A Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight Loss App
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Kurbo is a health and fitness app that is targeted toward the pediatric population. It
      utilizes games and activities to educate children about healthy eating, portion control/size
      and exercise. It allows for food tracking by using servings of macronutrients and food groups
      and sets goals for achieving a healthy BMI through modification of diet intake. In addition
      to being created solely for children and adolescents, a unique feature of this app is an
      option to speak with a personal health coach on a regular basis to obtain feedback, advice
      and encouragement. Studies suggest that weight loss outcomes are best with more frequent
      contact hours but most weight loss clinics, including ours, are not equipped to meet with
      patients on a weekly basis or even monthly basis. The personal coaching aspect of Kurbo is
      expected to improve outcomes by increasing user access to feedback and advice.

      The purpose of this pilot study is to assess the feasibility, compliance with and effects of
      a pediatric centered weight loss app on BMI z-scores in a group of children and adolescents
      in a pediatric weight management program. The investigators will assess the impact of the app
      as an adjunct to current weight management therapy, both with and without the personal health
      coach (PHC) option.
    

Detailed description: 
      As a result of childhood obesity and its comorbidities, this generation of children might be
      the first to not outlive its parents. The national prevalence of adolescent obesity has
      increased from 5% to 21% over the last five decades. Even more discouraging is that youth are
      being afflicted with the same obesity-related comorbidities that are affecting adults.
      Conditions such as type 2 diabetes, hypertension, non-alcoholic fatty liver disease,
      dyslipidemia, metabolic syndrome, and sleep apnea are being diagnosed in children at younger
      and younger ages.

      Lifestyle modification continues to be the cornerstone of treatment for obesity and its
      associated conditions. The basic concept behind lifestyle modification is a balance of
      caloric intake and caloric output. Lifestyle modification alone has shown to result in on
      average 5-10% weight loss over a 6 month period in adults or a 1-2 kg weight loss over 6-12
      months. In pediatrics, weight loss is generally not used a marker of success given that the
      child is still growing linearly in most cases. Thus, changes in BMI and/or BMI z-score are
      utilized to measure success. Pediatric studies cite improvements in BMI z-score ranging from
      0.004 to 0.42 with most studies averaging a 0.1-0.2 decrease in BMI z- score over 6 to 12
      months.

      The pediatric weight management program at Baystate Medical Center sees children and
      adolescents from the ages of 2-20 years. Standard care for the program involves monthly
      visits with a physician (either a general pediatrician or pediatric endocrinologist) or a
      nurse practitioner in addition to visits every 3 months with a registered dietitian. During
      each visit, food and activity recalls are conducted and 1-2 goals are made with the patient
      and their caregivers that focus on improving the quality and quantity of the patient's intake
      as well as increasing physical activity. Goals are personalized and are adjusted to meet the
      social, psychological, financial and motivational needs of the patient.

      Sixty four percent of Americans own smartphones. The use of smartphone apps for health and
      wellness has sky rocketed as more sophisticated and user friendly apps are being developed to
      assist with weight loss, healthy eating, exercise and tracking food and activity. Digital
      tools can allow one to be constantly aware of how much they are eating and expending, which
      may result in an improvement in overall weight loss. In adults weight loss of 1-5 kg over a 6
      month period is achievable using tools such as food log apps. Such apps are generally suited
      for adults only and the few weight loss apps targeted toward the pediatric population have
      not been validated by weight loss programs. Apps that are available for younger patients have
      been criticized for containing inadequate expert recommended strategies for achieving a
      healthy weight, lack of goal setting, and poor provision of education.

      Kurbo is a health and fitness app that is targeted toward the pediatric population. It
      utilizes games and activities to educate children about healthy eating, portion control/size
      and exercise. It allows for food tracking by using servings of macronutrients and food groups
      and sets goals for achieving a healthy BMI through modification of diet intake. In addition
      to being created solely for children and adolescents, a unique feature of this app is an
      option to speak with a personal health coach on a regular basis to obtain feedback, advice
      and encouragement. Studies suggest that weight loss outcomes are best with more frequent
      contact hours but most weight loss clinics, including ours, are not equipped to meet with
      patients on a weekly basis or even monthly basis. The personal coaching aspect of Kurbo is
      expected to improve outcomes by increasing user access to feedback and advice.

      The purpose of this pilot study is to assess the feasibility, compliance with and effects of
      a pediatric centered weight loss app on BMI z-scores in a group of children and adolescents
      in a pediatric weight management program. The investigators will assess the impact of the app
      as an adjunct to current weight management therapy, both with and without the personal health
      coach (PHC) option.

      The Primary aim is to assess 3 month compliance with the Kurbo app as well as the Kurbo app
      and PHC by a group of morbidly obese children and adolescents in a weight management program.
      The investigators hypothesize that compliance with the Kurbo app and Kurbo app plus PHC will
      be better than known compliance of the investigators standard of care group. The Secondary
      aim is to assess the effect of the Kurbo app as well as the Kurbo app and PHC on 3 month
      change in BMI-z score among morbidly obese children and adolescents undergoing a weight
      management program. The hypothesis is that the use of the Kurbo app and Kurbo app plus a
      personal health coach will result in a greater reduction in BMI z-score over 3 months than
      known change in a standard care group and that the use of the app and personal health coach
      will result in a greater reduction in BMI z-score over 3 months than with the use of the app
      without the personal health coach.
    

Intervention name(s): Kurbo; Personal Health Coach
Intervention type(s): Device; Device
Intervention description(s): health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits; weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: body mass index change; weight loss; patient compliance