<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03283618</url>
  </required_header>
  <id_info>
    <org_study_id>824851-2</org_study_id>
    <secondary_id>8UL1GM118979-02</secondary_id>
    <nct_id>NCT03283618</nct_id>
  </id_info>
  <brief_title>Implementation of Medical Weight Management by Telemedicine</brief_title>
  <official_title>Implementation of Medical Weight Management by Telemedicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California State University, Long Beach</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>inHealth Medical Services, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>California State University, Long Beach</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As the prevalence and associated healthcare costs of obesity continue to increase, the need&#xD;
      for obesity treatments that contribute to weight loss maintenance are needed. Through the&#xD;
      functionality of a smart device, telehealth can provide quality healthcare to individuals of&#xD;
      different socioeconomic communities, expand healthcare access, as well as reduce overall&#xD;
      healthcare costs. This research program will uncover the effects of a 12-week commercially&#xD;
      available telehealth-based weight management program (inHealth Medical Services, Inc.) on&#xD;
      body weight, blood pressure, and steps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Solutions for convenient and cost saving healthcare services are needed in order to control&#xD;
      costs to the public. Currently, there is a gap in weight management research involving&#xD;
      telemedicine as a potential tool for obesity treatment. The use of technology will promote&#xD;
      general health awareness, dietary intake and exercise practices, as well as patient&#xD;
      compliance. Successful weight management program components learned from hallmark clinical&#xD;
      trials include: frequent contact with the patient, frequent measurements, patient education,&#xD;
      and monitoring tools to help alleviate barriers to adherence.&#xD;
&#xD;
      The purpose of this study is to examine the effect of a fully on-line, 12-week, medically&#xD;
      monitored weight management program on obesity-related health outcomes. These obesity related&#xD;
      outcomes include body weight, body fat, blood pressure and physical activity. Our central&#xD;
      hypothesis is that this video conferencing (video conference similar to skype) platform will&#xD;
      significantly improve health outcomes of quality of life, and participant adherence when&#xD;
      coupled with a multidisciplinary team. The primary objective of this study is to determine&#xD;
      the effect of a fully on-line medical weight management program on cardiometabolic outcome&#xD;
      measures directly associated with obesity. Data collection will be conducted prospectively&#xD;
      with all patient information and data will be secured through a HIPAA compliant server&#xD;
      database accessible only by the research team.&#xD;
&#xD;
      There are two specific aims proposed for this fully on-line 12-week medically monitored&#xD;
      weight management program: 1) to investigate the changes in body weight in response to health&#xD;
      coaching via telemedicine using the inHealth Medical Services, Inc, online program structure&#xD;
      and 2) to examine changes in steps and dietary eating quality. The central hypothesis is that&#xD;
      telehealth functions will improve health outcomes, quality of life, behaviors, and&#xD;
      participant adherence.&#xD;
&#xD;
      The public health benefits of weight management via telehealth are vast. Through the&#xD;
      functionality of a mHealth (mobile health) devices, quality health coaching can be provided&#xD;
      to individuals in different socioeconomic communities, expand healthcare access, as well as&#xD;
      reduce overall healthcare costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2015</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All subjects were randomized in a balanced fashion and stratified by sex into either one of the two groups video conferencing or a control group.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Following baseline visits, participants were randomized to a video conference or control groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight loss (kg)</measure>
    <time_frame>Change in body weight between week 0 and week 12</time_frame>
    <description>The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of daily step average per day by group.</measure>
    <time_frame>Change in average steps per day between week 0 and week 12</time_frame>
    <description>The investigators examined steps per day and averaged them every week. The investigators then graphed each time point (weeks) and presented them as adjusted average and standard deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of resting systolic and diastolic blood pressure average per day by group.</measure>
    <time_frame>Change in systolic and diastolic blood pressure per day between week 0 and week 12</time_frame>
    <description>The investigators examined resting blood pressure per day and averaged systolic and diastolic blood pressure every week. The investigators then graphed each time point (weeks) and presented them adjusted average and standard deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change from pre to post intervention.</measure>
    <time_frame>Pre and Post (a 12 week study)</time_frame>
    <description>The investigators examined quality of life measured via survey at week 0 and at week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Quality change from pre to post intervention.</measure>
    <time_frame>Pre and Post (a 12 week study)</time_frame>
    <description>The investigators examined dietary quality measured via survey at week 0 and at week 12.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <condition>Telemedicine</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) as well as caloric and step goals, but no health coaching. They will complete the same pre- and post-intervention measurements and consultations with the medical doctor and registered dietitian.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Conference-based Health Coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The video conference-based health coaching group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) meet the medical doctor at baseline and at 12 weeks via the Amwell® app using their smartphone. The participants will receive health coaching by meeting weekly (12 times) with the registered dietitian (RD) to discuss behavior modification, exercise, and nutrition goals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video Conferencing Group</intervention_name>
    <arm_group_label>Video Conference-based Health Coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria include the following: participants must be ambulatory, be fluent&#xD;
             in English spoken and written at a high-school age level, have a BMI of &gt; 30 kg/m2,&#xD;
             have been weight stable or gaining weight for the last 6 months, Weigh less than 396&#xD;
             pounds, have voluntarily signed and dated an informed consent form. Fluent in English&#xD;
             spoken and written at a high-school level, live a sedentary lifestyle defined as &lt;&#xD;
             7,000 steps per day. Have access to an Apple® iPhone smart phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria includes the following: participants has stated an immunodeficiency&#xD;
             disorder, kidney disease, history of uncontrollable blood pressure, heart attack&#xD;
             within the last 3 months, presence of partial or full artificial limb, has known&#xD;
             dementia, brain cancer, eating disorders, history of significant neurological or&#xD;
             psychiatric disorder or any other psychological condition, currently taking&#xD;
             medications/dietary supplements/substances that could profoundly modify metabolism or&#xD;
             body weight, has undergone major surgery, less than 4 weeks prior to enrollment in the&#xD;
             study, or is actively losing weight. Although not anticipated for this study&#xD;
             population, women cannot be or suspect they may be pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia Gray, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>California State University, Long Beach</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>California State University, Long Beach</investigator_affiliation>
    <investigator_full_name>Michelle Kulovitz Alencar</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Weight loss</keyword>
  <keyword>Video conferencing</keyword>
  <keyword>Health coaching</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>mHealth</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is not yet known if there will be a plan to make IPD available.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283618
org study id: 824851-2
secondary id: 8UL1GM118979-02
nct id: NCT03283618
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
As the prevalence and associated healthcare costs of obesity continue to increase, the need
      for obesity treatments that contribute to weight loss maintenance are needed. Through the
      functionality of a smart device, telehealth can provide quality healthcare to individuals of
      different socioeconomic communities, expand healthcare access, as well as reduce overall
      healthcare costs. This research program will uncover the effects of a 12-week commercially
      available telehealth-based weight management program (inHealth Medical Services, Inc.) on
      body weight, blood pressure, and steps.
Solutions for convenient and cost saving healthcare services are needed in order to control
      costs to the public. Currently, there is a gap in weight management research involving
      telemedicine as a potential tool for obesity treatment. The use of technology will promote
      general health awareness, dietary intake and exercise practices, as well as patient
      compliance. Successful weight management program components learned from hallmark clinical
      trials include: frequent contact with the patient, frequent measurements, patient education,
      and monitoring tools to help alleviate barriers to adherence.

      The purpose of this study is to examine the effect of a fully on-line, 12-week, medically
      monitored weight management program on obesity-related health outcomes. These obesity related
      outcomes include body weight, body fat, blood pressure and physical activity. Our central
      hypothesis is that this video conferencing (video conference similar to skype) platform will
      significantly improve health outcomes of quality of life, and participant adherence when
      coupled with a multidisciplinary team. The primary objective of this study is to determine
      the effect of a fully on-line medical weight management program on cardiometabolic outcome
      measures directly associated with obesity. Data collection will be conducted prospectively
      with all patient information and data will be secured through a HIPAA compliant server
      database accessible only by the research team.

      There are two specific aims proposed for this fully on-line 12-week medically monitored
      weight management program: 1) to investigate the changes in body weight in response to health
      coaching via telemedicine using the inHealth Medical Services, Inc, online program structure
      and 2) to examine changes in steps and dietary eating quality. The central hypothesis is that
      telehealth functions will improve health outcomes, quality of life, behaviors, and
      participant adherence.

      The public health benefits of weight management via telehealth are vast. Through the
      functionality of a mHealth (mobile health) devices, quality health coaching can be provided
      to individuals in different socioeconomic communities, expand healthcare access, as well as
      reduce overall healthcare costs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All subjects were randomized in a balanced fashion and stratified by sex into either one of the two groups video conferencing or a control group.
primary purpose: Other
masking: Single (Participant)
masking description: Following baseline visits, participants were randomized to a video conference or control groups.
measure: Body weight loss (kg)
time frame: Change in body weight between week 0 and week 12
description: The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).
measure: Comparison of daily step average per day by group.
time frame: Change in average steps per day between week 0 and week 12
description: The investigators examined steps per day and averaged them every week. The investigators then graphed each time point (weeks) and presented them as adjusted average and standard deviation.
measure: Comparison of resting systolic and diastolic blood pressure average per day by group.
time frame: Change in systolic and diastolic blood pressure per day between week 0 and week 12
description: The investigators examined resting blood pressure per day and averaged systolic and diastolic blood pressure every week. The investigators then graphed each time point (weeks) and presented them adjusted average and standard deviation.
measure: Quality of Life change from pre to post intervention.
time frame: Pre and Post (a 12 week study)
description: The investigators examined quality of life measured via survey at week 0 and at week 12.
measure: Dietary Quality change from pre to post intervention.
time frame: Pre and Post (a 12 week study)
description: The investigators examined dietary quality measured via survey at week 0 and at week 12.
arm group label: Control Group
arm group type: No Intervention
description: The control group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) as well as caloric and step goals, but no health coaching. They will complete the same pre- and post-intervention measurements and consultations with the medical doctor and registered dietitian.
arm group label: Video Conference-based Health Coaching
arm group type: Experimental
description: The video conference-based health coaching group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) meet the medical doctor at baseline and at 12 weeks via the Amwell® app using their smartphone. The participants will receive health coaching by meeting weekly (12 times) with the registered dietitian (RD) to discuss behavior modification, exercise, and nutrition goals.
intervention type: Behavioral
intervention name: Video Conferencing Group
arm group label: Video Conference-based Health Coaching
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Virginia Gray, PhD, RD
role: Principal Investigator
affiliation: California State University, Long Beach
responsible party type: Principal Investigator
investigator affiliation: California State University, Long Beach
investigator full name: Michelle Kulovitz Alencar
investigator title: Assistant Professor
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: Undecided
ipd description: It is not yet known if there will be a plan to make IPD available.