W8Loss2Go: mHealth Weight Management Strategy
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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 withdrawal from problem foods, snacking, and excessive amounts at
      meals. The investigators will test whether this intervention will reduce body mass index
      (BMI), help subjects identify and withdraw from "problem foods", eliminate snacking, and
      reduce the amounts of foods consumed at home meals.
    

Detailed description: 
      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.
    

Intervention name(s): W8Loss2Go
Intervention type(s): Device
Intervention description(s): The participants 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. 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Obesity; Food Addiction; Mobile Health (mHealth); Weight Management