the survey using the button at the bottom of the 
survey and request for the research coordinator to return.  Although not formally blinded, the research 
coordinator will be instructed to not view the survey responses (they will only see if they are 
complete/incomplete or partially complete) or have conversations with subjects in regards to 
compliance.   
 
 
Follow-Up:  As part of standard of care, subjects will be seen every 4-6 weeks during their regularly 
scheduled weight management appointments to assess height, weight, and to calculate BMI. The 
subject will meet with a dietitian for further guidance and recommendations at baseline and the end of 
the study (approx. 3 months) and will meet with the physician for a routine exam at each visit as per 
standard of care in our pediatric weight management program.   In addition to standard of care, at each 
visit subjects will complete the questionnaire as described above.  Branching logic will be used within 
REDCap to direct appropriate questions to subjects with or without the PHC.  The questionnaire is 
designed to assess compliance (see measures section).  A separate survey will be used at the final visit; 
however the same survey procedures will be followed.  During the 3 month study window we expect up 

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to 4 time points (baseline, months 1, 2 and 3(the final visit).  If visits do not fall every 4 weeks, then 
fewer interim data points will be collected.   
Measures:  We will gather data from a variety of sources including EMR documentation (for standard of 
care visits) as well as subject surveys. 
 
Exposure: Using the two-single arm study design, we will compare Kurbo vs. our known standard and 
Kurbo + PHC vs our known standard.  Our standard of care estimates are based on existing data from a 6 
month Baystate pediatric weight management spinoff called MIGHTY. Both MIGHTY and Kurbo could be 
considered augmented programs that spin off of our pediatric weight management program.   MIGHTY 
stands for Moving, Improving, and Gaining Health Together at the YMCA. It is an intensive six-month 
group program that emphasizes physical activity, nutrition, and change of habits for the entire family. It 
includes a fitness evaluation, individual fitness prescriptions, group exercise sessions, individual and 
group nutritional counseling as well as strategies for maintaining lifelong health. Families who 
participate in MIGHTY receive a free six-month membership to the Springfield YMCA. Children 
interested in enrolling in MIGHTY must first be evaluated through our Pediatric Weight Management 
Program.   Estimates from this program will be adapted for our power calculations. 
 
If we can establish that Kurbo is better than our known standards, then we will estimate differences 
between Kurbo vs. Kurbo + PHC.  Group assignment will be randomized in a 1:1 ratio using random 
permuted blocks.   
 
 
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
Outcomes 
 
Compliance: The compliance measure from our known standard (MIGHTY program) is showing up for a 
visit (e.g. attendance).  As comparable measures, we will define compliance with Kurbo app to be daily 
use for tracking food intake, exercise, accessing the app features (games, badges).  Surveys will have 
specific questions such as: “Over the last month, how many days per week do you usually use Kurbo to 
track food?” A summary compliance score will be calculated as follows:  we expect subjects to use Kurbo 
to track food daily (7 days per week). Over the 3 follow-up study visits, if a subject responds to the 
above question with a 7, 5 and 6, we will take the average of this and divide it by the expected.  In the 
above example: 18/3 = 6 and 6 / 7 = 85.7% compliant.  Expected compliance for using Kurbo to track 
exercise = 7 days. There is no expected compliance for the use of games and obtaining badges.  
 
Compliance with the PHC will be assessed based on the subjects’ ability to have these meetings at least 
once a week. In order to collect this information we will ask “Over the last month, how many total 
meetings have you had with your personal health coach?”  Compliance will be assessed in the same way 
as defined above with the expected compliance of 4 times in the last month.   Use of the coaching 
feature will be defined as a complete phone or video conference. We will also assess the number of 
times they needed to reschedule these PHC visits.  
 
BMI-z score: This is standard of care data that is recorded in PEDRO. The research coordinator will 
gather relevant BMI-z score data from PEDRO and enter it into REDCap for all study visits.    
 
Covariates: We will collect the following from the EMR (age (yr, mo), height (cm), weight (kg), insurance 
category (private vs public), sex, race, and ethnicity).  We will also ask subjects what their current grade 
level is. 
 
Study Timeline:  We plan to recruit 70 subjects within the first 6 months of protocol acceptance.  With 
nearly 22 new patients a week we do not anticipate that recruitment will take longer than 2 months, 
however we will leave our recruitment window open for 6 months at which time we will close 
recruitment, even if we have not accrued 70 subjects.  As the Kurbo intervention is 3 months in 
duration, we expect the full implementation of this study to last approximately 9 months.  Data analysis 
will be initiated by the EBRC at the completion of data collection.  We anticipate analysis to take 3 
months.   
 
Prior Studies and Feasibility: As this is a pilot study, no preliminary studies have been conducted in 
support of this study. We anticipate timely recruitment given the high volume of new patients in our 
weight management clinic. In order to establish feasibility for a larger study, we will measure participant 
compliance and other feasibility measures with this pilot study.  
 
The Principal Investigator has experience in conducting retrospective trials, drug treatment trials, 
prospective and randomized controlled trials during her time at Baystate as well as during her 
fellowship. Other members of the team, including the research coordinator and other providers, have 
also had some research experience in retrospective and prospective randomized controlled trials.  
 
 

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Data Analysis: We wish to evaluate two outcomes (compliance and BMI-z score change) among two 
groups (Kurbo and Kurbo + PHC).  To do this we will use two single arm studies, where subjects will be 
randomized into either group, however each will be compared to a known standard. In this case, the 
known standards (based on existing data from our usual care group) are based on a 6-month compliance 
rate of 50% and a BMI-z score decrease near 2% (BMI-z score at baseline=2.27 vs. 6 months=2.22). To 
adapt these to a 3-month intervention, we feel that compliance at 3 months will remain the same (50%) 
and BMI-z change will be around 1% (BMI-z score at baseline=2.27 vs. 3 months=2.25). 
 
Upon completion of the study, data will be inspected for outliers and logic checks will be conducted. 
Initial results will include means, standard deviations, medians and ranges for continuous measures and 
frequencies and percentages for categorical measures.  Graphical representations will be utilized as 
needed.   
 
To assess our hypotheses we will utilize one-sample tests with a one-sided alpha of 0.025.  One-sided 
tests will be used as we are only interested in whether the use of this app results in better outcomes 
than usual care. Compliance will utilize a binomial probability test to assess compliance (calculated over 
3 months) against our known compliance of 50%. BMI-z score change (absolute change from baseline to 
3 months) will utilize a one-sample t-test to assess observed BMI-z score change at 3 months against our 
estimated change of a 1% decrease.  We will present our findings graphically, along with point estimates 
and one-sided 97.5% confidence intervals.   
 
Assuming we find improved compliance and BMI-z scores, we will also estimate compliance and BMI-z 
score differences between Kurbo and Kurbo + PHC.   Estimates will be generated using direct 
observation as well as prediction through modeling (e.g. GEE, linear mixed models). As data will be 
collected monthly, we will also describe changes over time and any possible dose-response effects.  We 
will also evaluate possible differences in effects based on age category stratification (10-14 yrs and 15-
17 yrs).  We will present our findings graphically, along with 95% confidence intervals.  These results 
may be used to inform study design and power calculations for a future study assessing differences 
between Kurbo and Kurbo + PHC as well as changes in obesity-related comorbidities.  
 
Power and Sample Size: Studies in pediatric and adult weight management trials indicate that the 
attrition rate is poor (4, 6, 8) as well as unpublished data from our pediatric weight management spin off 
program, MIGHTY, indicate that 6 month compliance (attendance) is close to 50% and 6 month change 
in BMI-z scores is approximately a 2% decrease with a change standard deviation (SD) of 0.12.  As 
described in our data analysis section, we will estimate compliance to be 50% and BMI-z decrease 1%.  
We will keep the same SD of 0.12.  Sample size calculations assume a one-sided alpha of 0.025, and 
power of 0.80.   
 
 
In regards to compliance, we feel that to be of clinical importance we would want to observe close to 
75% compliance with the Kurbo app and/or Kurbo + PHC.  With a sample of 30 subjects in each Kurbo 
group (60 total), we would be able to conduct a one-sided, one-sample test against 50% compliance if 
we observe at least 75% compliance in our study groups (a 25% improvement in compliance).  Larger 
samples would be required to test a smaller effect size (e.g. nearly 50 subjects per group would be 
required to test 70% compliance against 50%) and with the same sample size power would drop to 0.59 
to test a 20% difference.   
 
 
In regards to BMI-z score change, we feel that to be clinically relevant we would want to observe at least 
a 5% decrease (BMI-z score at baseline=2.267 vs. 3 months=2.154) in BMI-z score over a 3 month period 

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with the Kurbo app and/or Kurbo + PHC.  With a sample of 12 subjects in each group, we would be able 
to conduct a one-sided, one-sample t-test against a 1% decrease assuming a standard deviation of 0.12 
if we observe at least a 5% decrease in BMI-z score in our study groups.  Effect sizes greater than the 4% 
difference described above will be picked up by this sample size.  However, in the case that we have 
underestimated the SD, the upper limit of the 95% confidence interval is 0.14.  With this SD we would 
need 19 subjects to detect this same effect.  
 
If we progress to a comparison between Kurbo vs. Kurbo + PHC, we will utilize a repeated measures 
model such as GEE or linear mixed models.  As we have no preliminary estimates of variability or 
correlation over time, we have estimated the sample required for a medium effect size  of 0.50  
(Cohen’s d, calculated as the difference between means divided by the pooled standard deviation) 
assuming a two-sided alpha of 0.05, power of 0.80 and 4 repeated measures with a correlation of 0.3.  In 
this case, we would need to sample balanced groups of approximately 28 each.  If the correlation 
increases (e.g. 0.5 or 0.7) power will increase. 
 
 
Based on the above information, in addition to adding ~20% for possible study withdrawal, we wish to 
recruit a total of 35 subjects in each Kurbo group for a total sample size of 70 subjects.  This sample size 
should allow us to assess clinically relevant outcomes with sufficient power.  
 
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
Risks and Benefits 
 
The greatest risk is loss of confidentiality. In order to minimize risks, we are implementing the data 
security plan outlined below.  The benefits of using the program include potential weight and BMI loss 
as well as increasing education on healthy food and exercise choices.  
 
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
Data Security and Confidentiality 
 
Data will be held within a Tufts REDCap database, which is accessed only by the statistician, research 
coordinator and principal investigator. All HIPAA identifiers will be tagged and download access will be 
restricted to coded data for users. Any required dates will be date shifted using the REDCap date shifting 
algorithm.  All email communications between study personnel will be conducted using Baystate email 
accounts.  Coupon codes will be provided to the RC by Kurbo so that purchase of the PHC can be 
accomplished. 
 
 
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
Significance and Innovation 
 
Children are not considered ‘little adults’ with regard to health and wellness. Therefore, we cannot 
assume that interventions that have been studied in adults will have the same outcome in adolescents 
and children. Studies have assessed the use of weight loss apps in adults and have found successful 
weight loss can be achieved with their use. However, such apps are not designed for use in the pediatric 
population, where the important balance of sufficient intake to grow vertically while not growing 
horizontally needs to be achieved for success. Kurbo is an app that is targeting this population and if 
validated by a pediatric weight loss clinic, could become an essential adjunct to weight loss programs 
around the country.  
 
In addition, the tool is free, while the added dietitian support requires a nominal fee that is not more 
expensive than the cost of additions to other free apps or online weight loss programs for adults. These 
tools could be easily obtained by adolescents and children looking for guidance in achieving a healthy 
weight. Should results be positive and indicate significant improvements in BMI z-score, our next step 
would be to utilize the app and personal health coach features in a larger group of children and 
adolescents, whereby we will also be able to assess changes in comorbidities of obesity, including 
hypertension, pre-diabetes, hyperlipidemia, non-alcoholic fatty liver disease and insulin resistance.  
 
 
 
 
 
 
 

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A Pilot Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight 
Loss App 
Clinical Trials ID NCT02880254 
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