Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
Phase: NA
Conditions: Obesity
Sponsor: Children's Hospital Medical Center, Cincinnati

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INNOVATIONS IN MANAGEMENT OF OBESITY AND INACTIVITY IN PEDIATRIC 
PRIMARY CARE 
 
APPLICATION FOR STUDY  
***SUBMITTED FOR EXPEDITED REVIEW*** 
 
Kristen Copeland, MD (Principal Investigator) 
Courtney Brown, MD, MSc (Co-Investigator) 
Monica Mitchell, PhD (Co-Investigator) 
Robert Siegel, MD (Co-Investigator) 
Christopher Bolling, MD (Co-Investigator) 
Heidi Sucharew, PhD (Biostatistician) 
Research assistant – TBN -  
 
 
 
 
 
 
 
 
 
 
 
Division of General and Community Pediatrics 
Cincinnati Children’s Hospital Medical Center 
3333 Burnet Ave., ML 2011 
Cincinnati, OH 45229 
Phone: 513- 636-8354 
 
Division of Behavioral Medicine & Clinical Psychology 
Cincinnati Children’s Hospital Medical Center 
3333 Burnet Ave., ML 2011 
Cincinnati, OH 45229 
Phone: 513- 636-4336 
 
Center for Better Health and Nutrition 
Cincinnati Children’s Hospital Medical Center 
3333 Burnet Ave., ML 2011 
Cincinnati, OH 45229 
Phone: 513- 636-4305 
 
 
Text
NCT # 02724839
Date: 08-17-18

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BACKGROUND 
 
Obesity is an increasingly common condition of childhood (18% of all US 6-11 year olds, 
24% of black children)1 that has both acute and long-term adverse effects—depressed 
mood and academic achievement, diabetes, stroke, and premature death.2-4 Obesity is 
particularly challenging to treat or prevent because it involves changing two essential 
health behaviors part of daily life: diet and exercise.5 These behaviors lie squarely within 
the domain of pediatrics and preventive health; school-aged children visit their primary-
care doctor annually. Thus public health experts in obesity have called for innovations in 
primary care to address them.4,6-9 Yet effective means to prevent, identify, and treat 
obesity or inactivity within primary care are lacking;4 and several research interventions 
have had only modest effects, even with one-on-one family-centered counseling 
methods.10,11  
 
Within the context of a 20-minute well-child check, with competing patient-related 
medical and behavioral needs, it is exceedingly difficult to counsel effectively about a 
patient’s diet or to effectively promote physical activity.12 Yet this is the expectation and 
standard of care for overweight/obese patients. The Pediatric Primary Care Clinic 
(PPC), cares for 1100 overweight/obese children aged 6-11 years (37% of the PPC 
school-aged population of 3100) annually. The two options for PPC patients are to bring 
the patient back for a one-month follow-up visit to check progress on diet and exercise 
goals (no-show rate 60-70%), or to refer to an outside intensive weight-management 
program, Healthworks!. Only 14% of patients who are referred to Healthworks! make it 
to an initial appointment within 60 days, and only half of those continue in the program 
after the initial visit. What primary care lacks is a system to activate patients to make 
healthy changes in diet and exercise and to support patients when they inevitably 
encounter barriers, particular low-income families that experience food insecurity and 
lack safe places to be active.  
 
Furthermore, there is no opportunity in the PPC to allow patients/peers from the same 
neighborhood and/or from similar financial and cultural circumstances to share 
“practical tips”—relevant and neighborhood-specific knowledge about good places to 

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purchase fresh fruits/vegetables and safe parks to visit, or tips about making meals for 
picky eaters on a tight budget as a single parent. In Europe, group-based counseling 
programs connected to primary care have been used to effectively curb overweight 
among school-aged children.13,14  We hypothesize that peer-facilitated group sessions 
about nutrition behaviors, where patients from similar neighborhoods will connect 
socially and share barriers and successes, will similarly activate patients to make 
nutritional changes. 
 
In addition to peer-led nutrition groups, we intend to use Fitbit Flex devices for this 
study. The Fitbit Flex device, when worn on the right wrist, was found to reasonably and 
reliably estimate step counts (compared to video observations on a treadmill) and 
energy expenditure (compared to indirect calorimetry) during walking and running 
among 10 adult males in a study accepted for publication in the International Journal of 
Cardiology (Diaz, KM et al., accepted March 2, 2015). Although there are no published 
studies in children, Fitbit devices are the most commonly used consumer-grade 
pedometers/accelerometers in adult and pediatric research studies, including a 
feasibility RCT (Clinicaltrials.gov # NCT02031185) among 14-18 year olds at Seattle 
Children’s Hospital (Jason Mendoza, MD MPH). Fitbit devices can sync wirelessly via 
Bluetooth with all major mobile phone carriers with a free app, with laptop computers 
with the free app and Bluetooth capability, and with computers via a USB dongle that 
comes with the device. The devices can store activity data at epochs of one minute, 
hour, or by day; and for up to one week, two weeks, or one month, respectively, before 
needing to be synced. Through the free app, the devices also allow participants to share 
their activity levels with their friends and challenge each other. The Fitabase software 
allows researchers to track activity levels of all research participants, and can produce 
CSV data for excel spreadsheets for analysis, as well as heat maps, charts and 
displays. It also allows researchers to track participants’ syncs, thus enabling the 
research team to remind the participant to sync if it has been a while. At CCHMC, 
Kimberlee Bernstein (CRC, Gastroenterology) is using currently using Fitbits and 
Fitabase for an ongoing study (R01, Stavra Xanthakos), and has been impressed with 

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its functionality.  We hypothesize that giving parent and child dyads a Fitbit and the 
Fitbit app will activate parents and children to increase physical activities.  
 
We propose in this application to deploy evidence-based strategies that have already 
been tested in other settings. Our goal herein is to adapt and tailor them to the PPC 
population—to design and pilot an intervention that involves group-based nutritional 
coaching and the Fitbit and to collect the necessary preliminary data and experience to 
test the intervention in a larger trial. 
 
PURPOSE OF STUDY 
 
Hypothesis: We hypothesize that giving parent and child dyads a Fitbit and the Fitbit app 
will activate parents and children to increase their physical activity. We hypothesize that 
peer-facilitated group sessions about nutrition behaviors, where patients from similar 
neighborhoods will connect socially and share barriers and successes, will similarly 
activate patients to make nutritional changes (Aim 1). Additionally, we expect an 
improvement pre-post in physical activity levels, self-efficacy and intentions for physical 
activity, self-reported consumption of fruits, vegetables, and child quality of life, and a 
decrease in consumption of sugar-sweetened beverages and fast and junk-food (Aim 3). 
 
We will address this overarching hypothesis with the following Specific Aims: 
 
Specific Aims: 
1. Adapt existing proven interventions—group nutrition sessions and Fitbit-- with 
patient and community stakeholder input, to identify the most promising 
approaches (Phase 0).    
 
2. Pilot the nutrition sessions and Fitbit intervention for feasibility and acceptability 
(Phase 1). 
 
3. Evaluate the intervention for efficacy through the an interrupted time series using 
groups meeting bi-weekly (Phase 2) and groups meeting monthly (Phase 3). 

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Specific Aim 1 
 
The goal of the design phase is to collect stakeholder input on evidence-based 
strategies for promoting nutrition and physical activity and design them to meet the real-
world needs and circumstances of patients, families, and communities. We will primarily 
focus on designing the group-based nutrition support groups—to understand what 
content PPC families want and what format would work best, as the Fitbit device is 
already a popular consumer device and is used in many research studies to increase 
physical activity. This aim will be accomplished through four parts: (1) an environmental 
scan, (2) PI interviews with community stakeholders, (3) focus groups and interviews 
with PPC parents, and (4) design team meetings. We have already started steps 1 & 2, 
and begun assembling the design team during the development of this application. 
 
The environmental scan will be of existent group-based programs in primary care and 
obesity clinics nationally. We will continue literature reviews15-17 and draw on the 
substantial expertise of this proposal’s team of researchers in obesity and community 
engagement and innovators in primary care redesign to identify and select candidate 
programs. We will also contact the authors of the European studies13,14 for 
generalizable learnings. We will conduct Skype or phone interviews, and expect visits to 
one or two sites, with input and final selections made by the proposal team. The PI will 
also interview relevant community stakeholders (e.g., Gabriel’s Place, the Nutrition 
Council, school health personnel, the YMCA, Cincinnati Parks, and the Cincinnati 
Recreation Commission) to assess potential partnerships for Aim 1 design work and/or 
participation in group sessions for delivery of nutritional or activity content for Aim 2 & 3. 
 
 
 
DURATION 

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This project is planned to span 2 years.  Phase 0 & 1 will be conducted during Year 1.  
Phase 2 & 3 will be conducted during Year 2. 
 
 
POTENTIAL BENEFITS  
 
There are no potential direct benefits for participants in Aim 1. Benefits to others for 
information gleaned from Aim 1 are contributions to designing a system that better meets 
patients’ needs for activity promotion and dietary guidance. Participants in Aims 2 and 3 
may benefit by receiving practical tips of how to improve their diet, where to shop for 
inexpensive fruits and vegetables, and where are safe and fun parks to play in.  
 
 
POTENTIAL RISKS, DISCOMFORTS AND INCONVENIENCES 
 
The potential risks of this study are minimal, primarily loss of confidentiality. We will use 
unique IDs to separate any identifying information from the data collected for this study. 
Participants will be able to opt out of any part of the study that makes them feel 
uncomfortable. As a pilot study, we will be cautious and attentive to any aspects of this 
study that make participants uncomfortable that we did not anticipate. 
 
 
RISK/BENEFIT ANALYSIS 
 
Given the minimal risks and potential benefits of identification and discussion of improved 
knowledge and guidance strategies, combined with the potential benefits of improved 
health, the benefits outweigh the risks. 
 
INFORMED CONSENT AND ASSENT 
 
All study staff having direct contact with study participants will be trained in the ethical 
conduct of research including the process for obtaining informed consent. We request a 
waiver of documentation of consent for focus group and interview participants in Aim 1 as 
the consent document would be the only piece of identifiable information collected. 

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Written informed consent will be obtained from all participants for Aims 2 and 3.  
We will also collect a separate consent form giving permission for the study team to use 
photographs, audio recordings, and video recordings of participants to aid in the 
dissemination of the research methods. Participants who decline to give this secondary 
consent will not have photographs, audio recordings, or video recordings of them made. 
If such recordings are made accidentally they will be deleted as soon as the error is 
discovered. Participants would not be notified in such an instance. 
 
 
COMPENSATION 
Participants will be paid $10 for attending a nutrition group session, $10 for first upload 
of their child’s data to the Fitbit website or app, $10 at the completion of the pilot phase 
of the study.  Participants in the intervention phases will receive $15 or a t-shirt upon 
finishing the study.  Additionally, the Fitbit devices used by participants will be theirs to 
keep. 
 
METHODS 
Study Design and Rationale 
 
Specific Aim 1: 1. Adapt existing proven interventions—group nutrition sessions 
and Fitbit-- with patient and community stakeholder input, to identify the most 
promising approaches (Phase 0). 
 
Qualitative feedback about what content and format patients desire for nutrition group 
sessions will be collected in Aim 1. Written or audio transcripts of focus groups and 
interviews will be reviewed by Drs. Brown, Copeland, and Mitchell only. Summary 
results from these transcripts will be shared with the larger design team, including Drs. 
Brown, Copeland, Mitchell, Siegel, members of the the PPC Obesity task force (social 
worker, dietician, medical assistants and staff physicians), community partners (e.g., 
Myrita Craig) and PPC patient champions There will be no identifiable data in this 
summative results reviewed by the design team. 
 

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Specific Aim 2: Pilot the nutrition sessions and Fitbit intervention for feasibility and 
acceptability (Phase 1). 
 
The results of patient surveys regarding satisfaction with the Fitbit intervention and the 
group sessions in Aim 2 will be collected, de-identified, and shared with the design team. 
The Fitbit Flex device, when worn on the right wrist, was found to reasonably and reliably 
estimate step counts (compared to video observations on a treadmill) and energy 
expenditure (compared to indirect calorimetry) during walking and running among 10 
adult males in a study accepted for publication in the International Journal of Cardiology 
(Diaz KM et al, accepted March 2, 2015). Participants can choose to share activity levels 
with friends and each other. Fitbit tracks physical activity and participants’ syncs, and can 
provide CSV data for Excel spreadsheets for analysis, as well as, heat maps, charts and 
displays. We will also pilot a co-facilitation model utilizing a parent leader paired with a 
community professional with nutrition or health expertise to lead the group nutrition 
sessions. If successful, this model will be implemented in phases 2 and 3 as well. 
Additionally, we will collect surveys from the parents relating to their own depression, 
social support, and perceived stress pre- and post-intervention. These include the 
Parenting Stress Index - Fourth Edition-Short Form18, the Perceived Stress Scale19, the 
Patient Health Questionnaire20, and the Multidimensional Scale of Perceived Social 
Support21 These questionnaires will be piloted for feasibility of administration and possibly 
included in phases 2 and 3. 
 
 
Specific Aim 3: 3. Evaluate the intervention for efficacy through the an interrupted 
time series using groups meeting bi-weekly (Phase 2) and groups meeting monthly 
(Phase 3). 
 
In Aim 3, parents will report their child’s activity levels and child’s quality of life as 
measured by the PedsQL at baseline, midpoint, and at the end of the study; Children will 
report their self-efficacy and intentions for physical activity at baseline, and at the end of 
the study.. Parents will also report on 5 measures of their own and their child’s diet and 
sedentary habits 12 times during the group sessions and at least four time points in the 
following 2 months after the groups sessions are complete: 1) number of sugar-
sweetened beverages consumed by the child on previous day, 2) number of servings of 

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fruits and vegetables consumed by the child on that day, and 3) number of hours of 
TV/screen time 4) number of meals/snacks with fast food, 5) number of servings of snack 
food. To establish baseline control limits for each subject individually, and an average of 
the group collectively, we will also ask parents to report these same 3 outcomes on 10 
randomly sampled and non-continuous days (7 times on a weekday and 3 times on a 
weekend day) during the month prior to the first session.  We will query parents via email, 
phone calls and/or texts, per their preference. (While more baseline data points are 
desirable, we are concerned about the participant burden involved with collecting more 
data points. During the pilot phase, we will experiment with texting to collect outcome data 
from patients.  If it appears feasible to collect data more frequently, we will consider 
collecting more than 7 baseline data points from some or all participants.). We will use 
Fitabase software to track the child’s (and parent’s) physical activity level over the course 
of the 3 month trial, and for up to 3 months after the trial ends. We plan to use the initial 
week of Fitbit use as the baseline of the participant’s physical activity level, recognizing 
the limitations that giving patients a device to measure their physical activity may 
encourage them to increase it from its true baseline. We will also collect information about 
food allergies, dietary restrictions, and most frequently shopped grocery stores via 
questionnaire once at the beginning of the study. 
All data will be seen and analyzed only by the study personnel. A trained research 
assistant will collect height and weight measurements for both the parent and the child in 
triplicate (measured to the neariest 1.0cm and 0.1kg) with portable stadiometers and high-
precision scales at 0, 3 and 6 months Child participants will be assigned a unique ID. Any 
children’s names that are used on forms for tracking purposes will be blacked out and 
replaced with the unique ID. As they are collected, paper forms will be kept in a file box 
that study staff will keep with them at all times. After collected, paper forms will be stored 
in a locked file cabinet at CCHMC. All data will be entered into password-protected 
CCHMC electronic database. Only study personnel will have access to the data and all 
will have completed HIPAA and research ethics participation. All data collection and 
storage procedures will be reviewed by the CCHMC IRB for their compliance with HIPAA 
regulations. 
 

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Another source of qualitative data will be “practical tips” that participants share at 
nutrition sessions. Nutrition group sessions cannot be blinded, and the intention of these 
sessions is to develop connection and emotional support among participants. No 
sensitive information will be asked or collected at these sessions; participants will share 
only what they feel comfortable sharing. Running concurrently with the adult group 
nutrition sessions, the children will have general nutrition and exercise content delivered 
through the childcare provider for each session. The purpose, format, and content of 
these group sessions will be thoroughly explained during the consent process for Aims 
2 and 3. 
 
Study Site 
The Pediatric Primary Care Clinic (PPC) at Cincinnati Children’s Hospital Medical 
Center (CCHMC).   Additionally, Gabriel’s House in Avondale will be utilized (see letter) 
as an alternate location. 
 
 
Data Collection 
Specific Aim 1:   
Focus groups will be moderated by Dr. Mitchell or her designee and attended by the PI; 
the PI will conduct parent interviews. The goal of both is to understand what nutritional 
coaching PPC families want or need (e.g. meal planning, tips for purchasing 
inexpensive healthy foods, tips for increasing vegetable consumption); how they want it 
delivered (e.g., didactic vs. facilitated group discussion); whom they would like to deliver 
the content (e.g., health professional, community health worker, peer); and where they 
would want it delivered (e.g., at CCHMC vs. Gabriel’s Place). We will present examples 
of group-based nutritional coaching and peer support programs and will ask families to 
react and suggest changes. Interviews and focus groups will focus on user-centered 
design, to understand what people think and feel (e.g., about a new proposed process 
or design), rather than traditional research focus groups that dissect what people say 
and do (e.g., to identify benefits and barriers to a health behavior).22-24 We will also 
solicit PPC families’ input on the Fitbit intervention to identify potential problems to 
mitigate them for the next phase, but we expect necessary adaptions to be minimal. A 
key outcome of Aim 1 will be the identification of 2-5 PPC “champions” We envision that 

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these “champions” will likely be PPC parents who are improving their own diets and 
exercise and have made changes in their household to improve her children’s diet and 
exercise opportunities. We plan to engage this pool of “champions” as candidates to 
lead group sessions in Aim 2 & 3, assist with recruitment for Aims 1-3, and participate 
on the design team of Aim 1. 
 
Specific Aim 2: 
We will conduct a small pilot of 4 group sessions and the Fitbit intervention for the 
parent-child dyads. The rationale for this pilot is to give peer-leaders a chance to 
practice leading group sessions and to work out any bugs in the interventions planned 
for Aim 3. (For instance, patients may bring other siblings to sessions thus we will need 
to practice offering child-care arrangements vs. involving these siblings in sessions.) 
Fitbit devices are the most commonly used consumer-grade 
pedometers/accelerometers in adult and pediatric research studies, including a 
feasibility RCT (Clinicaltrials.gov # NCT02031185) among 14-18 year olds at Seattle 
Children’s Hospital (Jason Mendoza, MD MPH). At CCHMC, Kimberlee Bernstein 
(CRC, Gastroenterology) is currently using Fitbits and Fitabase for an ongoing study 
(R01, Stavra Xanthakos), and has been impressed with its functionality. The device 
connects through USB port or Bluethooth technology to all mobile devices. Thus the 
purpose of the Fitbit pilot will primarily be to orient the CCHMC team to Fitabase 
capabilities, how to interact with patients about results, and interfacing with the Fitbit 
team to optimize its deployment for PPC patients. Through 4 group sessions we will 
have the opportunity trial sessions at CCHMC vs. Gabriel’s Place (see letter) and 
sessions that are parent-only vs. parent-and-child-combined, to see which participants 
prefer and which works best. We considered, and rejected, a factorial design to test 
these factors due to the need to recruit a large number (>80) of independent subjects. 
For this study, power analysis is not applicable since in an interrupted time series the 
participants are examined on an individual level not as a whole. 
 
CONTENT/FORMAT OF SESSIONS- As per design principles, we will remain flexible in our 
preconception of the final intervention, but we expect group sessions to involve both 

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parents and children (split into smaller groups as necessary) and to consist of four parts: 
(1) a facilitated 20 minute discussion of barriers and successes25 related to healthy eating 
,(2) a brief, interactive teaching session about healthy eating, (3) a review of Fitbit results 
(at the group level) and a discussion of successes and problems with the program for 
PPC patients, and (4) a healthy meal. The facilitated discussion will operate similar to 
group therapy,26 building relatedness and competence27 among participants as they see 
peers facing similar barriers. We expect patient to find inherent value in the connection 
gained through discussion, which will aid in retention for subsequent sessions. We also 
expect to gain informal insights and practical tips from the successes that parents share, 
e.g., planting a window box garden and successfully inciting their child to taste new 
vegetables grown at home. The brief teaching session will focus on practical, 
implementable strategies (e.g., MyPlate strategies of filling half the plate with fruits and 
vegetables, how to deal with picky eaters) to be delivered in simple terms by community 
partners (see Myrita Craig letter) or residents/ nutrition students. Outcomes (1) 
attendance at group sessions, and (2) satisfaction with each the group session. We will 
work with the design team to make necessary refinements prior to the efficacy trial in Aim 
3. 
 
Specific Aim 3: 
We plan an interrupted times series. To maximize participation in group sessions, we 
will split the nutrition arms into two groups. We anticipate a 67% show rate in each 
group.28 Dividing the nutrition counseling sessions into two groups allows the respective 
groups to self-sort according to convenience factors such as neighborhood (e.g., 
Avondale, Price Hill, etc.) and preferred time (afternoon or evening).  
We will track the following outcomes for Aim 3 beginning at the first session (baseline), 
at each group nutrition session, and at least 2 time points afterwards: (1) attendance at 
session, (2) satisfaction with session; self-reported consumption on prior day of (3) fruits 
and vegetables, (4) sugar-sweetened beverages, (5) fast food and (6) snack-food; and 
(7) TV/screen time used. Additionally, we will track (1) child self-efficacy and intention to 
be physically active,29 (2) child quality of life as measured by the PedsQL.30 We will also 
track satisfaction with the group sessions. Although not a primary outcome that we 

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would expect to change given the modest intensity of this intervention, we will also track 
child BMI 0, 3 months, and 6 months. We will track participants’ physical activity levels 
over one week as measured by the Fitbit device, which is highly accurate and reliable 
when compared to research-caliber accelerometers (Diaz, KM et al., accepted March 2, 
2015). Finally, we will track lost-to-follow-up and no-shows, by making a strong effort to 
re-contact families to obtain information on reasons for not participating. 
 
Training of Study Personnel  
Dr. Mitchell and CCTST Engagement Core resources will train the PPC champions to be 
group facilitators for nutrition sessions (Feb 2016) and retrain as necessary (May, Aug 
2016). Dr. Mitchell has experience in this area through directing Community Leadership 
Institute, which builds capacity of non-profit community agency professionals. This “train 
the trainer” model builds capacity of community resources and will be more sustainable 
than a model that relies on CCHMC staff or personnel to facilitate sessions and/or deliver 
content. Trained peer facilitators will receive $40 and a healthy meal for each session 
facilitated.  Additionally, all study staff having direct contact with study participants will be 
trained in the ethical conduct of research including the process for obtaining informed 
consent. 
 
Study Population (inclusion/exclusion criteria) 
 
Aim 1: We will recruit approximately 100 parents of children aged 6-11 years whose 
medical home is the PPC (N=18,000 patients) and whose BMI is greater than the 85th 
percentile for age and sex (n=1100 patients) to participate in either focus groups or one-
on-one interviews for Aim 1.  Fliers will be placed prominently in clinic and subjects will 
be recruited at well-child checks or ill visits by attending physicians associated with this 
proposal and /or the research assistant who will staff the clinic and approach potentially 
eligible families during downtimes in their clinic visit. We will use PPC electronic medical 
record (EPIC) to identify PPC patients aged 6-11 years old who have been identified or 
measured as being overweight per clinic records. They already have a relationship with 
the PPC as the PPC is their primary medical home. We will use the most recent contact 
information in EPIC to recruit via telephone and mailed letters (see attached letters). We 

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believe we will have no difficulty recruiting 100 patients out of the 1100 potentially 
eligible patients, but will adjust recruitment strategies, including additional staffing hours 
of the research assistant, if necessary. There will be a study phone number that 
potentially interested subjects will call which will be staffed by the research assistant. 
We will also encourage participants to recruit their friends and peers who are also PPC 
patients to call the study phone number.  
 
Subjects that participate in Aim 1 will be eligible to participate in the pilot for Aim 2 or the 
interrupted time series for Aim 3. At the conclusion of their interview/focus group, they 
will be asked if they wish to participate in future research related to the topic including a 
clinical trial, and if so 3 forms of contact will be recorded (e.g., cell phone, home phone, 
and email address). We will recruit up to 25-30 children aged 6-12 years whose BMI is 
greater than 85th percentile for age and sex, and their parents to participate in the pilot 
for Aim 2.  
 
Additional inclusion criteria include: both parent and child interested in making 
nutritional and/or physical activity changes, and agree to participate in at least 4 group 
sessions and trialing the Fitbit intervention. Exclusion criteria for Aim 2 are as follows: 
participation in Healthworks! Weight management clinic in the past two years; child has 
a current prescription for an atypical anti-psychotic medication (because weight gain is a 
common side effect with these medications); parent does not have access to either a 
smartphone or a computer at home (as they would be unable to easily sync Fitbit data). 
The same criteria will be used to recruit up to 100 patients and parents dyads for Aim 3. 
To minimize contamination, subjects that participate in Aim 2 will not be eligible to 
participate in Aim 3. In addition to contacting interested participants from Aim 1, we will 
continue to recruit for Aims 2 and 3 through attending physicians, the research 
assistant, fliers, and the study phone line. We expect these recruitment strategies to be 
sufficient to recruit 100 patient-parent dyads over 9 months, but will adjust strategies if 
necessary. Retention for Aim 3 is one of the outcomes we will measure for this efficacy 
trial and pilot. 
 

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Inclusion of Women and Minorities  
No racial, ethnic, or gender group will be excluded from participation in the study. Our 
patient population is approximately 60% African-American, 85% Medicaid, and 10% 
self-pay. We expect the parents that want to make diet and activity changes for 
themselves and their families for Aims 2 and 3 will primarily be women, but men will not 
be excluded.  
 
Inclusion of Children 
Children are the primary subjects of the proposed study. Children aged 6-12 years old 
and who are >85th percentile for BMI for age and sex will be eligible. This age range 
was chosen because obesity represents a significant problem for this age group and 
this age group is still dependent on parents for selecting and preparing foods and 
snacks served at home. Moreover, this age group covers the elementary grades 
Kindergarten through 6th grade in Cincinnati, thus this age group is used to doing things 
together at elementary schools. The investigative team has ample experience working 
with this age group and their parents. The sample size of 100 patients for the efficacy 
trial in Aim 3 was selected to provide a sufficient number of children to contribute a 
meaningful analysis of the intervention’s effect on children’s nutrition and physical 
activity habits.  
 
 
Statistical Methods and Data Analysis 
Data analytic plan: 
Aim 1: Drs. Mitchell, Brown, and Copeland, who each have experience with 
ethnographic methods, will review transcripts of focus groups and interviews for themes 
and suggestions. Results will be reviewed by a larger design team, to include Drs. 
Brown, Siegel, Bolling, members of the PPC Obesity Task Force (staff physicians, 
dietician, social worker), community agency partner(s), and 1-2 patient “champions,” 
identified from focus groups and interviews. Another important outcome is the bringing 
together of this cluster of accomplished researchers in different fields, clinicians, 
patients, and community members for design team work that builds capacity for future 

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grant applications. The design team will work collaboratively to plan the pilot group 
sessions for Aim 2 and make any necessary tweaks for Aim 3 efficacy trial. 
 
Aim 3:  
Individual- and group-level data for self-reported consumption outcomes (fruits and 
vegetables, sugar-sweetened beverages, fast food, snack-food, TV/screen time) and 
Fitbit-generated physical activity data will be plotted in time series on control charts.  
Statistical process control will be used to evaluate the impact of our interventions.  A 
centerline (mean) and control limits will be established using pre-intervention data.  The 
mean will be recalculated and the centerline adjusted when the following criteria are 
met: a “shift” of six or more consecutive points either above or below the mean or a 
“trend” of at least five consecutively increasing or decreasing data points.  These are 
considered statistically significant changes, as there is < 5% chance of observing these 
patterns by chance.31  In addition, individual data points falling outside the control limits 
are statistically unlikely to occur in the absence of a “special cause” and will be further 
examined for association with the intervention or other factors.32  
Data and Safety Monitoring Plan 
The data safety and monitoring plan for this low-risk study involves ongoing review of 
the research protocol, subject recruitment, data integrity and patient safety. The design 
team will meet monthly during Aims 2 and 3 to review recruitment, retention, and any 
adverse events. We will report any adverse events promptly to the IRB per CCHMC 
policies and procedures. We will also report study progress and any barriers to 
recruitment or retention to the PPC Obesity task force, which meets monthly. We 
proposed to enlist a Safety Officer from General and Community Pediatrics, who is not 
directly affiliated with this proposal, to whom we will submit reports on recruitment, 
retention, and performance information. A Safety Officer is proposed rather than a full 
Data Safety and Monitoring Board (DSMB) as this study carries low risk. A full DSMB 
will be developed should that be deemed necessary.  
 

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FUTURE USE 
 
There is a gap in the literature of effective ways to prevent, identify, and treat obesity or 
inactivity within primary care, particularly for low-income families at greatest risk for 
obesity and inactivity. This study is intended to design a primary care-based intervention 
for obese/overweight children that is patient/family-centered, group-based, and 
embedded in the community.   
 
 
PUBLICATION 
 
The authors plan to present and publish the outcomes of this study. 
 

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REFERENCES: 
 
1. 
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United 
States, 2011-2012. Jama 2014;311:806-14. 
2. 
Daniels SR. The consequences of childhood overweight and obesity. Future Child 2006;16:47-67. 
3. 
Daniels S. Complications of obesity in children and adolescents. International Journal of Obesity 
2009;33:S60-S5. 
4. 
Barlow SE, Expert C. Expert committee recommendations regarding the prevention, assessment, 
and treatment of child and adolescent overweight and obesity: summary report. Pediatrics 2007;120 
Suppl 4:S164-92. 
5. 
Rodgers GP, Collins FS. The next generation of obesity research: no time to waste. Jama 
2012;308:1095-6. 
6. 
Physical Activity Guidelines for Americans Midcourse Report Subcommittee of the President's 
Council on Fitness, Sports & Nutrition Washington, DC: US Department of Health Human Services,; 2012. 
7. 
Dietz WH, Gortmaker SL. Preventing obesity in children and adolescents 1. Annual review of 
public health 2001;22:337-53. 
8. 
Pratt CA, Stevens J, Daniels S. Childhood Obesity Prevention and Treatment: Recommendations 
for Future Research. American Journal of Preventive Medicine 2008;35:249-52. 
9. 
Davis MM, Gance-Cleveland B, Hassink S, Johnson R, Paradis G, Resnicow K. Recommendations 
for prevention of childhood obesity. Pediatrics 2007;120 Suppl 4:S229-53. 
10. 
Hughes AR, Stewart L, Chapple J, et al. Randomized, controlled trial of a best-practice 
individualized behavioral program for treatment of childhood overweight: Scottish Childhood 
Overweight Treatment Trial (SCOTT). Pediatrics 2008;121:e539-46. 
11. 
McCallum Z, Wake M, Gerner B, et al. Outcome data from the LEAP (Live, Eat and Play) trial: a 
randomized controlled trial of a primary care intervention for childhood overweight/mild obesity. Int J 
Obes (Lond) 2007;31:630-6. 
12. 
Klein JD, Sesselberg TS, Johnson MS, et al. Adoption of body mass index guidelines for screening 
and counseling in pediatric practice. Pediatrics 2010;125:265-72. 
13. 
Weigel C, Kokocinski K, Lederer P, Dotsch J, Rascher W, Knerr I. Childhood obesity: concept, 
feasibility, and interim results of a local group-based, long-term treatment program. Journal of nutrition 
education and behavior 2008;40:369-73. 
14. 
Kalavainen MP, Korppi MO, Nuutinen OM. Clinical efficacy of group-based treatment for 
childhood obesity compared with routinely given individual counseling. Int J Obes (Lond) 2007;31:1500-
8. 
15. 
Pérez-Escamilla R, Hromi-Fiedler A, Vega-López S, Bermúdez-Millán A, Segura-Pérez S. Impact of 
peer nutrition education on dietary behaviors and health outcomes among Latinos: a systematic 
literature review. Journal of nutrition education and behavior 2008;40:208-25. 
16. 
Chaudhary N, Kreiger N. Nutrition and Physical Activity Interventions For Low-Income 
Populations. Canadian Journal of Dietetic Practice and Research 2007;68:201-6. 
17. 
Pearson ML, Mattke S, Shaw R, Ridgely MS, Wiseman JSH. Patient Self-Management Support 
Programs: An Evaluation. Santa Monica, CA: RAND Health; 2007. 
18. 
Abidin RR. PSI-4 Parenting stress index. 1995. 
19. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and 
social behavior 1983:385-96. 
20. 
Kroenke K, Spitzer RL, Williams JB. The Phq-9. Journal of general internal medicine 2001;16:606-
13. 
21. 
Zimet GD, Dahlem NW, Zimet SG, Farley GK. The multidimensional scale of perceived social 
support. Journal of personality assessment 1988;52:30-41. 

19 
 
version 5 
 
22. 
Carman KL, Dardess P, Maurer M, et al. Patient and family engagement: a framework for 
understanding the elements and developing interventions and policies. Health affairs (Project Hope) 
2013;32:223-31. 
23. 
Seid M, Margolis PA, Opipari-Arrigan L. Engagement, peer production, and the learning 
healthcare system. JAMA pediatrics 2014;168:201-2. 
24. 
Fore D, Goldenhar LM, Margolis PA, Seid M. Using Goal-Directed Design to Create a Novel 
System for Improving Chronic Illness Care. JMIR research protocols 2013;2. 
25. 
Loren RE, Vaughn AJ, Langberg JM, et al. Effects of an 8-Session Behavioral Parent Training 
Group for Parents of Children With ADHD on Child Impairment and Parenting Confidence. Journal of 
attention disorders 2013. 
26. 
Renjilian DA, Perri MG, Nezu AM, McKelvey WF, Shermer RL, Anton SD. Individual versus group 
therapy for obesity: effects of matching participants to their treatment preferences. Journal of 
consulting and clinical psychology 2001;69:717-21. 
27. 
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social 
development, and well-being. American psychologist 2000;55:68. 
28. 
Stang J, Story M. Guidleines for Adolescent Nutrition Services. In: Stang J, Story M, 
eds.2005:Chapter 5, pages 55-61. 
29. 
Saunders RP, Pate RR, Felton G, et al. Development of questionnaires to measure psychosocial 
influences on children's physical activity. Prev Med 1997;26:241-7. 
30. 
Varni JW, Seid M, Kurtin PS. PedsQL™ 4.0: Reliability and validity of the Pediatric Quality of Life 
Inventory™ Version 4.0 Generic Core Scales in healthy and patient populations. Medical care 
2001;39:800-12. 
31. 
Perla RJ, Provost LP, Murray SK. The run chart: a simple analytical tool for learning from 
variation in healthcare processes. BMJ quality & safety 2011;20:46-51. 
32. 
Provost LP, Murray S. The health care data guide: learning from data for improvement: John 
Wiley & Sons; 2011.