A Remote Delivered Lifestyle Therapeutics Program
Condition: Body Weight Changes; Weight Loss; Healthy Diet; Obesity
MeSH terms: Body Weight; Weight Loss; Body Weight Changes
Study type: Interventional

Summary: 
      Heart disease is the leading cause of death in the United States. The overall risk for heart
      disease is a composite measure of various modifiable factors including blood pressure,
      cholesterol, and tobacco use; which are exacerbated by a sedentary lifestyle, unhealthy diet,
      and being overweight. Approximately 32% of the adult U.S. population has high blood pressure
      and 46% of them have uncontrolled hypertension. Successful management of high blood pressure
      and other cardiovascular risk is a complex process that requires significant lifestyle
      changes but adopting and adhering to these changes is challenging. A promise approach to
      overcoming these challenges is utilizing health coaching. The purpose of this research study
      is to compare at home devices for blood pressure and weight measurements (DEV) group compared
      to not using any at home devices Group (NODEV). Both groups will be supported throughout this
      study by meeting with obesity medicine doctor monthly in office and have a virtual health
      coaching visits throughout the study duration.
    

Detailed description: 
      Baseline Assessment Participants attend a baseline assessment with a study Health Coach that
      includes an overview and explanation of the study, the completion of several surveys that
      involve questions related to your overall health and demographics (age, race, etc). In
      addition, body weight using a scale and resting blood pressure using a blood pressure cuff.
      During participants will be asked to download the DiscoverHealth app which will be used to
      track daily nutritional information (food and drinks) and for health coaching sessions.

      Groups Participants will then be randomly assigned to a device group (DEV) or a no device
      group (NODEV).

      Control Group If randomly assigned to the NO DEV Group, participants will be asked to
      download the DiscoverHealth® app and daily input their nutritional information into the app.
      This will occur at the baseline assessment. Monthly participants will be asked to attend the
      Sleep Health Clinic to obtain body weight and blood pressure.

      Intervention Group

      Regardless of randomization (NODEV OR DEV) participants will be be asked to input their daily
      nutritional information (food) into the DiscoverHealth® app which will be used by the medical
      doctor and health coach.

      Physical Activity Recommendations:

      They will be asked to exercise in accordance with obesity medicine doctors recommendations
      which may be recommendations like obtaining 20 minutes per day of walking with gradual
      progression to at least 60 minutes per day and achieve 10,000 steps/day. These
      recommendations are consistent with the guidelines of national organizations.

      No Device Group (NODEV):

      Medical Doctor Visits:

      If participants are randomized to the NODEV group they will individually meet at the Sleep
      health Clinic and meet with the obesity medical doctor monthly (1-6) with each visit lasting
      approximately 15 - 45 minutes per visit. During the first visit each subject will be provided
      with individualized targets for the number of calories to consume per day and associated
      macronutrient ratios (i.e. percent of calories from protein, fat, and carbohydrates). They
      will be asked to follow diet recommendations which emphasizes fruits, vegetables, and low-fat
      dairy foods and reduced consumption of saturated fat, total fat, and cholesterol along with
      whole grains, poultry, fish, and nuts. The obesity medicine doctor will prescribe calories.
      At each visit body weight and blood pressure will be assessed and recorded, and the medical
      doctor will review and discuss each subject's current diet, physical activity plan, body
      weight and blood pressure changes.

      Health Coaching Visits:

      Months 1-3: Following the initial baseline visit they receive weekly individualized video
      health coaching sessions through the video conference feature of the DiscoverHealth® app on
      your Apple iPhone® or Android® smart phone. These health coaching sessions will be separate
      video conferences with the research team's Health Coach (HC). During these sessions, they
      will receive weekly educational online modules focusing on nutrition and fitness as well as
      education on way to manage your high blood pressure. Each week, the HC will review their
      progress including calories per day, macronutrient ratio, and make changes to your meal plan
      if needed. Additionally, the HC will discuss the physical activity program and progress it as
      needed (i.e. increase the number of steps per day). Each health coaching session will last
      approximately 20 minutes each resulting in a time subject commitment of 40 minutes per week.
      During all sessions, participants will have time to express any concerns or questions you may
      have.

      Months 4-6: All health coaching session information and follow up will remain the with the
      health coach except participants will receive bi-weekly video health coaching sessions
      through the video conference feature of the DiscoverHealth® app on your Apple iPhone® or
      Android® smart phone. They will meet 6 times with the health coach during these months.

      Device Group (DEV):

      Months 1-3: Following the initial baseline visit participants will receive weekly video
      health coaching sessions through the video conference feature of the DiscoverHealth® app on
      their Apple iPhone® or Android® smart phone. These health-coaching sessions will be separate
      video conferences with the research team's HC. During these sessions, they will receive
      weekly educational online modules focusing on nutrition, fitness, behavior modification, and
      support building as well as education on ways to manage their blood pressure. Each week, they
      will be asked to weigh themselves and take their blood pressure using the devices provided,
      daily. They will meet with the HC each week to review your progress including calories per
      day, macronutrient ratio, and make suggestions to their meal plan if needed. Additionally,
      the HC will discuss the physical activity program and progress it as needed (i.e. increase
      the number of steps per day). Each health coaching session with HC will last approximately 20
      minutes each resulting in a time subject commitment of 40 minutes per week. During all
      sessions, they will have time to express any concerns or questions you may have. They will
      meet 12 times with the registered dietitian during these months.

      Months 4-6: All health coaching session information and follow up will remain the with the HC
      except they will receive bi-weekly individualized video health coaching sessions through the
      video conference feature of the DiscoverHealth® app on their Apple iPhone® or Android® smart
      phone. Each week, they will still be asked to weigh themselves and take their blood pressure
      using the devices provided, daily. They will meet 6 times with the health coach and during
      these months.
    

Intervention name(s): Video Conferencing Health Coaching with devices; Video Conferencing Health Coaching with no devices
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Devices; No Devices
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants were randomized in a balanced fashion and stratified by sex into either one of the two intervention groups no device (NODEV) group or a device (DEV) group.
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: telehealth; video conferencing; blood pressure; lipids; weight loss; usual care; obesity medicine