An Addiction Model Based Mobile Health Weight Loss Intervention With Coaching in Adolescents With Overweight and Obesity: Multi-Site Randomized Controlled Trial
Phase: NA
Conditions: Pediatric Obesity, Mobile Technology, Addiction
Sponsor: Children's Hospital Los Angeles

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Protocol Version 8   
 
    
IRB Approval Date of below included protocol and statistical analysis Plan: 2/13/2023  
Publication date of primary results: March 18,2023 
Vidmar AP, Salvy SJ, Wee CP, Pretlow R, Fox DS, Yee JK, Garell C, Glasner S, Mittelman SD. An addiction-based 
digital weight loss intervention: A multi-centre randomized controlled trial. Pediatr Obes. 2023 
Mar;18(3):e12990. doi: 10.1111/ijpo.12990. Epub 2022 Dec 9. PMID: 36484235; PMCID: PMC9905275. 
NCT03500835  
An Addiction-Based Mobile Health Weight Loss Intervention With Coaching  
Find attached the study protocol and statistical analysis plan of the completed study. Primary outcome results have been 
published in pediatric obesity.   
    
Sincerely,    
    
Alaina P. Vidmar, MD (Corresponding Author) |     
Assistant Professor of Pediatrics    
Keck School of Medicine, University of Southern California    
Children's Hospital of Los Angeles     
The Center for Endocrinology, Diabetes and Metabolism     
4650 Sunset Blvd., MS #61 | Los Angeles, CA 90027    
Ph: 323-361-3385 | Fax: 323-361-1301 |  avidmar@chla.usc.edu    
    
  
  
 
 
     
   
   
   
   

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Protocol Version 8   
Background and Significance:  
  
One in five adolescents in the U.S. is obese3.  It has been theorized that overeating may have addictive 
qualities4, 5, and there is a growing body of literature which demonstrates that craving for drugs and drive for 
food share similar hypothalamic pathways as seen on functional MRI (fMRI) studies1, 2. A recent study by 
Tompkins et al. reported the prevalence of adolescents meeting the criteria for food addiction as 30.7%, well 
above the 15%–19% range observed in adults seeking obesity treatment6. Interestingly, few weight 
management interventions have tested therapeutic techniques founded in addiction medicine principles to 
date7.    
  
The general consensus is that clinical interventions for adolescent obesity require intensive 
management with multidisciplinary teams, frequent visits, and many contact hours 3. These programs often 
address nutritional, physical activity, and behavioral topics and only a handful of behaviors (e.g., selfmonitoring 
of weight, consistent physical activity, regular eating patterns). However, the high prevalence of pediatric, as 
well as adult, obesity precludes this as a practical strategy to combat obesity8. Advances in mobile health 
technologies (mHealth) offer an opportunity to monitor various behaviors, such as food consumption, and to 
deliver interventions in the adolescent’s natural environment9-12.Thus, mHealth platforms may be a cost saving 
alternative to an in-clinic intervention for pediatric weight management9, 13.   
  
Pretlow et al. reported an intervention which applied conventional addiction intervention methods to 
obesity in adolescents and was embodied as an iPhone® app7. To date, this addiction based mHealth program 
has been tested in two pilot studies. The first was performed in a self-selected cohort of 47 obese young 
people between 12-21 years of age and demonstrated that a food withdrawal approach was feasible to 
implement in a community based population without undue risk to participants and was useful in promoting 
weight loss7, 14. The results from this pilot study demonstrated a 7% decrease in the percent over the 50th 
percentile of BMI upon completion of the intervention7.   
  
  
The second pilot study was conducted in otherwise healthy adolescents referred to a tertiary care 
weight management clinic. A total of 50 adolescents were recruited; 18 youth self-selected to participate in the 
app intervention, the 32 youth that declined to participate functioned as contemporary controls who received 
intensive weight management intervention via a multi-disciplinary in-clinic intervention. Mean age of 
participants was 14.4 years (range, 12.3-17.9).  The female to male ratio, racial/ethnic distribution and zBMI at 
baseline were comparable between groups; app participants had a significant decrease in zBMI at 3 and 6 
months, compared to control. There was a statistically significant difference in zBMI between the app and 
control upon completion of the intervention (p=0.03). App participants had higher retention (100% vs. 37%) and 
lower total cost per patient ($760.00 vs. $1,428.00) than the control. An addiction medicine-based mHealth 
intervention, embodied as a smartphone app with telephone coaching, targeted for adolescents, reduced zBMI 
better than in-clinic controls and appears to be a cost-effective, timely and labor-saving method for adolescent 
weight management.   
  
  
Although these results are encouraging, they arise from relatively small, time limited studies, which 
lacked a ‘routine care’ group and incorporated potential biases in selecting the control population. In addition, 
the effect of coaching on weight loss in adolescents, independent of the app intervention itself, was unable to 
be elucidated. There is a growing body of literature to suggest that incentivized coaching alone may be an 
effective technique for weight loss in this population15, 16. Health coaching is a personalized approach that is 
being widely used to improve health behaviors in patients with obesity. In adolescents, health coaching is a 
promising strategy that promotes healthy behaviors, goal setting and increased self-efficacy17, 18.  Although 
data from randomized clinical trials in adolescents are limited a health coaching behavior modification program 
alone may be an effective, low-cost, personalized and flexible program that can be implemented through 
clinical settings.   
  

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Protocol Version 8   
  
The present study builds upon the momentum, resources, and research infrastructure of our pilot work 
to test the larger-scale and sustained impact of an addiction-based weight loss mHealth intervention with 
personalized coaching.  Specifically, the proposed multi-site randomized controlled trial (RCT) tests will test the 
efficacy of an interactive addiction model based mobile health (mHealth) weight-loss intervention with 
personalized phone-coaching (AppCoach) compared to 1) interactive addiction model based mHealth 
weightloss intervention alone (App) or 2) Multidisciplinary in-clinic weight management program (Clinic).   
  
  
The RCT will include youth regardless of their underlying co-morbidities because the targeted 
behaviors and weight management strategies are relevant and beneficial for all overweight and obese 
adolescents. Not only does this delivery modality remove many barriers (e.g., transportation, missed school 
days) that impact access and attrition in conventional, outpatient obesity interventions, but it strategically 
addresses underlying addictive eating behaviors to better support habit-formation in youth in their day-to-day 
environment. Assessment of the intervention’s effect on zBMI, %BMIp95, fasting metabolic parameters, 
addictive eating habits, executive function, and motivation for change will be obtained at enrollment, 3, 6, 12 
and 18 months (1 year post intervention follow up).  Another key aim of the study is to conduct a real-life 
economic analysis (costs, cost-savings and non-monetary benefits) of delivering the app with personalized 
phone- coaching compared to multidisciplinary weight-management. We will further explore whether primary 
and secondary outcomes differ by race and whether race moderates the relationship between initial 
intervention efficacy and prolonged weight maintenance.    
  
   
This study is both clinically and theoretically innovative as the notion of overeating as an addictive 
process in adolescents is still controversial. To our knowledge, this study is the first RCT to explore the efficacy 
of a weight-loss intervention premised on addiction principles delivered via mobile health. This study will 
contribute to the development of effective mobile health weight management interventions for use in 
adolescents with obesity. This extended intervention and follow-up (i.e., six months of intervention + one year 
of follow-up), will provide important information about the maintenance of this intervention. Second, it will aim 
to evaluate the use of mobile health interventions for adolescent obesity with coaching compared to mHealth 
intervention alone. Given the dearth of intervention options for obese children, the high likelihood that obese 
children will grow into obese adults, and our lack of understanding as to how best to personalize obesity 
interventions to optimize outcomes, this intervention may shift the approach of management of youth with 
obesity.   
  
  
  
Research Design Methods:   
Study Design:   
Multi-center, randomized, controlled, trial of an addiction based mobile health (mHealth) weight loss 
intervention plus personalized coaching (AppCoach) compared to receive 1) interactive addiction model based 
mHealth weight-loss intervention alone (App) and 2) Multidisciplinary in-clinic weight management program  
(Clinic).   
  
Recruitment and Eligibility:  
Study procedures will be approved by the Children’s Hospital Los Angeles (CHLA), the Los Angeles  
Biomedical Research Institute at Harbor-UCLA Medical Center, UCLA, and Cedars Sinai Institutional Review 
Boards.   
  
Recruitment Strategy:  
1. Clinical Referral: Potential participants will be recruited for the intervention arms from newly referred 
patients of 4 interdisciplinary weight management clinics (CHLA, Los Angeles Biomedical Research 
Institute at Harbor-UCLA (LA Biomed), UCLA, and Cedars Sinai). Patients will also be referred from 
AltaMed (at CHLA).  

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2. Targeted Mailing: Potential participants will be recruited via targeted or direct mailing. Direct mailing 
provides the opportunity to target specific family demographics and zip codes, and thus, to target large 
populations of specific age brackets, as well as specific ethnic, racial and socioeconomic strata. In the 
proposed study, we will send 20,000 letters to families with children ages 14-18 across 40  
neighborhoods in LA County. If we notice that some neighborhoods yield fewer calls, additional letters 
will be sent to ensure that our sample is evenly distributed across the randomly selected 
neighborhoods. Interested individuals will contact the CHLA study team if they wish to learn more about 
the study or participate.  
a. infogroup.com  
3. CHLA Emergency Department: ED staff will be provided with recruitment flyers to distribute to eligible, 
interested youth. In addition, the CRCs will be available to come to CHLA and approach eligible youth 
after receiving approval to meet the family from the treating provider. CRC will screen potential ED 
patients via KIDs and contact parents of the kids that meet our criteria.  
4. Community Recruitment: The flyers will also be posted on community boards across the 40 LA county 
neighborhoods. Interested individuals will contact the CHLA study team if they wish to learn more about 
the study or participate.  
a. See Flyer: “Calling all teenagers”  
  
  
Sampling strategy:  
  
LA County neighborhoods (n=272) will be stratified based on socioeconomic status, race and ethnicity. 
Based on this classification, 40 neighborhoods will be randomly selected.  Based on LA County data and 
recent work with young adolescents in LA, we anticipate the following racial and ethnic distribution: 67% 
Hispanic, 17% white, 7% Asian, 2% black and 7% mixed or of a different race.    
  
Patient Subjects:  
  
Inclusion criteria include:  
1. Age 14-18 years  
2. Able to read English  
3. Body mass index [BMI] ≥85th percentile for age and gender  
  
Exclusion criteria include:   
1. Concurrent participation in an alternative weight loss intervention  
2. Uncontrolled, self-reported Blood pressure > 99th percentile for age, gender, and height  
3. Uncontrolled, self-reported known psychiatric illness and/or developmental delay   
4. Participants 
Inability to read English  
  
Parent Criteria:  
1. Have an eligible child who meets the eligibility requirements listed above  
2. Minimum age of 18 years old  
3. Speaks English and/or Spanish    
  
Pre-Screening:  
  
  
Clinic Recruitment:  
Newly referred patients to the interdisciplinary clinics will be pre-screened for eligibility prior to their first clinic 
visit by a study team member. The patients who meet eligibility criteria will be contacted via phone by a study 
team member. During the call, we will briefly introduce the study aims, intervention, and different groups. We 
will request the youth and family to consider participation and will thoroughly discuss the study at the consent 

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Protocol Version 8   
(baseline) visit. The study team member will obtain the eligible participants’ email address and send them a 
recruitment flyer via email if interest is expressed.   
  
AltaMed referral/recruitment:   
Patients that meet age and/or BMI criteria, will be provided with study recruitment material and/or the patient 
will be referred to the study team by AltaMed providers/staff. The study team will acquire patients name, age, 
BMI (if available) and contact information.    
  
Initial Visit (all participants):  
1. Study team member will meet in person/virtually with eligible participants and provide details about the 
study procedures, obtain written/electronic permission from one parent/legal guardian and assent from 
minor participants or consent from participants 18 years of age and answer any questions the 
participants and their parent/legal guardian may have.  
a. Upon obtaining consent from one parent or guardian and assent from each youth to participate in the 
study, participants will be randomized to one of 3 intervention arms (AppCoach vs. App vs. Clinic). If 
participant is consented via mail, the randomization will occur during the second part of visit 1. The 
participant will have the option of curbside pickup or mailing of study supplies. If consenting via mail, the 
study team will mail supplies to participant after receiving signed consent back. If consenting 
electronically via REDCap or DocuSign, study team will mail study supplies day of consent if possible.    
 
2. All consenting participants will complete a battery of surveys (Refer to Measurements section).   a. 
Youth:  
  
  
i. Yale Food Addiction Scale19    
  
ii. The Center 
for Epidemiologic Studies Depression scale20  
iii. The Perceived Stress Scale21  
iv. Behavior Rating Inventory of Executive function22   
  
v. 
Binge Eating Disorder Screener21   
  
vi. Physical Activity 
Questionnaire    
  
vii. Satisfaction Survey  
viii. Food Craving Questionnaire  
ix. The Adolescent Self-Regulatory Inventory (ASRI)23 x. Short form health 
survey form (SF-12) xi. EQ5-D  
               
xii. Stages of Change Questionnaire in Weight Management (S-Weight)  
  
  
b. Parents:  
i. Demographic Screen  
ii. Health Encounters  
iii. Parent Satisfaction Survey  
  
Outcomes:  
 
Covariates:  
  
  
  
  
  
Demographic Information  x  
 
 
 
 
Youth’s Perceived Stress Score  x  x  
x  
x  
x  
Family Member’s BMI  x  
 
 
 
x  
  
0  
3  
6  
  
12   
18   
Study Visit Window of Completion  
  
/ 
+ -  2  
weeks  
+ / -    
2 
weeks  
/ 
+ -  4  
weeks  
+ / -  4  
weeks  

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Protocol Version 8   
Primary Outcomes:  
 
 
 
 
BMI Status Change-                           
%BMIp95  
Height, Weight, zBMI,  x  
x  
x  
x  
x  
Secondary Outcomes:  
  
  
  
  
  
Adherence-  
x  
x  
x  
x  
x  
Satisfaction-                                       
Satisfaction Survey  
                                 
x  
x  
x  
x  
x  
Fasting Lab Tests-    
x  
 
x  
 
x  
Cost Analysis-                                    
Encounters*   
             Health Care  
x  x  
x  
x  
x  
Mediators:   
  
 
 
 
  
Addictive eating qualities-                  
YFAS and FCQ  
                                      x  x  
x  
x  
x  
Self-Regulation-                                 
ASRI  
                                      x  x  
x  
x  
x  
Executive Function-                            
BRIEF 2  
                                      x  x  
x  
x  
x  
  
*An official Health Care Encounters questionnaire will be completed by the parents at in-person/WebEx study 
visits at 0, 3 ,6,12, and 18 months post consent. Additionally, all participants will receive a call monthly from a 
study team member during the study period. In these calls weight outcomes, barriers and any interim health 
encounters (physician visits, diagnosis, medication prescribed etc.) occurred in the previous 4 weeks will be 
assessed.    
  
3. All consenting participants:   
a. AppCoach and AppAlone arms will receive:  
i. 
Loaned iPhone (app is iOS compatible only) if the participant does not already have 
one   
ii. 
Wireless Bluetooth body weight scale   
iii. Digital food scale  
iv. Measuring tape (if participating virtually)  
b. In Clinic arm will receive:  
i. Digital body weight scale  
ii. Measuring tape (if participating virtually)   
c. Participants in the AppCoach and App arms who require an iPhone will be loaned an iPhone 
and accessories (including protective case), with an AT&T service plan for the 6-month 
intervention of the study that includes: unlimited texting, unlimited plan, 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. iPhones will be returned at the completion of the 
intervention (visit 3: 6-month follow-up visit/mail equipment back to study team).   
d. One parent will complete the above-mentioned questions and have their height, weight and 
BMI measured/self-reported at consent and at 18-month follow up (end of study).   
3. AppCoach and AppOnly Participants:  

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a. Each participant will be registered with their email address via a computer and then login 
with the app.    
b. Participants will weigh-in on a scale in a private area and enter weight data into their 
iPhones. Participants will weigh themselves and their food daily.  This information will be 
automatically synced (entered) into the app. However, if the wireless scales are not used, 
they will need to enter the information manually into the app.   
c. A study team member will go through each section of the App and have participants enter 
data.  
d. Follow-up: participants will schedule in-person/WebEx study visits at 3, 6, 12 and 18 
months. Participants will also have the option of conducting visits virtually via WebEx and/or 
receiving survey links via email directly from REDCap.  
e. AppCoach participants will also schedule weekly 15-minute phone meetings with a coach in 
addition to follow up study visits in-person/WebEx visits at 3, 6, 12 and 18 months.   
4. In Clinic Participants:   
a. Each participant will attend a multi-disciplinary in-clinic or WebEx intervention consisting of 6 
sessions (120 minutes +/- 30 minutes); one session per month for 6 months.   
b. They will meet with several members of the provider team throughout the intervention:  
physical therapist, psychiatrist, Registered Dietitian, health educator, physician and research 
team.   
c. Participants will be weighed or provide a self-reported weight at every session and follow up  
visits   
d. Participants will have the option of weighing themselves daily.   
e. Follow-up: participants will attend in person/WebEx follow-up visits at months: 3, 6, 12, and  
18  
f. Participants will be provided a KNF newsletter for sessions 1-6. The newsletters summarize 
what was discussed during the session they attended. They will also be provided with a 
height and weight measurement tool. The newsletter and tool will be emailed or texted.   
5. Research Blood Draws (all arms):   
a. Fasting lab results at enrollment are needed to determine baseline values. Participants that 
were referred to a weight management clinic at any of the participating sites may have had 
these labs drawn as part of their routine care. These results will be abstracted from the 
medical record if they are within 8 weeks of consent date. However, a research blood draw 
will be done at enrollment if these labs were not done as part of the participant’s routine 
care. If the consent visit takes place virtually/by mail, the participant will be expected to 
travel to CHLA for a baseline research blood draw.   
b. All arms will have a follow up research blood draw at months 6 and 18.   
c. Each research blood draw will collect approximately 5 mL (1 teaspoon) of blood via 
venipuncture that will be used for the following testing: HbA1c, Total Chol, LDL, HDL, TG, 
AST/ALT, Glucose and insulin.   
6. All participants   
  
  
*Visit 1: if consenting via mail, these procedures will be completed at the 2nd session as visit 1 will be split in 2   
** Each participant will have the opportunity to earn up to $200 in gift cards for participation in this study: up to  
$50 for participation in the intervention at 3 and 6 months and $50 for going to the last 2 study visits (at 12 and  
18 months). The amount of payment will be based upon how much of the intervention the participant 
completes.    
***Visit 2 and 3 must occur within a 4-week period (+/- 2 weeks from the 3- or 6-month date) and Visits 4 and 5 
must occur within an 8-week period (+/- 4 weeks from the 12- or 18-month date).    
  
  
Study Visit Schedule for Group 3 (In-Clinic) (total visits = 9)  

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Protocol Version 8   
 
  
*Visit 1: if consenting via mail, these procedures will be completed at the 2nd session as visit 1 will be split in 2   
  
The youth participants in this group will also earn up to $50 at 3 months (visits 4) and 6 months (visit 7) for 
participation in the 6-month intervention and $50 for completion of study visits 8 and 9.   
  
The table below depicts the assessment time points and key measures.  
Month  
0  3  6  
12   
18   
Covariates  
  
  
  
  
  
Co-Morbidities, race/ethnicity, household composition, socioeconomic status, and 
previous weight loss programs completed  
x    
  
  
  
Primary Outcomes (Aim 1)   
  
  
  
  
  
Height, Weight, zBMI, %BMIp95  x  
x  
x  
x  
x  
Secondary Outcomes / Mediators (Aims 2, 3)  
  
  
  
  
  
Youth Surveyed:                          Yale Food Addiction Scale-Children  
x  
x  
x  
x  
x  
CES-D  x  
x  
x  
x  
x  
Perceived Stress Score  x  x  
x  
 x  
x  
BRIEF 2  x    
  
  
  
ASRI  x  x  
x  
x  
x  
Food Craving Questionnaire  x  x  
x  
x  
x  
Binge-Eating Disorder Screener  x    
x  
x  
x  
Satisfactory Survey  
    
x  
  
x  
Physical Activity Questionnaire  x  x  
x  
x  
x  
SF-12  x  x  
x  
x  
x  
EQ5D  x  x  
x  
x  
x  
S-Weight  x    
x  
  
  
Parent Surveyed:                                                                                                          
  
  
  
  
Demographic (Including Fast Food Consumption)  x    
  
  
x  
Height, Weight BMI  x  x  
x  
x  
x  
Health Encounters  x  x  
x  
x  
x  
Satisfactory Survey  
    
x  
  
x  
Fasting Lab Tests: HbA1c, Total Chol, LDL, HDL, TG, AST/ALT, Glucose, Insulin  
x    
x  
  
x  
  
Post Study Follow-up Options:   
1. After completion of the 6-month interventions participants will be offered the following choices for continued 
care:  
a. Participants in groups 1 and 2 will have access to use the mobile app without coaching upon 
completion of the 6-month intervention. However, a participant owned iPhone is required in order to 
use the mobile app. Group 3 will have access to use the mobile app without coaching upon 

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completion of the study (post 18 month). Participants will have to own an iPhone in order to use the 
mobile app as it is an IOS App only.   
  
   
2. All participants will receive a call from a study team member monthly for the 18-month study period.  
a. They will discuss weight trends since the intervention completion and any interim health encounters 
(ED visits, hospitalizations, PMD visits, changes to medical history).  
b. They will also discuss if any interim weight management strategies have been utilized or started.  
  
3. All Participants will have an in person/virtual follow up 12 months and 18 months post consent (baseline) 
where a repeat weigh in and survey completion will occur. All participants will also have a fasting research 
blood draw at 6 and 18 months.  
  
  
  
Enrollment and Retention:  
  
Up to 404 adolescents (plus 1 parent/youth enrolled) will be recruited for the intervention arms and 
randomized 1:1:1 via stratified block randomization into one of the following groups: AppCoach, App or Clinic.  
Demographic information will be collected from all participants. During the intervention period the participants 
will not attend an inter-disciplinary in-clinic weight management intervention or any other medically supervised 
weight loss programs. If the participants have underlying comorbidities, they will continue to follow with routine 
subspecialty providers for standard of care of each underlying condition. Each participant’s primary care 
provider, regardless of the method in which they were recruited (including those recruited from the greater LA 
county) upon request from participant, will receive a letter from the PI explaining that the individual will be 
participating in the research intervention during the allotted study period. Parental involvement is not required 
for those participants randomized to the AppCoach or App group; these participants will complete the 
intervention independently with the assistance of the coach (if applicable). Parental involvement is required for 
those participants randomized into the In-Clinic group. Upon completion of the intervention, if the participant 
was initially referred to a weight management clinic by their primary care provider, they will be offered 
continued enrollment in the inter-disciplinary weight management clinic for which they were initially referred. In 
order to further remove barriers to participation, all families who do not have a car will be offered free 
ridesharing transportation (UBER or Lyft) to- and from CHLA. Additionally, parking validation will be offered for 
families to park onsite at CHLA for research and/or intervention visits. To increase retention, participants are 
contacted once per month to maintain engagement. Research staff will provide families with dates of their 
scheduled assessments/visits. Participants are also given reminder phone calls the day before their 
assessment/visit.  
  
Trial sites:  
A participating trial site must fulfill the following eligibility criteria:  
1) Have an independent weight management clinic that cares for adolescents.   
2) The principal investigator and all the clinical research coordinators/staff at the site have been trained on, and 
understand, the study protocol.  
3) The site is within mobile phone range on the other hand, a trial site will be ineligible if it satisfies one      or 
more of the following conditions:  
1) The principal investigator withdraws consent for participating in the study.  
2) The steering committee of the present trial judges the site to be inappropriate to recruit participants.  
  
Initial trial sites include: CHLA, Los Angeles Biomedical Research Institute at Harbor-UCLA (LA Biomed), 
UCLA, and Cedars Sinai.  
  
Site Training:  

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Each on-site CRC will receive 8 hours of training prior to recruitment start date.   
  
Study Design:   
404 reflect the 190 youth and 190 parent/guardians plus the 12 youth and 12 parent/guardian subjects that will 
be enrolled for the pilot study at CHLA.  
  
We are aiming to recruit a total of 292 youth total with 1 parent/legal guardian per youth (total of 584 including 
the parent/guardian in the subject accrual number + 12 pilot youth + 12 pilot parent/guardian).   
  
We plan to enroll 584 participants (youth & parent/guardian) into each intervention arm as follows:  
  
CHLA/AltaMed = 404 (Pilot: 12 youth + 12 parent/guardians; Open enrollment: 190 youth & 190 
parent/guardians)  
UCLA = 60 (30 youth & 30 parent/guardians)  
Harbor UCLA = 60 (30 youth & 30 parent/guardians)  
Cedars Sinai = 60 (30 youth & 30 parent/guardians)  
  
Pilot Group: We plan to initially recruit 12 patients from the CHLA EMPOWER clinic. The patients will be 
randomized to the three intervention arms and will complete a 2-month trial to assess intervention fidelity of the 
curriculum and identify any potential difficulties. The pilot subjects are reflected in the information above. . 

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Assessments:  
Anthropometric Data  
  
Height and weight will be assessed at in-person visits by study team member or or self-reported if visit 
is conducted virtually via WebEx. Height will be measured using a Quick Medical stadiometer, accurate to 0.1 
cm (Quick Medical, Issaquah, WA). Weight will be measured on a self-calibrating Mobile Stand Digital Scale, 
  
CHLA/AltaMed 
n=404 
AppCoach 
n=135 
App 
n=135 
Clinic 
n=135 
Harbor UCLA 
n=60 
AppCoach 
n=20 
App 
n=20 
Clinic 
n=20 
UCLA 
n=60 
AppCoach 
n=20 
App 
n=20 
Clinic 
n=20 
Cedar - Sinai 
n=60 
AppCoach 
n=20 
App 
n=20 
Clinic 
n=20 

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Protocol Version 8   
accurate to 0.1 kg. Participants will wear minimal clothing during the height and weight measurements. BMI will 
be calculated as kilograms per square meter and BMI Z-score (zBMI) and percent over the 95th percentile 
(%BMIp95) will be determined utilizing the CDC growth charts.   
  
Physical Activity  
 To evaluate the effect of the intervention arms on amount of physical activity performed by the youth, each 
youth will complete the physical activity questionnaire and recall their activity level over the last 7 days at each 
study visit.   
  
Measurements (~ 1.5 hour to complete)  
1. 
Yale Food Addiction Scale (YFAS-c, 25 questions, ~7 minutes): The YFAS-c is a validated measure 
of addictive-like eating behavior based on the Diagnostic and Statistical Manual of Mental Disorder V 
diagnostic criteria for substance dependence19, 25, 26. Intervention participants will complete the YFAS-c at 
consent and at 3, 6, 12 and 18 months.  
2. 
The Center for Epidemiologic Studies Depression scale (10 questions, ~5 minutes): The CES-D 
is a short self-report measure used to measure depressive symptoms in the general population20. The scale 
demonstrates strong internal consistency (Cronbach’s α > 0.85), moderate test-retest reliability (>0.50), and 
moderate validity (r > 0.50)20. This will be completed at all in person / WebEx study visits 0,3,6,12, and 18.   
3. 
The Perceived Stress Scale (14 questions, 10 minutes): The PSS measures subjective perceptions 
of distress in one’s own life situations. Based on Lazarus’ transactional model of stress and coping, the PSS 
assesses how well a person feels they can cope with stressors, rather than measuring the nature of the 
stressors themselves. The measure has demonstrated strong reliability (r > 0.80) and validity in social and 
health science studies21. This will be completed at all in person/ WebEx study visits 0,3,6,12, and 18.   
4. 
Health Encounters (6 questions, 5 minutes): This brief questionnaire will assess how often the 
participant has utilize health services in the preceding time period.  An official Health Care Encounters 
questionnaire will be completed by the parents at in-person/WebEx study visits at 0,3 ,6,12, and 18 months 
post consent. Additionally, all participants will receive a call from a study team member monthly during the 
study period. In these calls the study team member will assess weight outcomes, barriers and ask if any 
interim health encounters (physician visits, diagnosis, medication prescribed etc.) have occurred in the 
previous 4 weeks). 5. Intervention Satisfaction Survey (12 questions, ~6 minutes): Both the study 
participant and a family member will complete an intervention satisfaction survey to be completed at the 6 and 
18 month follow up visits to assess the level of satisfaction with the intervention period and the satisfaction with 
the coaching.   
a. Participant Satisfaction  
b. Coach Satisfaction  
c. Parent Satisfaction  
6. Demographic Questionnaire (15 questions, 6 minutes):   
a. Age of consenting parent/guardian  
b. Ethnicity  
c. Highest education obtained of consenting parent/guardian  
d. Household Composition  
e. Parent employment status  
f. Fast Food Consumptions Question: How often did you eat outside the house in the last 7 days  
1. Guardians will be asked to report how often in the past 7 days the participant ate a meal or a 
snack from a fast-food restaurant.  Response options range from  “none” to “5 or more times. 
This procedure is similar to measures used in other studies of fast-food consumption. Guardians 
will also be asked to report the location (e.g., McDonald close to school) and the social context 
in which eating occur (e.g., with school friends).  
7. The  Adolescent Self-Regulatory Inventory (ASRI, 36 questions, ~15 minutes)23: This is a 36 item 
measure that evaluates the degree to which adolescents are able to activate, monitor, maintain, inhibit, and 

13  
  
Protocol Version 8   
adapt their emotions, thoughts, attention, and behavior. This will be completed at all in person/ WebEx study 
visits 0,3,6,12, and 18.   
8.Behavior Rating Inventory of Executive function 2 (55 questions, 15 minutes)22: The Behavior Rating 
Inventory of Executive Function (BRIEF2) provides theoretically and empirically derived clinical scales that 
measure aspects of executive function. The clinical scales form broad indices of behavior and cognition and an 
overall score, the global executive composite (GEC)22. This will be completed at baseline only.   
9. 
Food Cravings Questionnaire (FCQ, 15 questions, ~5 minutes)24: Scores on the FCQ-T have been 
found to be positively associated with eating pathology, body mass index (BMI), low dieting success and 
increases in state food craving during cognitive tasks involving appealing food stimuli. This will be completed at 
all in person/ WebEx study visits 0,3,6,12, and 18.   
10. 
Binge Eating Disorder Screener (BEDS-7, 7 questions, 4 minutes): This questionnaire is utilized to 
screen for binge eating disorders. This will be completed at in person/ WebEx study visits 0,6,12, and 18.  
11. 
Physical Activity Score (PAQ, 12 questions, 4 minutes): This instrument was developed to assess 
general levels of physical activity for adolescents 14-19 years of age.27 This will be completed at all in person/ 
WebEx study visits 0,3,6,12, and 18.   
12. 
SF-12 Health Survey (12 questions, 3 minutes): The SF-12 is a practical, reliable and valid measure 
of physical and mental health. It is particularly useful in large population health surveys or for applications that 
combine a generic and disease-specific health survey. This will be completed at all in person/ WebEx study 
visits 0,3,6,12, and 18.   
13. 
EQ5D (15 questions, 4 minutes): EQ-5D is a standardized instrument for measuring generic health 
status. It has been widely used in population health surveys, clinical studies, and economic evaluation and in 
routine outcome measurement in the delivery of operational healthcare. This will be completed at all in 
person/WebEx study visits 0,3,6,12, and 18.    
14. 
S-Weight (5 item questionnaire, 3 minutes): S-Weight is a tool used to determine the individual's stage of 
change. This allows the research team to assess and monitor motivation and readiness for change to determine if baseline levels 
promote success in the intervention.  
  
Adherence and Retention  
  
Data relating to participant interaction with the app and the coach and attendance with scheduled 
research visits will be tracked remotely and stored on HIPAA-compliant central servers. Data will be reported 
on three key components specific to the underlying addiction model implemented in the intervention: (1) 
‘‘problem foods’’ withdrawal; (2) snacking elimination; and (3) food amount reductions at meals12. We will also 
use strategies (implemented with participants in the intervention arms) that we have found effective for 
retention: (1) providing incentive for participation and adherence; (2) ensuring frequent contacts with all 
participants to maintain engagement and foster open communication; (3) sending email and text reminders 
about face-to-face/WebEx visits; (4) seeking contact information of relatives or friends to be able to reach 
participants; and (5) Study participants will be invited to participate in two optional audio recorded focus groups 
to: 1) collect information on their experience with the study and 2) their understanding of displacement theory 
and their input on the development of a new app based intervention that targets the displacement theory. The 
focus group sessions will last 60 minutes each. As we are recording the sessions, if a patient’s real name is 
accidentally used, it will be erased from the transcript and if possible, from the audio-recording. Participants will 
have the option of participating in both or just one of the focus groups in no particular order so long as they 
have completed their 6-month follow up visit or none. This will help us identify adherence outcomes.   
  
Intervention Groups:  
  
App Intervention Groups (AppCoach and App groups)  
  
The specific details of the App intervention have been described by Pretlow et al7. Briefly, the 
intervention will be implemented through an iPhone® app, which will be securely integrated with a 
networkserver for real-time data access and storage7. Problem foods will be defined as specific foods for which 
participants felt they have cravings, cannot resist when immediately available, and cannot stop eating when 

14  
  
Protocol Version 8   
started. Participants will sequentially withdrawal from two self-selected problem foods at a time, with the goals 
of total abstinence from the food for a minimum of 10 days in a row, and craving resolution2.   
  
During the second phase, which will overlap with the first, participants will eliminate snacking by 
choosing time periods to avoid snacking (i.e. morning, afternoon, or evening). Once the participant has 
abstained from snacking during their chosen time interval for 10 days, the participant will then choose 
additional time intervals to abstain from snacking, with the overall goal of abstinence from snacking between 
meals. In the third stage, excessive food amounts at meals will be targeted. Participants will weigh all food 
items served at meals, and an algorithm in the app will gradually reduce each participant’s food amounts to 
result in 1 pound weight loss per week. Participants will take photos of meals via the app, post weighing, to 
allow for external confirmation of amount reduction. In addition, participants will have access to the app home 
page, which includes various addiction model strategies, including: motivation, distraction ideas, displacement 
methods and coping skills techniques7.   
  
Participants in the AppCoach and App group will be asked to weigh themselves and food daily. All 
participations (AppCoach, App and Clinic) will receive monthly phone calls from the research team to speak 
with either the subject or the parent to review any barriers to adherence or technological problems that may 
have occurred with any of the study equipment. All phone conversations will be recorded.   
  
Coaching (AppCoach group)  
  
Interactions between coach and participants are of three types: face-to-face/WebEx visits, phone calls 
and text messages. Each participant will interact with the coach for 6 months via text messages, 5 days per 
week, weekly phone calls (15-minute duration) and four one-hour face-to-face visits (at 3, 6, 12 and 18 months 
post baseline visit). Participants will keep track of their progress through the mobile app, throughout the 
intervention; this log will be reviewed with the coach weekly. The face-to-face visits (1 baseline consent visit 
and 4 follow up visits) will be qualitative interviews (of approximately 60 minutes duration), which will occur at 
Visit 2 (month 3), 3 (month 6), 4 (month 12) and 5 (month 18). The semi-structured interviews will include 
questions designed to elicit both positive and negative impacts on weight management and identify barriers 
such as emotional eating, displacement behaviors, poor coping skills to life stressors and social challenges. 
The interviews will be broadly structured around key domains of life before the intervention, life during the 
intervention, and anticipated future life. Upon completion of the intervention the participants will be interviewed 
on their own sense of what was important about the intervention in terms of what did/didn’t impact them and 
their thoughts on how the intervention could be improved.   
  
Most of the participant-coach interactions take place through phone calls. Each coach will have a cell 
phone used solely for this study, so that participants may directly contact their coach as needed regarding any 
questions or concerns that the participant may have. Phone calls and text messages will be utilized for 
appointment reminders, scheduling weekly phone meetings, providing emotional support, following up on items 
discussed in a prior visit or phone call30. All interactions are documented in a database created for the study, 
including date, time, type, and duration of contact, topics discussed, and any relevant notes. The coach will 
utilize a motivational interviewing paradigm to interact with the participants, and an electronic system within the 
app database to document each encounter. All phone conversations, for those in the AppCoach group, will be 
audio recorded. In addition, AV will attend 1 coaching session per month for intervention fidelity assessment in 
real time with the coaches.  
  
Addiction Model Based Coaching Curriculum:  
  
The curriculum is founded on three principles of addiction medicine:1) Divide-and-conquer approach; 2)  
Staged withdrawal / abstinence; and 3) Behavioral addiction (BFRB intervention methods (See Manual of 
Procedure entitled: Addiction Model Intervention for Obesity in Young People for additional detail). Specifically, 
the intervention targets three features of addictive behavior: 1) Staged withdrawal from participant identified 
problem foods; 2) Staged withdrawal from daytime snacking between meals; and 3) Withdrawal from excessive 
amounts of food consumed at meals. The curriculum also addresses self-monitoring of weight and targeted 

15  
  
Protocol Version 8   
behaviors to support habit-formation of eating behaviors. Regular self- weighing and completion of the records 
are associated with program adherence and successful weight management.   
  
  
  
The divide-and-conquer approach breaks down the addictive behavior and the withdrawal process into 
components, which are attacked one at a time in discrete, small increments. It is productive to divide 
intervention into problem foods, snacking, and excessive amounts at meals, and each involves treating both 
the sensory and motor addiction components.  
1) Withdrawal from problem foods: Problem foods are specific foods for which the child  or teen has  
 
cravings, seeks out or purchases, cannot resist when immediately available, and cannot stop eating  
 
when started. The child or teen identifies and lists all his/her problem foods and then abstains from  
 
each food, one-at-a-time, for nominally 10 days each, and until cravings and difficulty resisting the food  
 
have resolved (designated as “in-control” for that food). Then the child/teen progresses to the next  
 
problem food on his/her list. Two problem foods may be withdrawn from concurrently, but it is  
 
recommended that no more than two problem foods be withdrawn from at a time.   
2) Withdrawal from snacking/grazing: This is accomplished by abstinence from snacking  during distinct  
 
time intervals, such as morning, afternoon, evening or nighttime, nominally for 10 days each time period  
 
and until difficulty resisting snacking during that time period has resolved (designated as in-control  
 
for that time period). Then the child/teen progresses to the next time period, with the goal of zero  
 
snacking during the entire day. Snacking may be withdrawn from in more than one time period  
 
concurrently.  
3) Withdrawal from excessive food amounts: This may be accomplished in two ways:  
a) 
Cutting in half method. Cut everything in half eaten at meals, put half back,   
  
 
and eat only half. Sharing with a friend or boxing up half when eating out is useful.   
b) 
Measuring/weighing method. Measure or weigh typical amounts of all foods   
  
 
frequently eaten at meals and reduce amounts in incremental, staged   
  
  
 
percentages from starting amounts. Weighing foods is much easier to   
  
  
 
implement that the cutting in half method, as it turns the quantity of food served into a 
number. Thus,   
there is no “decision” and minimal stress.  
4) Behavioral addiction methods are used in parallel for each withdrawal process.  
  
Coach Training Procedures:  
  
The coaches delivering the curriculum will receive 60 hours of training over a 4-week period from Dr. 
Vidmar. The training covers: 1) the importance, rational and education about the theory of food addiction and 
the proposed intervention, 2) the concept of behavior change, patient centered approach and 
motivationalinterviewing techniques, and 3) practical advice specific to each stage of the intervention and ways 
to assist the youth with common barriers and triggers. The coaches will also tailor the delivery of information 
and the setting of goals to the participant's readiness for change. Coaching curriculum will cover active 
listening, nonjudgmental communications, motivational interviewing techniques, and creating self-management 
goals. In addition, the two coaches will be required to demonstrate mastery of coaching skills through 
simulated roleplays and observations of coaching sessions. Coaches will have ongoing support from the study 
PI (AV) via bimonthly meetings at which they may present participant cases and request guidance with specific 
issues and may consult with the study investigators as needed.  
  
Once the coaches complete the training and demonstrate mastery of the skills, they will be assigned 
participants in the AppCoach group.  The AppCoach group will be the only arm with a personalized coach. 
Each coach makes initial contact (via HIPAA secure video conferencing) with the participant at the time of 
enrollment to describe his or her role and to discuss participant identified goals.   
  
Coaches will have undergraduate training and be highly knowledgeable about motivational interviewing 
clinical practice guidelines regarding strategies for obesity management in youth. Coaches will be taught to 
table unfamiliar clinical and counseling questions, which may arise during coaching. They will then discuss 
these questions with Alaina Vidmar (AV) at bi-monthly team meetings, who will provide direction about 
management on future calls. Coaches will record all calls, and AV and SS will review a subset of these 

16  
  
Protocol Version 8   
recordings. Coaches will receive monthly feedback regarding implementation of directive and nondirective 
coaching modes.  
Clinic: Multi-Disciplinary In-Clinic Monthly Intervention (In-Clinic Group)  
  
The team consists of a coordinator/health educator, physicians (MD), registered dietitian (RD), physical 
therapist (PT) and psychologist, who will assess participants in a clinic setting/virtually, with monthly visits with 
one or more providers (averaging 100 minutes at the initial visit and 80 minutes per follow up visit, ~8 contact 
hours per participant per 6-month intervention period). Core principals of the clinic include motivational 
interviewing (MI) and family-centered care.  Patients and their parent/guardian are expected to attend monthly 
clinic visits for at least six visits (6 months). The study team member will obtain height and weight at the 
beginning of each visit.   
  
The coordinator/health educator will evaluate the patient and families overall emotional health and 
address anxiety, psychosocial stressors, and emotional eating. Healthy eating goals focus on hunger 
management, portion control, decreasing sugar-based beverage intake, increasing fruit and vegetable intake, 
and modifying eating behaviors.  Changes in behavior for the entire family are strongly encouraged.    The 
multi-disciplinary team utilizes treatment strategies that include MI, nutritional education, and behavioral 
therapies targeted at improving daily routines, emotional health, sleep quality and quantity, diet, and physical 
activity. Each team member documents the patient’s goals identified at each visit and distributes a summary 
check-out document to the team and the family. Goals for healthy eating, increased physical activity, better 
sleep habits, emotional well-being, and family support are then followed up at subsequent monthly visits.   
  
The Clinic Intervention will utilize the Kids N Fitness Curriculum and will address the following topics over the 6-
month intervention:  
Session 1: Nutrition and Food Groups   
Session 2: Portion Power  
Session 3: Real Foods, Fat and Fiber  
Session 4: Sugar Savvy  
Sessions 5: Healthy Shopping, Healthy Eating  
Sessions 6: Special Occasions and Moving Forward  
  
Those youth randomized to the in-clinic control arm will complete the intervention at CHLA or virtually via 
WebEx. The participant and their parent/guardian will meet with each team member for 20-30 minutes to 
discuss the topic of the session. The youth will participate in some mild physical activity exercises, such as 
stretching. Treatment fidelity strategies will be utilized for all three intervention arms to ensure the accurate and 
precise delivery of each arm as intended. (See Treatment Fidelity Below).   
  
Example Follow up Phone Calls Curriculum Outline (AppCoach):   
Call  
  
1  
Introduction:  
     --Coach introduction  
     --Curriculum introduction  
     --Problem Food Identification   
     --Goal setting  
2  
Personal Motivation:  
Identify personal motivation and goals of each participant.  
Have participant identify in and out of home barriers to weight management success.  
Problem Food Withdrawal  
Instruct to complete personal story   
3  
Problem Food Withdrawal  
-Assess barriers to compliance  

17  
  
Protocol Version 8   
4  
Problem Food Withdrawal Progress  
5  
Introduce Snacking Elimination. Identify period of time to start withdrawal Problem Food and 
Snacking Withdrawal  
6  
Problem Food and Snacking Withdrawal  
7  
Problem Food and Snacking Withdrawal  
8  
Problem Food and Snacking Withdrawal  
9  
Continue PF and Snacking Withdrawal start food amount reduction Evaluate 
current barriers to weight management success.   
Have participant identify one goal to achieve over the next 4 weeks  
 
Introduce food weigh  
AppCoach and App: Distribute App setup instructional video   
10  
Progress report on above. Review frequency of eating out. Review missed weighed meals   
11  
Review progress, compensation and points earned. Identify successes and barriers. Make 
goals for second half of intervention  
12  
Review Face to Face / WebEx Visit 2  
Goal of withdrawing from all 10 PF by week 12  
13  
Review maintenance PF avoidance. Encourage to consider assigning additional PF as 
tolerated  
14  
Goal of eliminating snacking by week 14  
15  
Review maintenance of PF and snacking avoidance   
16  
Review daily foods weigh in. Review how many meals have been weighed. Review how to 
weigh accurately. Review food amounts and discuss if within target. Review food pictures to 
ensure honest measurement  
17  
Review weight loss and create goals for weight loss. Review addiction model and review for 
signs of withdrawal/tolerance since removal of PF and snacking   
18  
Identify barriers to food amount withdrawal. Create personal goals to overcome barriers.   
19  
Assess barriers to long term adherence. Identify in home and out of home barriers to weight 
loss success/maintenance  
20  
Review maintenance of PF and snacking avoidance  
21  
Review food amount withdrawals and strategies to consume smaller portions  
22  
Review weight loss and create goals for weight loss. Review addiction model and review for 
signs of withdrawal/tolerance since removal of PF and snacking  
23  
Review weight maintenance strategies 
Review print out of weighed foods  
24  
Review Face to Face / WebEx Visit 3  
  
Intervention Delivery:  
  
The proposed model of delivery makes it possible to: 1) Intervene with the adolescent and provide 
autonomy, 2) deliver the material over an extended period of time in a more convenient platform for the youth 
and families, 3) reduce many access barriers (transportation, missed days of school and work) common to 
conventional outpatient obesity interventions, and 4) help youth learn skills to help them overcome their 
addictive eating traits.   
  
Intervention Fidelity:  

18  
  
Protocol Version 8   
AppCoach and App Groups  
  
Intervention fidelity encompasses integrity (interventions are implemented according to established 
procedures) and differentiation (interventions are distinct from one another). Our formative work suggests that 
the following strategies and safeguards are effective in preserving integrity and differentiation: (1)  
Comprehensive assessment of the curriculum. (2) As described above coaches will receive extensive training 
to master the curriculum’s psychosocial and educational curriculum (supported by scripted manuals) and they 
receive weekly supervision. The training, scripted manuals and supervision prevent drifting (i.e., avoid covering 
topics/areas not included in the curriculum). (3) Coaches will receive an initial training period and refresher 
courses throughout the study period. Implementation quality is further supported by scripted manuals and by 
weekly supervision to review progress, dosage and timing of delivery, and to provide the opportunity to resolve 
problems or issues encountered. (4) Coaching is delivered via phone with audio recording of each sessions. 
Coaches will be provided with session outlines as a material guide and following the sessions, Drs. Salvy and 
Vidmar will review the sessions utilizing a session checklist to ensure treatment fidelity. The recorded sessions 
will be monitored by Dr. Salvy periodically over the course of the study to ensure compliance with coaching 
instructions and prevent any drifting.  
  
In-Clinic Arm:  
  
A similar treatment fidelity schema will be implemented for the in-clinic intervention. The curriculum will 
be adapted to target youth ages 14-18. The providers implementing the intervention will complete 12 hours of 
training that will include mock implementation. The providers will implement the intervention and Dr. Salvy will 
evaluate the implementation and ensure session objective and checklists were correctly incorporated and 
prevent any drifting over time.  
  
Pilot Sessions:  
  
  
Twelve participants (and one of their parent/guardian) will be recruited from CHLA to complete a pilot 
intervention starting 2 months before the initial open recruitment commences. The youth participants will be 
randomized to one of the three arms and complete that intervention accordingly. The team members will 
continue to be monitored as they implement the intervention and barriers to execution will be evaluated. Those 
12 participates will complete the full study period. If not protocol amendments are made they will be included in 
the final analysis, if protocol amendments are made they will be excluded.   
  
Intervention Compensation:   
  
  
Traditional payment: Payments will be provided at the end of study visits at months 3, 6, 12, and 18 as 
shown in the table below. Monthly payment: The participant may elect to receive compensation at monthly 
intervals for the first 6 months if desired. If this method is selected, the participant  will provide the study team 
with their email address and a gift card will be emailed to them monthly based upon how much of the 
intervention they participate in or they can opt for the study team to email them images of the gift cards.  
Each youth participant, regardless of which group they are assigned to, will receive compensation in the 
form of gift cards. Each youth participant has the opportunity to earn up to a total of $200 for participation in 
this study. The amount of payment will be based upon how much intervention adherence occurs. The amount 
will be rounded to the nearest ten-dollar increment, by rounding up.    
  
Parents/guardians will not be paid for their participation in this study.  
  
For Group 1 (AppCoach) and 2 (App):   
The app will automatically accrue points as the participant interacts with the app components. They will receive 
a pre-determined amount of points each time they open the app, each time they weigh in, each time they log a 
problem food, etc. The participants will be able to enter the motivation section of the app as desired to evaluate 

19  
  
Protocol Version 8   
how many points they have accrued. In addition, lack of participation with the app results in loss of points which 
will result in decreased financial gain. This balance is also available to the participants in real time. Points will 
be associated with financial quantity (1 point = 5 cents) and the youth participants will earn compensation as 
they complete the intervention as directed.  
  
The youth participants will be able to earn up to $50 for participation in the 3 and 6-month intervention and $50 
for completion of visits 4 and 5. Payment will be provided at the end of the study visits at 3 months (visit 2), 6 
months (visit 3), 12 months (visit 4), and 18 months (visit 5).  
  
Visit 1  
Visit 2  
Visit 3  
Visit 4  
Visit 5  
Months Post consent  
0  
3  
6  
12  
18  
Group 1 and 2  
-  
Up to $50  
Up to $50  
$50  
$50  
  
The table below depicts point accrual for the 6-month intervention for Group 1 (AppCoach):  
  
#  
Points per visit  
Total points  
Total payment  
Face to face/ WebEx  
visits in which 
compensation is  
received  
4 visits  
200/visit  
200*4 = 800  
800 * 0.05 = $40  
Daily weigh in  (7 
days/week)  
168 weigh ins  
(24 weeks * 7 days/per week)  
1.5 /weigh in  
168*1.5=252  
252*0.05=$12.60  
Daily text messages  (5 
days/week)  
120 text messages (5 days *  
24 weeks)  
4 /text  
120*4=480  
480*0.05=$24.00  
Weekly phone calls  (1 
call/week)  
24 calls  
20/call  
24*20=480  
480*0.05=$24  
Totals  
  
  
2012  
$100.6  
  
The table below depicts point accrual for the 6-month intervention for Group 2 (App):  
  
  
#  
Points per visit  
Total points  
Total payment  
Face to face/ WebEx  
visits in which 
compensation is 
received  
4 visits  
200/visit  
2004 = 800  
800 * 0.05 = $40  
Daily weigh in  
(7 days/week)  
168 weigh ins  
(24 weeks * 7 days/per week)  
1.5 /weigh in  
168*1.5=252  
252*0.05=$12.60  

20  
  
Protocol Version 8   
App participation 
(7 days/week)  
168 (7 days * 24 weeks)  
 5.7/daily 
interaction  
168*5.7=960  
960*0.05=$48.00  
Totals  
  
  
2012  
$100.6  
  
For Group 3 (In Clinic)    
The youth participants in this group will also earn up to $50 at 3 months (visits 4) and 6 months (visit 7) for 
participation in the 6-month intervention and $50 for completion of study visits 8 and 9. The amount of payment 
will be based upon how many visits are attended during the 6 month intervention ($16.75 per visit). Payment 
will be provided at the end of the study visits at 3 months (visit 4), 6 months (visit 7), 12 months (visit 8), and 18 
months (visit 9).   
  
The table below depicts the payment schedule for this group:  
  
  
Visit 1  
Visit 2-6  
Visit 7  
Visit 8  
Visit 9  
Months Post consent  
0  
1-5  
6  
12  
18  
Group 3  
-  
Up to $50  
Up to 
$50($16.75  
$50  
$50  
 
 
Administered 
at Visit 4  
($16.75 per  
visit  
attended)  
per visit 
attended)  
 
 
  
  
  
  
Outcomes  
  
The primary outcome will be change in zBMI and excess BMI percent over the 95th percentile 
(%BMIp95) compared to baseline, assessed at 3, 6, 12 and 18 months, both within the groups and compared 
between groups and in clinic group.  For analysis over time, the Δ%BMIp95 (BMI percentile – 95th percentile), 
which is the distance (in kg/m2) from the 95th percentile, will be utilized31.   
  
  
Secondary outcomes will include: compliance with App intervention, retention rates with scheduled 
phone calls and clinic visits, ASRI, BRIEF, Satisfaction survey, YFAS-c, fasting lab testing compared pre and 
post intervention. Collected lab studies will include:  HbA1c, Lipid Panel, AST/ALT. Each of these lab tests are 
currently recommended for routine clinical care screening every 6-12 months in obese adolescents3.   
  
  
An estimated cost analysis will be completed to determine the cost per patient to implement the 6 
month AppCoach intervention, App alone intervention and multi-disciplinary in-clinic intervention (Clinic)32. Cost 
Analysis to include: time or expenses saved compared to in-clinic (travel, missed work or school); efficiency of 
clinic and staffing needs, including appointment duration and physical space requirements, and health care 
utilization rates and costs of care33, 34.  
  
  
   

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Protocol Version 8   
Analytic Plan:  
Power and Sample Size Estimates:   
The power analysis is prepared for comparing (1) the difference in the mean change of zBMI and 
%BMIp95 between baseline, 6 months, and 18 months across App+Coach, App, and Clinic, (2) the difference 
in zBMI and %BMIp95 mean change between App+Coach and Clinic, and (3) the difference in zBMI and 
%BMIp95 mean change between App+Coach and App.  Review of the literature revealed that the majority of 
studies utilize the change in zBMI to evaluate the effectiveness of weight management interventions in 
adolescents. However, Freedman et al. and the CDC have proposed utilizing alternative metrics for weight 
change such as %BMI95 which may be more strongly associated with change in body size in adolescents. 
Therefore, both metrics were considered in the power calculation to further explore their use as outcome 
measures in youth with obesity and severe obesity.  
This study will enroll 292 patients and equally allocate into 3 groups.  All these calculations utilize an 
estimate of standard deviation of change based on the conservation of correlation of 0.5 between pre and post 
measurements within each group, based on Analysis of Variance (ANOVA) with two-sided Type I error of 5%. 
For the first study aim, the difference in the mean change of zBMI and %BMIp95 between baseline, 6 months, 
and 18 months across App+Coach, App, and Clinic, this study has at least 83% power to detect the effect size 
of 0.244 with the variance of the group means of 0.0003 for the mean change of zBMI and at least 89% power 
to detect the effect size of 0.263 with the variance of the group means of 2.903 for the mean change of  
%BMIp95.  For the second study aim, the difference in zBMI and %BMIp95 mean change between  
App+Coach and Clinic, based on two sample t-test with two-sided Type I error of 5%, this study has 88% to 
detect an effect size of 0.580 corresponds to the mean difference of pre and post change in zBMI at least 
0.040 standard deviation between the two groups and a 92% power to detect an effect size of 0.625 
corresponds to the mean difference of pre and post change in %BMIp95 at least 4.08 percent  between the two 
groups.  For the third study aim, the difference in zBMI and %BMIp95 mean change between App+Coach and 
App, based on two sample t-test with two-sided Type I error of 5%, this study has 71% power to detect an 
effect size of 0.464 corresponds to the mean difference of pre and post change in zBMI at least 0.032 standard 
deviation between the two groups and a 68% power to detect an effect size of 0.452 corresponds to the mean 
difference of pre and post change in %BMIp95 at least 2.80 percent between the two comparison groups.   
Assuming 20% dropout rate, this study will achieve the desired study power of 80% for study aim 1 and 2.  
(nQuery + nTerim 4.0 and Stata/SE 15.1).   
Statistical Analysis  
  
  
Statistical analysis:All statistical analyses were conducted in accordance with the planned study protocol.19 
We estimated that 180 participants (60 in each group) would provide 89% power (α = 0.05, 2 sided), to detect an 
effect size of 0.29 which corresponds to a difference of 4.0% %BMIp95 between the three groups. Analyses 
followed principles of intention-to-treat (ITT) and were performed in nQuery + nTerim 4.0 and Stata/SE 17 
(StataCorp, College Station, TX). A two-sided significance level of 0.05 was utilized throughout the analyses. 
Our analysis approach is based under the assumption that data are missing at random, therefore, imputation 
using last observation was carried forward, and multiple imputation based on logistic regression model (for 
BEDS-7 scores only) were utilized to account for missing data. Results from the ITT analysis using imputation 
were compared as per protocol analysis with completed data. For all outcomes a per-protocol analysis was 
conducted for: full-program (completed full 24-week intervention period), pre-COVID (completed 24-week 
intervention prior to 3/15/2020), and during COVID (completed 24-week intervention after 3/16/2020). In addition, 
to account for impacts of the intervention dosage received on each primary outcome measure we conducted an 
analysis of participants who were adherent to at least 80% of the prescribed intervention modalities versus those 
who were nonadherence. Participants' demographic characteristics and baseline anthropometric measurements 
were reported as appropriately, mean and standard deviation or median and interquartile range for continuous 
variables, and frequency and percentages for categorical variables. The change in %BMI95 between week 24 
and baseline was assessed using analysis of variance (ANOVA) for all participants via ITT, per-protocol, 
PreCOVID and during COVID. First, the %BMIp95 was analysed in log scale mixed-effects linear regression 
model to assess the association between change in %BMIp95 and demographic characteristics (sex, ethnicity, 

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obesity related co-morbidities), CED-SC, PSS, BRIEF-2, YFAS-c, and BEDS-7 scores univariately and adjusting 
for recruitment site as a covariate. Then, a multivariable mixedeffects linear regression model was utilized to 
examine the effect of the possible factors on change in %BMIp95 accounting for recruitment site, demographic 
and other measured characteristics. The results are expressed in percent change with its associated 95th% 
confidence interval and p-value.  
  
Data management and quality assurance  
  
Principles underlying our approach to quality control includes: (1) standardization of measurements; (2) 
use of clear and specific protocols for all study activities including training for data collection and processing; 
(3) validation and verification of data management procedures by using of software capable of checking for 
out-of-range values and other sources of outliers; (4) implementation of a data cleaning protocol; and (5) 
periodic meetings and progress reports to provide specific, well-documented feedback to the investigators 
concerning potential difficulties as well as sufficient follow-up to ensure that problems are resolved in a timely 
fashion. Confidentiality will be strictly maintained during all data management. Children’s Hospital of Los 
Angeles Biostatistics Core, Saban Research Institute, will follow aforementioned schemes to collect and 
manage with maintaining consistent quality and security of the study observations.  
  
Data Collection Management Plan AppCoach:  
  
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. Artificial intelligence in the app will supplement coach functions. 
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. Phone 
meetings will be documented by the coach via a secure electronic form system incorporated in the app 
database.  
  
  
Coaching:   
  
Trained clinical research coordinators will conduct semi-structured, in-person/WebEx interviews with 
each participant and all present family members using coaching session outlines developed by the research 
team. Interviews will begin with open-ended questions to prevent biased answers. Open-ended questions will 
include current health concerns and desired elements of health coaching to address these concerns during the 
intervention period. Parent/Guardian of all subjects will receive monthly calls to allow for technical difficulties to 
be remedied and to assist with improved adherence and retention. All interviews will be audio recorded  
verbatim for period evaluation of intervention fidelity. The weekly telephone call documentation will be reviewed 
monthly as well to ensure validity and identify discussion topics, themes and barriers.  
  
All survey responses that are completed will be stored in a REDCap database.  
  
Feasibility:   
CHLA: The EMPOWER Clinic at CHLA cares for obese patients one half-day each week, seeing approximately 
8 patients per week. Approximately 25% of these participants are 14-18 years of age, and ~70% of these 
should be eligible based on inclusion/exclusion criteria, yielding ~1-2 eligible participants per week. We expect 
to recruit 292 participants over a 36-month period.      
  
  
  
  
  
Randomization and Blinding:   

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Blocked randomization will be utilized, to ensure the groups are balanced in terms of number of 
subjects and the distribution of potential confounding variables. Blocked randomization will be used to ensure 
the number of eligible subjects assigned to each group is equally distributed. Block size will be blinded from the 
primary investigator performing the study.   
  
  
Potential Risks/Adverse Events and Procedures Used to Minimize the Risks  
For purposes of monitoring and reporting adverse events, the following definitions will be used:   
  
Adverse event (AE): any untoward medical occurrence that may present itself during treatment or 
administration of an intervention, and which may or may not have a causal relationship with the treatment. 
Adverse events could arise from the study (e.g., breach of confidentiality) or could arise because of the 
population under study (e.g., a mother reports extensive use of drugs).  
  
Serious adverse event (SAE): Any medical occurrence that results in death; is life-threatening; requires  
inpatient hospitalization or prolongation of existing hospitalizations; creates persistent or significant 
disability/incapacity, or a congenital anomaly/birth defect. Such an event could include suicidal ideation or 
attempted drug overdose or withdrawal, etc.  
  
Adverse events monitoring: Each participant will be evaluated for any adverse events. All events will be 
graded by their attribution (unrelated to protocol; or possibly, probably, or definitely related to protocol). Any 
event reported to the Principal Investigator or to designated research associates by the participants or their 
parents. Events will be carefully documented in a report submitted to the IRBs. The report will include a 
description of the event; when and how it was reported; any official charts, records, or documentation to 
corroborate the event or the reporting of the event; and an action plan to prevent future occurrences. All 
adverse events will be graded as mild, moderate, or severe. Any severe and/or unanticipated adverse event 
will be immediately reported to the IRBs (within 48 hours of occurrence or recognition). All adverse events will 
be summarized annually and submitted to the IRBs. Any action resulting in a temporary or permanent 
suspension of this study (e.g., IRB actions) will be reported to the funding source.   
  
Physical risks: Symptoms of fasting blood draw usually are not serious and generally resolve within a 
few minutes without treatment, by simply lying down and resting.   
  
Psychological risks: It is possible that a participant may become upset thinking about some of the 
questions or topics in this study. Trained research staff will be conducting the assessment sessions to address 
any potential incident. All participants will be informed that they are free to refuse to answer any particular 
questions or questionnaires. They will also be informed that they can withdraw from the study at any time 
without penalty. Staff will immediately report any AEs connected to the data collection to Dr. Vidmar who will 
keep a log of AEs and SAEs. Dr. Vidmar will file a written report within 24 hours of being notified to the IRB, 
whether the event relates to the project or not. As part of this process, members of the IRB committee review 
the event and determine whether the event is directly related to project procedures so that it can be determined 
whether procedures need to be modified to avoid a similar AE in the future. Whether the event is related to the 
project, we will keep a log to provide information about all AEs in annual progress reports to the IRB. Dr. 
Vidmar will monitor outcomes for AEs, and outcome information will be entered into a log for inclusion in 
reports to the IRB and NIH.   
  
Social risks: There are no added social risks from participating in this study.  
  
Legal/other risks: There are no legal risks added from participating in this study.  
  
Bullying or violence: If we suspect that participants are victims of bullying or violence at home or in their 
neighborhood, either through completion of the questionnaires or through adolescents’ report to research staff, 
we will implement the following procedures: (1) we will make adolescents aware of resources available to them 
in their communities; (2) we will work with the youths to develop a safety plan for addressing bullying or 
violence; (3) we will ascertain risk to the adolescent. If we suspect that an adolescent has been abused or 
witnessed domestic violence, we will make a report to child protective services. Children/adolescents who are 
victims of bullying or domestic violence will not be dropped from the study, unless they ask to drop out.  
Suicidal Behavior. If we suspect that participants are suicidal, we will follow the Substance Abuse and Mental 
Health Services Administration SAFE-T: Suicide Assessment Five-Step Evaluation and Triage approach to 

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determining risk and clinical response. The five steps are Identify Risk Factors, Identify Protective Factors, 
Conduct Suicide Inquiry, Determine Risk Level/Intervention, and Document (which includes intervention and 
follow-up).  As per Practice Guidelines, we will estimate suicide risk as Low, Moderate, or High. All potentially 
suicidal students will be provided an emergency plan with numbers to call, including local hospital emergency 
rooms, suicide hotlines, and research and school staff contacts. Each plan will be individually tailored to the 
needs and resources of the adolescent. Family members will be incorporated into the plan. We will be available 
to parents to work with them as to how to proceed if their child present with suicidal behavior. Adolescents who 
experience psychiatric emergencies such as suicidal behavior will not be dropped from the study, unless they 
request to terminate their participation.   
  
Protection Against Risk:  
  
Safety reviews: The Principal Investigator (Dr. Vidmar) and the IRB will review this protocol on a 
continuing basis for subject safety and include results of the review in the annual progress reports submitted to 
the funding source. The annual reports will include a list of adverse events and address: 1) whether adverse 
event rates are consistent with pre-study assumptions; 2) reasons for dropouts from the study; 3) whether all 
participants met entry criteria; and 4) whether continuation of the study is justified on the basis that additional 
data are needed to accomplish the stated aims of the study.   
  
Monitoring plan: The study’s data safety and monitoring plan will entail several components, overseen by the 
Principal Investigator (Dr. Vidmar):   
  
1.All Children’s Hospital of Los Angeles IRB policies and continuous reporting requirements will be  
 followed in conducting the proposed study. Any actions taken by the IRB as part of its continuing review  
 will be immediately reported to the funding source.    
2. 
The PIs will implement and monitor procedures to ensure that the participants provide informed  
 
consent, that parents provide consent and permission and that all data remains confidential. This will  
 
also include a rigorous data management protocol to optimize data entry, accuracy/checking, and  
 
retrieval. Data will be stored in password-protected files accessible only to the investigators and staff  
 
under their supervision. In the database, only an ID code number will identify subjects. A list linking  
 
names and other identifiers with their ID codes will be stored in a separate file with a separate  
 
password. All original paper surveys will be stored in locked file cabinets. The PI will review all data  
 
collection forms for completeness and accuracy of the data and for protocol compliance. In the case of  
 
a breach of confidentiality or other adverse event, the Principal Investigator will report the event to the  
 
IRB, and appropriate procedural changes will be implemented to prevent future breaches or adverse  
 
events.   
3. 
Internal committee. The Principal Investigator (Dr. Vidmar) and the Co-Investigators will meet  
 
quarterly to assess participant recruitment, accrual, and retention; data quality and timeliness;  
 
participant risk versus benefit; and the development of external conditions that could potentially affect  
 
the study.  Significant problems or adverse events will be reported immediately to the CHLA IRB (if  
 
relevant).    
4. 
As part of their training for the study, all study personnel who will interact with subjects will receive  
 
instruction in the completion of an adverse event reporting form. In response to any adverse event,  
 
these forms will be completed promptly and returned to the corresponding study team supervisor, who  
 
in turn will report the information to the Principal Investigator.    
Potential benefits of the proposed research to human subjects and others: This study will help researchers and 
professionals understand how mobile health interventions help adolescents with weight management. Thus, 
the benefits of this project to the individual and society greatly outweigh the risks.  
Importance of the knowledge to be gained: The proposed study tests whether mHealth interventions founded in 
addictive theory may be a cost effective and beneficial weight loss intervention for youth with obesity. This is 
important to bridge the gaps in our understanding of how to best treat obesity in this population. Our goal is to 
refine our understanding of mHealth interventions and the use of evaluating obesity through an addictive 
paradigm.  
  

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Risk-to-benefit ratio. The risks to the participants are minimal and procedures are in place to reduce the risk 
and minimize the impact of adverse events. Therefore, the potential gains of this study, which include informing 
policies and interventions addressing disease prevention and health promotion in adolescents, outweigh the 
risk of conducting this research.   
  
ClinicalTrials.gov Requirements: ClinicalTrials.gov Identifier: NCT03500835  
The project will be registered in ClinicalTrials.gov no later than 21 days after the first subject is enrolled. 
Reporting of summary results information (including adverse events) will be reported no later than 1 year after 
the completion date. The ClinicalTrials.gov registry number (also known as NCT number), brief lay public title, 
and a certification that all required submissions to ClinicalTrials.gov were completed will be provided in 
progress reports.  The PI (Dr. Vidmar) will assume responsibility for these aspects of the trial.  
  
  
  
  
References:   
1. 
van Bloemendaal L, Veltman DJ, Ten Kulve JS, et al. Brain reward-system activation in response to anticipation 
and consumption of palatable food is altered by glucagon-like peptide-1 receptor activation in humans. Diabetes 
Obes Metab. 2015;17:878-886.  
2. 
Kalon E, Hong JY, Tobin C, Schulte T. Psychological and Neurobiological Correlates of Food Addiction. Int Rev 
Neurobiol. 2016;129:85-110.  
3. 
Styne DM, Arslanian SA, Connor EL, et al. Pediatric Obesity-Assessment, Treatment, and Prevention: An 
Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017;102:709-757.  
4. 
Burrows T, Meule A. 'Food addiction'. What happens in childhood? Appetite. 2015;89:298-300.  
5. 
Gearhardt AN, Boswell RG, White MA. The association of "food addiction" with disordered eating and body mass 
index. Eat Behav. 2014;15:427-433.  
6. 
Tompkins CL, Laurent J, Brock DW. Food Addiction: A Barrier for Effective Weight Management for Obese 
Adolescents. Child Obes. 2017;13:462-469.  
7. 
Pretlow RA, Stock CM, Allison S, Roeger L. Treatment of child/adolescent obesity using the addiction model: a 
smartphone app pilot study. Child Obes. 2015;11:248-259.  
8. 
Rancourt D, Jensen CD, Duraccio KM, Evans EW, Wing RR, Jelalian E. Successful weight loss initiation and 
maintenance among adolescents with overweight and obesity: does age matter? Clin Obes. 2018.  
9. 
Majeed-Ariss R, Baildam E, Campbell M, et al. Apps and Adolescents: A Systematic Review of Adolescents' Use of 
Mobile Phone and Tablet Apps That Support Personal Management of Their Chronic or Long-Term Physical 
Conditions. J Med Internet Res. 2015;17:e287.  
10. 
Pagoto S, Schneider K, Jojic M, DeBiasse M, Mann D. Evidence-based strategies in weight-loss mobile apps. Am J 
Prev Med. 2013;45:576-582.  
11. 
Covolo L, Ceretti E, Moneda M, Castaldi S, Gelatti U. Does evidence support the use of mobile phone apps as a 
driver for promoting healthy lifestyles from a public health perspective? A systematic review of Randomized 
Control Trials. Patient Educ Couns. 2017;100:2231-2243.  
12. 
Rose T, Barker M, Maria Jacob C, et al. A Systematic Review of Digital Interventions for Improving the Diet and 
Physical Activity Behaviors of Adolescents. J Adolesc Health. 2017;61:669-677.  
13. 
Darling KE, Sato AF. Systematic Review and Meta-Analysis Examining the Effectiveness of Mobile Health 
Technologies in Using Self-Monitoring for Pediatric Weight Management. Child Obes. 2017.  
14. 
Pretlow RA. Addiction to highly pleasurable food as a cause of the childhood obesity epidemic: a qualitative 
Internet study. Eat Disord. 2011;19:295-307.  
15. 
Bohlin A, Hagman E, Klaesson S, Danielsson P. Childhood obesity treatment: telephone coaching is as good as 
usual care in maintaining weight loss - a randomized controlled trial. Clin Obes. 2017;7:199-205.  

26  
  
Protocol Version 8   
16. 
Ananthapavan J, Peeterson A, Sacks G. Paying people to lose weight: the effectiveness of financial incentives 
provided by health insurers for the prevention and management of overweight and obesity - a systematic 
review. Obes Rev. 2017.  
17. 
Job JR, Fjeldsoe BS, Eakin EG, Reeves MM. Effectiveness of extended contact interventions for weight 
management delivered via text messaging: a systematic review and meta-analysis. Obes Rev. 2017.  
18. 
Sweeting H, Smith E, Neary J, Wright C. 'Now I care': a qualitative study of how overweight adolescents managed 
their weight in the transition to adulthood. BMJ Open. 2016;6:e010774.  
19. 
Schulte EM, Gearhardt AN. Development of the Modified Yale Food Addiction Scale Version 2.0. Eur Eat Disord 
Rev. 2017;25:302-308.  
20. 
Cosco TD, Prina M, Stubbs B, Wu YT. Reliability and Validity of the Center for Epidemiologic Studies Depression 
Scale in a Population-Based Cohort of Middle-Aged U.S. Adults. J Nurs Meas. 2017;25:476-485.  
21. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24:385-396.  
22. 
Baron IS. Behavior rating inventory of executive function. Child Neuropsychol. 2000;6:235-238.  
23. 
Moilanen K. The Adolescent Self-Regulatory Inventory: The Development and Validation of a Questionnaire of 
Short-Term and Long-Term Self-Regulation2007.  
24. 
Nijs IM, Franken IH, Muris P. The modified Trait and State Food-Cravings Questionnaires: development and 
validation of a general index of food craving. Appetite. 2007;49:38-46.  
25. 
Gearhardt AN, Roberto CA, Seamans MJ, Corbin WR, Brownell KD. Preliminary validation of the Yale Food 
Addiction Scale for children. Eat Behav. 2013;14:508-512.  
26. 
Schulte EM, Potenza MN, Gearhardt AN. A commentary on the "eating addiction" versus "food addiction" 
perspectives on addictive-like food consumption. Appetite. 2016.  
27. 
Craig CL, Marshall AL, Sjostrom M, et al. International physical activity questionnaire: 12-country reliability and 
validity. Med Sci Sports Exerc. 2003;35:1381-1395.  
28. 
Clarke P, Sastry N, Duffy D, Ailshire J. Accuracy of self-reported versus measured weight over adolescence and 
young adulthood: findings from the national longitudinal study of adolescent health, 1996-2008. Am J Epidemiol. 
2014;180:153-159.  
29. 
Walpole B, Dettmer E, Morrongiello B, McCrindle B, Hamilton J. Motivational interviewing as an intervention to 
increase adolescent self-efficacy and promote weight loss: methodology and design. BMC Public Health. 
2011;11:459.  
30. 
Nguyen B, Shrewsbury VA, O'Connor J, et al. Two-year outcomes of an adjunctive telephone coaching and 
electronic contact intervention for adolescent weight-loss maintenance: the Loozit randomized controlled trial. 
Int J Obes (Lond). 2013;37:468-472.  
31. 
Freedman DS, Butte NF, Taveras EM, et al. BMI z-Scores are a poor indicator of adiposity among 2- to 19-
yearolds with very high BMIs, NHANES 1999-2000 to 2013-2014. Obesity (Silver Spring). 2017;25:739-746.  
32. 
Hamilton D, Dee A, Perry IJ. The lifetime costs of overweight and obesity in childhood and adolescence: a 
systematic review. Obes Rev. 2017.  
33. 
Finkelstein EA, Graham WC, Malhotra R. Lifetime direct medical costs of childhood obesity. Pediatrics. 
2014;133:854-862.  
34. 
Fallah-Fini S, Adam A, Cheskin LJ, Bartsch SM, Lee BY. The Additional Costs and Health Effects of a Patient Having 
Overweight or Obesity: A Computational Model. Obesity (Silver Spring). 2017;25:1809-1815.