Increased Monitoring of Physical Activity and Calories With Technology
Phase: NA
Conditions: Weight Change, Body, Behavior, Health, Obesity, Childhood, Parent-Child Relations
Sponsor: Wake Forest University Health Sciences

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Study Title: IMPACT: Increased Monitoring of Physical Activity and Calories with Technology 
 
Principal Investigator, Co-investigator(s): Dr. Justin Moore and Dr. Joseph Skelton 
 
Sponsor or funding source: National Institutes of Health  
 
NCT number: NCT03961061 

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Background, Rationale and Context 
 
Background: Since severe obesity in youth (BMI for age ≥120th percentile) has been steadily increasing, 
intensive clinical intervention is necessitated, which is often delivered in specialized pediatric obesity 
clinics. Since the home environment and parental behavioral modeling are two of the strongest predictors 
of child weight loss during behavioral weight loss interventions, a family-based treatment approach is 
warranted. This strategy has been moderately successful in our existing, evidence-based pediatric weight 
management program (Brenner FIT), but since programs such as Brenner FIT rely on face-to-face 
delivery of programmatic elements, the dose delivered is limited by the time constraints experienced by 
families enrolled in treatment. Therefore, the purpose of this study is to refine and pilot a tailored, mobile 
(mHealth) component to augment an existing, evidence-based pediatric weight management program 
(Brenner FIT) to determine acceptability from a patient and clinical staff perspective, feasibility, and 
economic costs relative to the established weight management protocol alone [i.e., Brenner FIT vs. 
Brenner FIT + mHealth (Brenner mFIT)]. 
 
 
Objectives 
 
Primary Aim 1: Finalize an intervention for adolescent youth with obesity, consisting of 
podcasts/videos and electronic self-monitoring, to promote reduced caloric intake and increase 
physical activity.  
 
Primary Aim 2: Pilot the intervention in dyads (n = 40) recruited from a pediatric weight loss 
clinic, to establish acceptability and feasibility of the intervention relative to standard care (n = 
40).  
 
Secondary Aim: To establish costs associated with development and implementation of mHealth 
components when delivered with the Brenner FIT program. 
 
Methods and Measures 
 
Design 
For this project, we will randomize 80 youth with obesity (13 – 18yrs) and a caregiver (dyads) to 
the Brenner FIT condition or the Brenner mFIT condition. All participants will complete baseline 
measures prior to randomization, and at three and six months. All youth participants will receive 
a commercially available activity monitor. Caregivers will receive podcasts with a story about a 
caregiver supporting weight loss in a child by providing healthy foods/activities for his/her 
family, including healthy eating and physical activity information. Children will receive animated 
videos that contain healthy eating and physical activity messaging, with an engaging story of a 
child losing weight. All participants will have access to a website and mobile apps where they 
will track weight, diet, and physical activity for themselves (youth) or their child (parents). Based 
on their reports of weight, eating, and physical activity, the messaging received from clinical staff 
by the families will be individually tailored to promote healthy behaviors and overcome 
perceived barriers. The proposed research is innovative in that it explicitly incorporates theory 
into the intervention and evaluation components of the project and builds upon an existing 
literature on mHealth interventions that use mobile technology. 
 
Setting 

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Brenner Children’s Hospital is a 160-bed, 400,000 sq. ft. children’s hospital, a part of Wake 
Forest Baptist Medical Center (WFBMC). This $132 million facility is the only children’s 
hospital in northwest North Carolina and has more than 30,000 pediatric visits each year. Brenner 
Children’s Hospital is one of only 51 Level I pediatric trauma centers in the country and one of 
only 3 in the state. Brenner is the only children’s hospital in western North Carolina and treats 
children from all bordering states. Brenner Children's Hospital is staffed by over 140 full-time 
pediatric faculty, and over 4,500 children are admitted to Brenner each year. Over 21,000 
pediatric subspecialty visits occur annually at outpatient clinics. Brenner Children’s Hospital is 
also home to specialty programs such as Brenner Families in Training (Brenner FIT). Brenner 
FIT, an interdisciplinary, family-based pediatric weight management program led by Co-
Investigator Joseph Skelton, MD, MS, is a premier program of Brenner Children’s Hospital. 1,2,3,4 
Brenner FIT is an evidence-based program that focuses on the treatment of obesity in children 
ages 2 to 18 who have a medical concern related to their weight. A physician referral is required, 
and treatment involves the entire family. The Brenner FIT team includes physicians, family 
counselors, dietitians, social workers, activity/play specialist and physical therapist. Brenner FIT 
is available for English and Spanish-speaking families. Brenner FIT also offers free nutrition and 
parenting classes to all members of the community. 
 
Subjects selection criteria 
Brenner FIT will serve as the base of the study and recruitment source and serves a diverse array of 
children: patients are majority female (58%) and self-identified as white/European American (45%), 
black/African American (40%), or another race (5%). Ethnically, eighteen percent are Hispanic/Latino. 
The average patient is clinically obese as indicated by BMI (35.9 +/- 8.6) and BMI z-score (2.6 +/- 0.5). 
Half of the patient population is in their teenage years (13-18yrs).  
 
• 
Inclusion Criteria 
Youth with obesity, 13 – 18yrs, and a caregiver 30 – 60yrs. Caregivers must live in the home 
with their youth participants. Participants must also have access to a smartphone or tablet. 
• 
Exclusion Criteria 
Adolescents under the age of 13 will be excluded. Caregivers, who are not between the ages 
of 30-60 years old will also be excluded. If participants do not have access to a smartphone or 
tablet, they will not be able to participate.   
• 
Sample Size 
80 dyads which consist of youth and caregiver pairs.  
 
 
 
 
 
 
 
 
 
 
 
 
Interventions and Interactions 
 
Conditions 
 
Control condition: Brenner FIT (ie, standard 
After referral, families attend an orientation, in 

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care) 
which they are then scheduled for an initial 
introductory 2-hour intake group session and 
cooking class; these occur within 2-4 weeks of the 
orientation. Monthly 1-hour long visits with the 
dietitian, counselor, and PA specialist are held for 6 
months, in which the child and caregiver see the 
pediatrician. During the 6 months of treatment, 
they attend 4 group classes, choosing from topics 
such as meal planning, PA, and parenting. 
Specialized visits with the PA specialist or dietician 
are scheduled as pertinent issues arise. Clinic visits 
include individualized goal setting (for behaviors 
family/clinician have jointly agreed to address), 
healthy eating and physical activity education, and 
behavioral counseling to implement changes at 
home. Motivational interviewing, modified by 
Brenner FIT for use with families, 5 is the key to 
treatment; family counselors are trained in 
cognitive behavioral therapy, parenting 
support/mindfulness, and employ these approaches 
to assist families in developing healthy habits. Self-
monitoring is part of the treatment, using hand-
written, paper diet and PA logs, completed by 
parents and children and returned to clinicians. 
Brenner FIT is successful in enrolling families into 
research studies, including African Americans and 
Latinos.6,7,8,9 Brenner FIT sees ~200 new 
patients/families per year; ~66% of those enrolled 
successfully lose weight. The children who are 
successful display a decrease in BMI z-score of 
0.07 to 0.1, with an average BMI z score decrease 
at 8 months of 0.11. A .1 - .15 decrease in BMI z-
score is linked with healthy changes in 
cardiometabolic biomarkers.10,11 
Intervention Brenner mFIT (Brenner FIT plus 
mHealth) will include all components of the 
standard Brenner FIT program and six mHealth 
components that are designed to target theoretically 
supported constructs 
Component 1: A mobile-enabled developed for the 
project and accessible via phone, tablet, or personal 
computer will serve as a central hub for the 
materials. Podcasts, animated videos, tracking 
summaries (for parent and child), goal setting, and 
clinical feedback will be delivered via the website 
utilizing an application program interface (API) 
that integrates data from the two commercial apps 
(MealLogger and Fitbit™) with data entered by 
participants. Data integration is detailed in a later 
section.  
 
Component 2: Tracking apps chosen by the study 
team after consultation from caregivers and patients 
in or formative and prior work will be utilized for 
dietary and physical activity self-monitoring. 
Caregivers and adolescents will be instructed to 

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download the MealLogger 
(https://www.meallogger.com/) and Fitbit™ 
(https://www.fitbit.com/) apps to their mobile 
devices, and adolescents will be given a Fitbit™ 
Zip® activity tracker which syncs with the Fitbit 
app. Mobile apps have been shown to facilitate 
increased self-monitoring,12 which supports 
tracking of progress on behavioral goals (a 
component of Brenner FIT) by youth and reporting 
to the caregiver and clinical team. Tracking app 
data will be integrated into the mobile-enabled 
website.  
 
Component 3: Caregiver podcasts will provide 
recommendations that will assist them in 
navigating their pediatric weight management 
journey. These easily accessible podcasts will help 
caregivers deal with the emotions that come with 
raising an adolescent in treatment for a medical 
condition (ie, obesity), provide strategies and 
encouragement to caregivers to help their 
adolescent build autonomy for healthy behaviors, 
engage in age/ability appropriate physical activity 
with their child, cook healthy family meals, and 
provide healthy snacks. Podcasts will also focus on 
positive communication, interactions, and 
challenges often encountered in parenting. Podcasts 
have been used successfully in two previous studies 
by the team,13,14 and target several constructs from 
Self-determination Theory and Social Cognitive 
Theory including: 1) outcome expectations, 2) self-
efficacy, 3) incentive motivation, and 4) autonomy 
support. Podcasts will be 5-10 minutes long each 
and downloadable via the mobile webpage. 
Caregivers will download and listen to one podcast 
each week in weeks 1-12. 
 
Component 4: A total of six videos will be 
developed based upon prior feedback from 
adolescents enrolled in the Brenner FIT program. 
Videos will be made available to the youth weekly 
for the first six weeks. These videos will depict 
various situations that participants may face as a 
part of a program like Brenner FIT. Each video will 
help them as they deal with the negative and 
positive emotions of their weight-loss journey, and 
the difficult social situations they find themselves 
engaged in. The stories and scenarios are informed 
by our formative work with adolescent patients and 
will contain elements of humor and drama, while 
targeting several constructs from Self-

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determination Theory and Social Cognitive Theory 
including: 1) observational learning, 2) outcome 
expectations, 3) autonomy, and 4) relatedness. Like 
the podcasts, the videos will be accessible from the 
mobile-enabled website and sharable via social 
media once released for viewing.  
 
 
Component 5: Participants will be encouraged to 
follow each other and a curated list of health 
professionals on MealLogger. These interactions 
will be encouraged during Brenner FIT group 
sessions. Our team has extensive experience with 
developing and evaluating social media messages 
for support during weight loss. In a previous weight 
loss intervention that used Facebook for social 
support, we found that messages that were framed 
as polls or requests for suggestions from the group 
garnered the most interaction.18  
 
Component 6: Tailored feedback will be provided 
by clinical staff based upon reports generated from 
self-monitoring data. Clinical staff will receive a 
weekly report for each adolescent patient that will 
be given a quick summary of the level of self-
monitoring, nutritional content of recorded meals, 
level of physical activity engaged in, and progress 
on behavioral/weight loss goals. Staff will then use 
this information to engage with dyads via face-to-
face meetings, direct texts, and emails to give 
feedback based upon behavioral progress, 
encouragement to engage in greater self-
monitoring, and/or theoretically informed messages 
to promote self-efficacy, positive outcome 
expectations, and self-regulatory behaviors. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Outcome Measure(s) 
 
 
 
Analytical Plan 
 
Youth Only Measures 
Physical Activity  
Physical activity data will be collected using ActiGraph™ accelerometers 
(Shalimar, FL) currently owned by the team. The accelerometers will be set to 
collect data in “raw” format and analyzed by converting the data to 1-second 
epochs to account for the intermittent and sporadic nature of children’s PA and to 
improve the ability to capture the transitory PA patterns of children. During each 
7-day data collection period, these monitors will be affixed to a strap on the 
subject’s non-dominant hand. This protocol is being employed in NHANES and 
has been used successfully in studies of PA.19-21 We will distill the cut points in a 
manner consistent with emerging research22 that allows for comparability with 
waist-based estimates.23,24 Participants will be instructed to wear the monitor 
continuously over the next 7 days except during bathing and sleeping. Participants 
will also be given activity logs with the monitors25 and small gifts to encourage 
compliance. Text messages will be sent on the first morning of monitoring and 
after the last day of monitoring to encourage compliance and timely monitor 
return. Once an accelerometer is received, data from the accelerometer will be 
downloaded using the manufacturer’s software and USB computer interface. We 
will reduce, clean, and process the accelerometer using custom scripts in Stata as 
in our previous studies. We have used these strategies effectively in community-
based data collection.26,27,28,29,30,31 The accelerometers will be initialized and set to 
record beginning at 5:00am the day following their distribution. This will provide 
7 days of data for analysis, from which we will extract four or more complete 

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(>10 hour) days. 
Diet 
To assess diet in participating youth, we will use NCI’s automated, self-
administered 24-hour dietary recall, the Automated Self-Administered 24-hour 
(ASA24®) dietary assessment tool (version: ASA24-2016) on three, non-
consecutive days (including one weekend day). The ASA24-2016 is available on 
both computers and mobile devices. All youth participants will complete one 
ASA24 at their baseline orientation, and at 3-month and 6-month follow-up office 
visits to encourage compliance while allowing youth and caregivers to ask 
questions and gain comfort with using the system. The project coordinator will 
contact participants within six days (on a randomly selected day) following the 
office visits to inform participants that they should complete the second/third 
dietary recall and will offer to conduct the recall over the phone if the youth need 
assistance (the ASA24 has been shown to perform equally well as a self-
administered or interviewer administered questionnaire).32,33 A series of follow-up 
reminder messages and/or phone calls will be made by the coordinator to 
encourage completion of the second/third of the two recalls if not completed 
within 24-hours following the first contact after the clinic visit. 
 
 
 
 
 
 
Caregiver and Youth Measures 
Psychosocial Variables  
We will assess family and individual (youth and caregiver) constructs to identify 
potential mediators or moderators of observed effects of the intervention; these 
will be incorporated into a future, larger trial. Brenner FIT uses Family Systems 
Theory as a guiding model to addressing child and parent behaviors within the 
context of their family,34,35 and presently uses a number of scales to assess 
families participating in Brenner FIT. Specifically, Brenner FIT families complete 
the Family Assessment Device General Functioning subscale (capturing family 
function),36,37 Olson's Family Communication Scale,38 perceived stress,39,40 self-
efficacy for physical activity,41,42 behavioral self-regulation,43,44,45 and health 
behaviors of the family (captured by a measure designed and tested specifically 
for families participating in weight management).46 In addition, we will administer 
scales to capture Social Cognitive Theory and Self-determination Theory 
constructs targeted by the intervention that are not captured as part of the intake 
process. These include outcome expectations, autonomy,47 autonomy support,48 
and relatedness. All psychosocial data will be collected at baseline (prior to 
randomization), at 3 months, and 6 months. Details regarding the variables 
collected, their theoretical rationale, and measurement instrument are presented in 
Table 2 (see Table 2 below this chart).  
Socio-demographic 
Variables and Weight 
Status 
We will collect parental report of the caregiver and youth participant’s age, sex, 
race, and ethnicity. Weight status of caregivers and youth will be quantified 
through calculation of BMI derived from measurement of height and weight at the 
intake and follow-up visits. Both height (±0.1 cm) and weight (±0.5 kg) will be 
recorded twice and values will be averaged to produce the final value using a 
Tanita® digital scale and a Seca® Height Rod (respectively). BMI will be 
calculated as kg /m2 . Height and weight will be measured without shoes in 
normal clothing. BMI z-score will be calculated using Centers for Disease Control 
and Prevention (CDC) growth charts. 
 
 
 
 

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Results will be analyzed initially using descriptive statistics.  Comparison between groups will be done 
using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables.  
Regression analysis will be performed to identify independent outcome predictors.  Other inferential 
statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
 
Children will be identified and recruited from the Brenner FIT pediatric obesity clinic. We will also work 
with primary care physicians in Pediatrics and Family Medicine clinics to refer new patients to Brenner 
FIT, and thus increase our pool of potential recruits. In addition, we will review medical records of 
current and newly referred patients for eligibility via EPIC. This includes looking at age, weight status, 
and language preference at a minimum for incoming patients on the schedules of Dr. Joseph Skelton, Dr. 
Gail Cohen, and the Brenner FIT team. Those deemed initially eligible will be informed of the study 
following their intake visit by Brenner FIT clinical staff. Those who express interest will get an in-person 
“warm handoff” to a research team member who will confirm eligibility, re-assess interest, and schedule 
an intake visit. At that visit, recruits will receive more information about the study and provide consent 
(adult) and assent (child). 
 
o Before recruitment for participation: There is limited ability to mask the conditions from 
the clinical staff or their assignment from the participants represents However, the 
independence of our research staff from the clinical staff should protect against any 
expectancy effects biasing our data and protect patience identity.  
 
o After recruitment for participation: To ensure confidentiality, each child will be assigned 
a numeric identifier, and this identifier (not a name) will be associated with each 
participant’s data. Data will be kept in secure computer files and file cabinets, and access 
will be limited to the PI, Co-Is, and project coordinator. 
 
o Any Protected Health Information collected from your child in this study that is 
maintained in the research records will be kept for at least six years after the study is 
finished. 

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Informed Consent 
Signed informed consent will be obtained from each subject by study staff at the Brenner FIT clinic or 
virtually, prior to completion of any assessments. 
 
Participant Interaction 
• 
In light of the COVID-19 pandemic, we are also attempting to reduce the amount of face-to-
face contact with program participants. We also propose giving participants the ability to 
complete post-consent assessments and follow-up outside of the clinic setting. The following 
steps will be taken for participants who opt to complete assessments at home: Participants 
will receive copies of the consent/assent forms to read before their visit with the physician 
• 
Following their meeting with the physician, they will be provided with physical copies to 
read and sign in the presence of study staff 
• 
Participants will be provided an accelerometer and receive baseline incentives for study staff. 
A WebEx appointment to complete the psychosocial assessments for the project will be sent 
to participants. Assessments must be completed within 24-hours after enrollment 
• 
Once we receive the accelerometer, participants will be randomized to 1 of 2 groups. 
Participants will then be sent the respective information regarding their group assignment and 
additional action items depending on their group randomization 
• 
For 3 and 6 month follow-up appointments, participants will receive a link to a WebEx 
invitation to meet with study staff virtually  
 
 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy 
and confidentiality, only a unique study identifier will appear on the data collection form.  Any 
collected patient identifying information corresponding to the unique study identifier will be 
maintained on a linkage file, store separately from the data.  The linkage file will be kept secure, with 
access limited to designated study personnel.  Following data collection subject identifying 
information will be destroyed three years after closure of the study via shredding and deletion of any 
electronic data consistent with data validation and study design, producing an anonymous analytical 
data set.  Data access will be limited to study staff.  Data and records will be kept locked and secured, 
with any computer data password protected.  No reference to any individual participant will appear in 
reports, presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
Our Data and Safety Monitoring Plan consists of several layers including ongoing monitoring by: the 
Principal Investigators, all study investigators and staff who have contact with the participant, and the 
Institutional Review Board of WFU Health Sciences, and an appointed medical safety officer. Prior to 
enrollment of participants, guidelines will be established for identifying adverse events and serious 
adverse events. The data received from participants will be kept confidential and will be identified 
with a unique code known only to the project coordinator and the PI. Paper records will be kept in 
locked file cabinets and any electronic data will be kept in secure computer files on the Wake Forest 
Baptist Medical Center server. The Data and Safety Monitoring Plan will be submitted to the IRB for 
approval prior to data collection. 
 

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First, we will hold bi-weekly meetings of all members of the study intervention team where we will 
review participants’ status. This meeting will be directed by Dr. Skelton (co-I). Second, Dr. Skelton 
will be providing medical oversight of the intervention. He will individually review each participant’s 
progress and medical history monthly. If a participant is observed to be in threatening health 
(regardless of whether it is related to the study or not) or describes an adverse event, his or her 
primary care provider will be notified. Dr. Skelton will also collaborate with Dr. Moore who will be 
providing oversight for the data management team to identify any concerns in the surveillance for 
adverse events. Third, all unanticipated problems and serious adverse events will be reported to the 
Institutional Review Board at WFU Health Sciences per institutional policy. A plan for regular 
ascertainment of adverse events will include monthly symptoms forms collected throughout the study 
at planned group and individual visits. 
 
Since the proposed project does not involve a multisite clinical trial involving an intervention that 
entails potential risk to the participants, a Data and Safety Monitoring Board (DSMB) is not required. 
However, to ensure participant safety, the PI will invite individuals not directly involved with the 
project to join a scientific review board (SRB) to review aspects of the project including; the research 
protocol, plans for data and safety monitoring, evaluating recruitment progress, participant risk versus 
benefit, and other factors that can affect the study outcome and risks to the participants. They will 
also make recommendations to the investigators and the WFSM Institutional Review Board 
concerning continuation or conclusion of the trial. In the past, such advisors have included the 
department chair, biomedical ethics experts, community members, and public school/childcare 
officials. A caregiver of a child previously treated at Brenner FIT, but whose child is not currently 
enrolled in the study or the clinic will be identified and recruited fort the SRB if at all possible. 
Ongoing quality control will include regular data verification and protocol compliance checks to be 
performed by the project directors and research assistants.  Research staff members will undergo CITI 
training at the Wake Forest Baptist Medical Center, as well as being trained on each task for which 
they are responsible. They will also perform quality control for others similarly engaged. The study 
team will meet weekly to discuss progress and problems of the project. 
 
While a DSMB is not required, for the purposed of this study, there will be a medical safety monitor 
at the suggestion of the National Institute of Diabetes and Digestive and Kidney Diseases. For this 
study, Gail Michelle Cohen, MD, MS will serve as the medical safety monitor. Dr. Cohen is an 
Associate Professor in Pediatrics at Wake Forest School of Medicine. As a process of the continuous 
monitoring, the medical safety office will receive a report every six months that will include the study 
objective, a narrative of progress to date, recruitment and retention, visit completion, intervention 
adherence, data form completion, and adverse events (including serious ones). An example of this 
report is included at the end of this protocol document.  
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB sponsor, appropriate government agency if appropriate, or medical safety officer. 
 
 
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new directions. Obesity reviews: an official journal of the International Association for the Study of 
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23. Chandler JL, Beets MW, Drenowatz C, et al. The Rosetta Stone for equating hip and wrist- based 
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Appendix 
Data and Safety Monitoring Report 
TITLE/Grant Number 
PI 
Reporting Period Dates 
 
Checklist for safety officer to complete after reviewing the report: 
 
1. Is participant recruitment and enrollment acceptable? 
 
2. Is the retention rate acceptable? 
 
3. Is the intervention visit completion /intervention adherence acceptable? (Any concerns with 
intervention adherence?) 
4. Is the data collection completion rate acceptable? (Any concerns with missing data?) 
5. Is the overall adverse event rate acceptable? (Any concerns with serious adverse events?) 
6. Are there any situations that have occurred in the trial since the last safety report that warrant 
a study investigator conference (If yes, please explain in the space below this checklist) 
 
 
7. Is there any need to communicate with XXXXXX IRBs and/or the NIDDK regarding data 
monitoring or safety of participants? (If yes, please explain in the space below this checklist) 
 
 
Explanations/Comments (if applicable): 
 
 
Recommendation of the Safety Monitor: 
 
 
 
 
 
Safety Monitor Signature 
 
 
 
 
 
 
 
 
Date 

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