Bridging Resources Improve the Development of Guideline-based Exercise
Condition: Obesity; Physical Activity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this pilot study is to more effectively deliver the current standard of care
      for obesity and physical activity based on current guidelines. The investigators plan to
      gather preliminary data on physician-directed Intensive Behavioral Therapy for Obesity
      (IBT-O) utilizing CardioCoachCO2 by KORR technology to measure oxygen consumption both at
      rest and during exercise to assess resting metabolic rate (RMR) and cardiorespiratory fitness
      (CRF) respectively. RMR and CRF will be incorporated into an exercise prescription through
      implementation of the CardioCoach VO2 Max App as part of a multi-level physical activity
      intervention to improve CRF and decrease obesity by acting on multiple levels of the
      socio-ecological model in a primary care setting.
    

Detailed description: 
      Experimental, One-Group Pretest-Posttest study, in which current physical activity levels and
      cardiorespiratory fitness (CRF) will be evaluated and assessed at baseline and following 6
      months of exercise conditioning. Over the course of 6 months (26 weeks) subjects will have
      physician based follow up appointments based on IBT-O by CMS criteria with the primary
      outcome of improving CRF by 1 MET, which has been associated with a 12% decrease in
      mortality. Secondary outcomes will include meeting changes in BMI consistent with CMS
      criteria of achieving a weight loss of at least 6.6 lbs (3kg) during the first six months of
      IBT in order to continue with IBT coverage. Progressing patients safely and efficiently
      toward achieving current physical activity recommendations within a sample population to
      guide future research on a larger scale. Through questionnaires the investigators will also
      gather data on Stages of Change Readiness, osteoarthritis of the knee and other
      weight-bearing joints, and overall Quality of Life. Subjects will be approved by their
      primary care physician prior to study participation. Based on American College of Sports
      Medicine (ACSM's) 2015 preparticipation health screening guidelines, if medical clearance is
      required then subjects will need to make an appointment with their PCP for exercise clearance
      prior to subjects' first week of participation and prior to any exercise testing. Information
      collected will included demographic (age, gender, race, occupation, current employment
      status) and co-morbid medical conditions such as hypertension, diabetes, coronary artery
      disease, renal disease, heart failure, etc. or any other significant illness.

      On the first day of testing subjects after an overnight fast of at least 12 hours for
      determination of RMR through indirect calorimetry. After completing the RMR assessment,
      subjects will complete the following instruments: assessment of current physical activity
      level, Stage of Readiness to Change, personal health goals, screened by symptom assessment
      and physical examination for osteoarthritis of the knee and other weight-bearing joints,
      screening for depression and overall Quality of Life through the application of a
      questionnaires in a primary care setting.

      On the 2nd day subjects will perform a symptom limited cardiopulmonary exercise (CPX) testing
      on a treadmill using a modified Balke protocol. Subjects will each be provided with their own
      personal heart rate monitor. The initial graded exercise test will be performed with the
      heart rate monitor being worn. Subjects will keep their own heart rate monitor during the
      study, and they will wear them during their workouts so that the app can keep them in their
      target heart rate zone. They will also wear the monitors during their 6 month graded exercise
      test. After completion of the CPX, Subjects will be instructed on how to download and utilize
      the CardioCoach VO2 Max app available on Smartphones which is compatible with Polar H10 Heart
      rate monitor system.

      Subjects will be provided with access to the YMCA within their community to implement their
      exercise prescription.

      This IBT-O model utilizing CardioCoachCO2 technology to improve physical activity, will
      follow the requirements developed by CMS for coverage of an IBT for Obesity

        1. One face-to-face visit every week for the first month,

        2. One face-to-face visit every other week for months 2-6,

        3. At the six-month visit, a reassessment of Obesity and CRF through CPX. A healthy meal
           plan has been included as part of standard of care based on CMS IBT guidelines. Subjects
           will be counseled on the development of a healthy meal plan. This healthy meal plan will
           incorporate each subject's RMR as the foundation for caloric requirements. In addition
           to being counseled on the development of a healthy meal plan, subjects will be educated
           and counseled on Intermittent Fasting (IF).

      During the study, the investigators will monitor fitness indicators (physical activity level,
      weight, BMI, BP, resting HR, VO2Peak, VO2Max, RER, Test time, METpeak, HRmax, HRrecovery,
      calories burned) and adherence (number of sessions performed at YMCA/month compared goal of
      12 exercise sessions/4 weeks), in addition to physical activity performed outside of the
      YMCA. The Co-PI and subject will work together to determine the subject's desired mode and
      intensity of physical activity, and then construct an exercise prescription to meet current
      AACE and ACSM physical activity guideline recommendations.
    

Intervention name(s): Exercise Prescription
Intervention type(s): Behavioral
Intervention description(s): The CardioCoach Vo2Max app allows the physician to upload an individual's Vo2 Max and resting metabolic rate results to the app which will allow each subject to view those results in the context of workout zones, goals, and energy balance. The app shows time spent aerobic versus anaerobic, and the actual number of calories burned during a workout and post-workout. It will also show what fuel source (Fats vs Carbs) are being used in real time during your workouts. Subjects can be guided through their workouts utilizing voice coaching to keep you in your customized zones. Additionally, the app accommodates a quick add of calories directly to the app to track calories consumed vs calories burned.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiorespiratory Fitness; Intensive Behavioral Therapy for Obesity; Exercise Prescription