W8Loss2Go: mHealth Weight Management Strategy

Background and Rationale: About one in five 12-18 year-olds in the U.S. are obese. 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. Since mHealth interventions have been successful in the treatment of other addictions,
the investigators hypothesize that mHealth technologies which are rooted in behavioral theory
could be effective to promote weight loss in some individuals.

Dr. Robert Pretlow, together with E-Health International, created a weight loss intervention
via an iPhone application (W8Loss2Go), based on the addiction treatment approach of staged,
incremental withdrawal from problem foods, snacking/grazing, and excessive amounts of foods
at meals. The W8Loss2Go application helps participants address their dependence on specific
problem foods prior to addressing the amount of food consumed. A secondary focus of the
application is to increase the amount of health provider-patient interaction outside of
clinic based face-to-face-sessions in a cost-effective manner. Initial pilot studies in obese
adolescents in a community setting showed success in improving these problem behaviors and
improving BMI.

Intervention: The investigators 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.

Hypothesis: The investigators hypothesize that participants who display addictive behaviors
will respond well the mHealth intervention and will be able to withdraw from problem foods
and eliminate snacking and excessive amounts eaten at meals, and will therefore show
significant decrease in BMI z score from first to last visit.

Specific Aim 1: Determine if participants utilizing the app can stop eating certain
self-identified problem foods.

Specific Aim 2: Determine if participants utilizing the app can reduce the amounts
(portion-size and frequency) of foods that they consume in large quantities.

Study Design: New EMPOWER patients complete the Yale Food Addiction Study for Children
(YFAS-c), a validated 25 item instrument designed to identify addictive behaviors related to
food. Patients with more than two positive criteria on the YFAS-C will be recruited for
participation in the W8Loss2Go study. Enrolled subjects and their parents will complete the
Eating Behaviors Questionnaire (EBQ-Merlo 2009), and then receive the app, an iPhone 5S (if
needed), a wireless body weight scale, and a wireless food scale. Over the next 6 months,
subjects will proceed through all parts of the app program (problem food withdrawal, snacking
control and withdrawal from excessive portions) and receive weekly phone calls from the study
coordinator, who will be monitoring app usage and providing motivation. During the six months
study period, subjects will return to the EMPOWER clinic for a three month weight check and
face-to face meeting with their mentor. After the study period, participants will again
complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home
use of the mHealth technology Study Population: Twenty obese 12-18 year old adolescents will
be recruited from new patients referred to the CHLA EMPOWER Clinic.

Control Population: The investigators will utilize historical controls using newly referred
patients to the EMPOWER clinic who score negative on the YFAS-c.

Methods of Data 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.

Significance: This study will evaluate the feasibility of implementing a mHealth intervention
in a large clinic setting and further explore the role of food addiction specific weight loss
therapies as an effective and sustainable weight management strategy for children and
adolescents.

Inclusion Criteria:

1. Age 12-18 years

2. Patients referred to EMPOWER

3. Positive screen on the Yale Food Addiction Scale for Children

4. Participant will not be leaving the country during the study duration.

Exclusion Criteria:

1. Obesity comorbidities 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