<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/NCT02201069</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00087322</org_study_id>
    <nct_id>NCT02201069</nct_id>
  </id_info>
  <brief_title>My Health Coach Study</brief_title>
  <official_title>My Health Coach Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The &quot;My Health Coach Study&quot; seeks to determine if health coaching by a medical assistant can&#xD;
      help patients have better sleep, a better diet, be more physically active or lose weight,&#xD;
      according to the recommendation of their health care provider.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to determine whether medical assistants (MAs) can assist primary care&#xD;
      providers to achieve healthier lifestyles via better sleep, food choices, weight loss and/or&#xD;
      increased physical activity in their patients. The hypothesis driving this research is that&#xD;
      health coaching can be done by existing medical support staff to facilitate healthy&#xD;
      lifestyles in a primary care setting. Coaching can maximize the health of the patient&#xD;
      population in a cost-effective way if the coaching service is integrated into primary care&#xD;
      clinics with minimal capital investment at the outset. A major focus will be on behaviors&#xD;
      associated with weight management since this is the most common health issue in the U.S.&#xD;
      today. This method, if successful, should be easily adaptable to other health behaviors and&#xD;
      in most any medical practice that seeks to improve the health of its patient base in a&#xD;
      cost-effective way.&#xD;
&#xD;
      In order to achieve a change in health behaviors, and especially weight loss, regular&#xD;
      follow-up contacts are needed. Previous research has shown health coaching to be effective,&#xD;
      but this has utilized programs that &quot;add on&quot; to the existing clinic structure. This type of&#xD;
      coaching model is difficult to sustain. Utilizing existing staff for health coaching is a&#xD;
      method we propose to more fully integrate this service into primary care clinics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet quality</measure>
    <time_frame>12 weeks</time_frame>
    <description>adherence to USDA recommendations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>12 weeks</time_frame>
    <description>adherence to physical activity recommendations of 30 min/day of at least moderate activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>12 weeks</time_frame>
    <description>Better sleep habits</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life</measure>
    <time_frame>12 weeks</time_frame>
    <description>stress, fatigue, self-efficacy, motivation</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>health coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of health coaching using weekly contact in the first month and biweekly contacts in months 2-3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>health coaching</intervention_name>
    <arm_group_label>health coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults age 21 and over&#xD;
&#xD;
          -  referred by primary care physician for health coaching&#xD;
&#xD;
          -  have telephone for follow-up&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or trying to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Briarwood Family Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>August 18, 2016</last_update_submitted>
  <last_update_submitted_qc>August 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Zora Djuric</investigator_full_name>
    <investigator_title>Research Professor</investigator_title>
  </responsible_party>
  <keyword>nutrition</keyword>
  <keyword>physical activity</keyword>
  <keyword>sleep</keyword>
  <keyword>weight loss</keyword>
  <!-- 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/NCT02201069
org study id: HUM00087322
nct id: NCT02201069
lead sponsor: 
has dmc: No
The "My Health Coach Study" seeks to determine if health coaching by a medical assistant can
      help patients have better sleep, a better diet, be more physically active or lose weight,
      according to the recommendation of their health care provider.
The aim of the study is to determine whether medical assistants (MAs) can assist primary care
      providers to achieve healthier lifestyles via better sleep, food choices, weight loss and/or
      increased physical activity in their patients. The hypothesis driving this research is that
      health coaching can be done by existing medical support staff to facilitate healthy
      lifestyles in a primary care setting. Coaching can maximize the health of the patient
      population in a cost-effective way if the coaching service is integrated into primary care
      clinics with minimal capital investment at the outset. A major focus will be on behaviors
      associated with weight management since this is the most common health issue in the U.S.
      today. This method, if successful, should be easily adaptable to other health behaviors and
      in most any medical practice that seeks to improve the health of its patient base in a
      cost-effective way.

      In order to achieve a change in health behaviors, and especially weight loss, regular
      follow-up contacts are needed. Previous research has shown health coaching to be effective,
      but this has utilized programs that "add on" to the existing clinic structure. This type of
      coaching model is difficult to sustain. Utilizing existing staff for health coaching is a
      method we propose to more fully integrate this service into primary care clinics.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Weight loss
time frame: 12 weeks
measure: Diet quality
time frame: 12 weeks
description: adherence to USDA recommendations
measure: Physical activity
time frame: 12 weeks
description: adherence to physical activity recommendations of 30 min/day of at least moderate activity.
measure: Sleep
time frame: 12 weeks
description: Better sleep habits
measure: Quality of Life
time frame: 12 weeks
description: stress, fatigue, self-efficacy, motivation
arm group label: health coaching
arm group type: Experimental
description: 12 weeks of health coaching using weekly contact in the first month and biweekly contacts in months 2-3.
intervention type: Behavioral
intervention name: health coaching
arm group label: health coaching
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Zora Djuric
investigator title: Research Professor