W8Loss2Go: Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Pediatric Patients Referred to a Tertiary Care Center Weight Management Clinic
Phase: NA
Conditions: Obesity
Sponsor: Children's Hospital Los Angeles

PRETLOW STUDY PROTOCOL (v4.0: 4/17/17) 
 
PI: Alaina Vidmar 
Co-Investigators: Steven Mittelman, Robert Pretlow and Claudia Borzutsky 
Coordinator: Emily Millen 
 
 
Sponsor: Robert Pretlow, E-Health International. Contract is pending and will be added to the IRB at a 
later date 
 
Study Question: Can the W8 Loss2Go program be used as an effective intervention tool in selected 
children referred to a tertiary care weight management clinic? 
 
Study Title: W8 Loss2Go: Behavioral Weight Loss Intervention utilizing Mobile Health Technology in 
Pediatric Patients Referred to a Weight Management Clinic.   
 
Background and Rationale: About one in five 12-18 years olds in the U.S. are obese, despite the 
implementation of current evidence-based weight management strategies. Obesity is caused by excess 
caloric intake relative to energy expended. It has been theorized that overeating in some individuals 
may have addictive qualities, and that specific foods may have addictive potential for these people. But 
few weight management interventions have tested therapeutic techniques founded in addiction 
medicine principles to date.  Therefore, it remains unknown whether the use of tools gained from 
treatment of other addiction disorders (such as alcohol addiction and smoking cessation) could be a 
viable strategy for weight management. 
 
Intervention: We will test a recent mobile technology based (mHealth) behavioral weight loss 
intervention (W8Loss2Go), which is designed for children and adolescents, and uses an addiction model 
to promote a staged withdrawal from problem foods, snacking, and excessive amounts at meals. 
 
Primary outcome 
 
Anthropometry: 
  
(1) Height and weight will be measured at baseline and at program completion.  These 
measurements will be converted to BMI (kg/m2) and zBMI scores (using CDC growth charts).  A 
historical control group derived from EMPOWER clinic will provide a comparator. 
 
(2) Interim face-to-face weight measurements at q3-month time points during the study, at a CHLA 
clinic. 
 
Secondary outcomes 
 
(1) Yale Food Addiction Scale (Gearhardt, 2011) 
(2) Food responsiveness and emotional overeating as assessed by the Eating Behaviors 
Questionnaire (EBQ-Merlo, 2009), and success in identifying and withdrawing from “problem 
foods”, eliminating snacking, and reducing the amounts of foods consumed at home meals. 
Success in these areas will be determined by participant self-report, as well as data collected 
from within the App. 

Process evaluation  
 
(1) Reach   
Proportion of patients referred to EMPOWER meeting the food addiction eligibility criteria.   
Proportion of patients that declined, dropped out or completed the intervention.  The reasons 
for refusal and drop out. (Data collected by study personnel) 
 
(2) Fidelity 
Extent to which intervention was implemented as planned. To be measured by number of 
patients completing problem food withdrawal, snacking control, and withdrawal from excessive 
amounts at home meals.  (Data derived from app tracking) 
 
(3) Dose of intervention received  (exposure) 
Opinion on patient’s ability to understand and implement intervention.  Adherence to 
commitments made by patient. (Data collected from mentor by questionnaire) 
 
(4) Dose of intervention received (satisfaction) 
Overall opinion of patient of intervention (parent and child) 
Benefits and burden of intervention (parent and child) 
Usefulness experienced by patient (parent and child) 
Recommendation to others (parent and child) 
 
(5) Barriers 
The extent to which problems were encountered while applying intervention (Data collected 
from mentor) 
  
Study Population: Twenty obese 12-18 year old adolescents will be recruited from new patients 
referred to the CHLA EMPOWER Clinic. Recruitment will begin with a pilot of 2 patients followed for 60-
90 days before open enrollment begins. 
 
Controls: historical controls using EMPOWER patient 
 
These participants will be selected from new referrals to the EMPOWER clinic which have a 
 
negative score on the YFAS-c. Control participants will continue through the standard of care 
 
EMPOWER clinic which included monthly multidisciplinary team visits with Physician, Dietitian, 
 
Psychologist and Physical Therapies. Anthropometric measures including weight, height and BMI 
 
will be obtained at each visit.  
 
Participant Compensation: $300 will be given to the participant, in the form of AMAZON gift cards after 
returning the iPhone and all accessories in good working condition to the study investigators at the end 
of study period. 
 
Participant Eligibility 
 
Inclusion: 
1. Age 12-18 years 
2. Patients referred to EMPOWER   
3. Positive screen on the Yale Food Addiction Scale for Children (see below) 
4. Participants will not be leaving the country during the study period.  

 
Exclusion: 
1. Obesity co-morbidities including impaired glucose tolerance, impaired fasting glucose, 
diabetes, fatty liver with ALT>40, BP > 99th percentile for age, gender, and height 
2. Psychiatric illness including depression and anxiety disorder 
3. Known developmental delay 
4. Does not speak/read English 
 
Study Design/Procedures  
Initial Visit: 
1. YFAS-c: 
 
All new EMPOWER patients will be verbally consented in order to complete the Yale Food 
 
Addiction Scale for Children, a validated 25 item instrument. The YFAS will be administered by a 
 
trained interviewer to each patient. Patients are instructed to refer to the past 12 months. Food 
 
addiction can be diagnosed when at least three of the seven criteria are met and the criterion of 
 
a clinically significant impairment or distress is met. We will use a cutoff of two of the seven 
 
criteria. Patients with more than two positive criteria on the YFAS-C will be offered participation 
 
in the W8L2Go App study. 
2. Consent: 
 
Upon obtaining verbal and written consent to participate in the study participants parents/legal 
 
guardian will complete  the Eating Behaviors Questionnaire (EBQ- Merlo, 2009), which will be 
 
completed at initiation  and completion of the program. The EBQ comprises 20 items designed 
 
to measure the hypothesized symptoms of food addiction based on adaptations of DSM-IV 
 
criteria for substance abuse and dependence.  
 
3. Complete EMPOWER Visit: 
 
Subjects will complete their first EMPOWER clinic visit will include the regular EMPOWER team 
 
approach (including healthy diet and exercise instruction, psychological screening, and 
 
motivational interviewing).  
 
4. Meeting with Study Coordinator and Distribution of Supplies: 
 
They will meet with the study coordinator for distribution of the iPhones, app, body scale and  
 
 weigh in scale. Each participant will register with a password on his/her iPhone and fill in 
 
user information. Participants will weigh-in on a scale in a private area and enter weight data on 
 
their iPhones.  Investigators will go through each section of iPhone app and have participants 
 
enter data.  
 
 
Participants will be loaned an iPhone 5S and accessories (including protective case), with an 
 
AT&T service plan for the duration of the study that includes: unlimited texting, 3 GB of data, 
 
unlimited voice calls to and from other cell telephones, 700 voice call minutes for calls to and 
 
from landlines, unlimited night and weekend calls to and from landlines, International calls or 
 
texts including Canada are NOT allowed and not covered. Participants will return these phones 
 
at the completion of the study. Participants may already own a smart mobile phone and in this 
 
case they will have the app downloaded onto their phone.    
 
Study Period (~6 months):  
 
1. Enter app data DAILY, as requested by investigators. (Usually 510 minutes of time per day). 
 
2. Enter weight DAILY using the wireless scale provided to the participant. 

 
3. Weigh all foods at home meals with the wireless food scale provided as directed by 
 
investigators. 
 
4. Test all the app features as requested by mentors/investigators. 
 
5. Respond to mentor/investigator messages via app eRoom and voice messaging within 24 
 
hours.  
 
6. Participate in weekly phone conversations with the iPhone. These phone conversations will be 
 
audio recorded for analysis purposes and to ensure internal validity. The phone conversations 
 
will be transcribed. The mentor will utilize a participant specific script to ensure participant 
 
specific barriers are being addressed. These conversations will last approximately 15 minutes. 
 
7. For 10-12 weeks, participants will identify and list all their problem foods and then proceed 
 
through withdrawal from each food for a minimum of 10 days, one or two foods at a time. A 
 
variety of techniques (gross pictures, motivational tools, coping skills to avoid comfort eating 
 
and white noise) are available in the W8Loss2Go app to facilitate this withdrawal and the use of 
 
these will be tailored to the needs of participants. 
 
8. For 4-5 weeks, participants will work on eliminating snacking by picking one or more time 
 
periods of day when they will avoid snacking morning, afternoon, evening, or nighttime. Once 
 
they are able to avoid snacking during a time period for at least 10 days in a row, that period is 
 
designated “Incontrol,” and they can can then work on a second time period. Snacking 
 
elimination is the goal before starting amounts reduction at meals. 
 
9. For 4-5 weeks, the amount of food consumed will be addressed with the goal of reducing the 
 
amount of nonproblem foods. This will be achieved by participants cutting serving sizes, no 
 
second helpings, smaller plates, someone else serves plate, depleasurizing foods, 
 
weighing/measuring foods, stress reduction, relaxation techniques. Weight is closely monitored 
 
in this Phase and if weight is not dropping additional reductions in the amounts of food 
 
consumed is implemented.  
During the 6 months, participants will not return to the EMPOWER clinic for a comprehensive visit 
unless a specific medical need arises, such as symptoms of comorbid condition, participants will return 
to CHLA 3 months into the study for a weight check and face to face meeting with the mentors. This visit 
will take approximately 30 minutes.  
 
After the 6 month period, participants will return to the clinic for a final weigh in. At this visit, the 
participants will return the iPhones (if one was loaned) and both wireless scales. The participant’s 
parent/legal guardian will also complete the EBQ questionnaire. This visit will last approximately 30 
minutes. After completion of the program participants will be offered return to EMPOWER clinic for 
further follow up if desired. 
 
6 months after completion of the study participants will return to clinic for a follow up weigh in.  
 
Follow-up:  
 
After completion of the program participants will be offered  to continue follow up in the 
 
EMPWOER clinic if desired.  
 
The iPhone app will be securely integrated with a network server for real-time data access and storage. 
All participant app data will be periodically backed up to a secure server to preserve data in the event 
the participant loses or damages his/her iPhone.   The investigators will have ongoing access to this data 
in order to monitor proper use of the app and participant weight loss.  The developer of the app will 
have access to coded data including: weight trends, app usage, problem foods identified, aversion 
techniques identified and food weights measured by the wireless scale and uploaded to the app. The 

app will utilize a code name chosen by the participant for guided prompts and all secure app messages 
to and from the mentor. No medical advice will be given.  Investigators will provide support and prompt 
participant to enter data as necessary. All phone conversations will be recorded.  
 
Statistics and plans for analysis: All outcome variables will be compared before and after the 
intervention using paired t-tests. Further analysis will compare the results of the W8Loss2Go program to 
the contemporary anthropomorphic changes in patients undergoing standard care in our EMPOWER 
program, using two sample t-tests.   
 
Risk: Less than minimal risk 
 
Study Timeline: 
IRB Submission by: 1/5/16 
Begin Pilot Recruitment (2 participants): 3/1/16 
Pilot: 3/1-5/1 
Begin Open Enrollment: 5/1 
Study Period: 5/1-1/1 
Analysis of Data: 1/1/17-3/1/17 
Manuscript Preparation: 3/1/17 
 
 

Participants Responsibilities: 
Participants will be loaned an iPhone 4/5S and accessories, with an AT&T service plan for the duration of 
the Pilot Study that includes: unlimited texting, 3 GB of data, unlimited voice calls to and from other cell 
telephones, 700 voice call minutes for calls to and from landlines and unlimited night and weekend calls 
to and from landlines.  
International calls or texts including Canada are NOT allowed and not covered.  
Participants will be responsible for the iPhone, any voice call minutes over 700 minutes, and any 
roaming charges. 
 Participants must agree to use the iPhone as their primary cell phone and use the W8Loss2Go app as 
my primary communications mode with the Pilot Study investigators and other members of the study 
group via the eRoom messaging and group chat system.  
Participants must agree to keep the iPhone with them during the day, other than at school where 
prohibited so that message alerts may be detected.  
Participant must agree to keep the iPhone charged and operational at all times and agree to charge the 
iPhone every evening.  
At the completion of the study participants must return the phone in good working condition.  
CHLA does not carry damage/replacement insurance on the iPhone. If the participants fail to return the 
iPhone, the AT&T service will be immediately terminated by AT&T, and the iPhone will be listed as 
“stolen property” in AT&T’s database and will be unusable.   
Those using their own iPhone 4S or 5 in the study will continue to be responsible for their own iPhone 
and iPhone service plans. 
 They must agree to have the W8Loss2Go app installed on their iPhone for the duration of the study.  
Participants must agree to the following iPhone care requirements: 
Keep the iPhone charged and operational to the best of my ability every day. Take care of the iPhone to 
protect against loss or damage; (Take care with charger cable, plug and earphones) 
Keep protective skin on iPhone screen at all times. 
Will not remove or replace protective case on iPhone at any time. We will replace at meetings if needed. 
Will not disable app alerts / notifications. 
Will not use iCloud to store anything during the study duration with this iPhone.  
Will not take iPhone to ATT or Apple Store for any reason.