<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/NCT04420936</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_00132802</org_study_id>
    <secondary_id>1R18DK123372-01A1</secondary_id>
    <nct_id>NCT04420936</nct_id>
  </id_info>
  <brief_title>Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program</brief_title>
  <acronym>MAINTAIN PRIME</acronym>
  <official_title>Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program MAINTAIN PRIME (Promoting Real (World) IMplEmentation Through Care Teams).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</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>
      Many people struggle not only to lose weight through changes in diet and physical activity,&#xD;
      but also to maintain weight loss once they have achieved it. In a previous study, our team&#xD;
      designed and deployed a weight maintenance intervention that was delivered through the&#xD;
      patient portal of an electronic health record (EHR) and found that patients who tracked their&#xD;
      weight, diet, and physical activity and also received coaching had better success with&#xD;
      maintaining recent intentional weight loss than patients who tracked but did not receive&#xD;
      coaching. The investigators propose to repeat the intervention in a new health care system&#xD;
      and train routine health care staff (e.g., medical assistants and nurses) to be coaches, a&#xD;
      more sustainable model that will allow ongoing intervention delivery after the proposed study&#xD;
      ends.&#xD;
&#xD;
      This is a pragmatic randomized clinical Trial with percent weight change at 24 months as the&#xD;
      primary outcome. This will be a 2-arm randomized trial that compares the MAINTAIN PRIME&#xD;
      lifestyle coaching intervention to a control tracking intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is a major health problem in the United States and associated with increased risk of&#xD;
      diabetes. While many behavioral interventions have led to successful short-term weight loss,&#xD;
      very few programs focus on weight loss maintenance after intentional loss, and fewer still&#xD;
      are applicable to routine health care settings. There is a great need for interventions that&#xD;
      can assist with long-term maintenance of healthy body weight and be sustainably integrated&#xD;
      into existing health care teams. The investigators have developed and tested an innovative&#xD;
      weight loss maintenance intervention - Maintaining Activity and Nutrition through&#xD;
      Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) - delivered through the&#xD;
      electronic health record (EHR) to help patients maintain recent intentional weight loss and&#xD;
      successful lifestyle strategies.&#xD;
&#xD;
      The investigators have conducted and published a randomized clinical trial of MAINTAIN-pc at&#xD;
      the University of Pittsburgh and found that participants who received EHR tracking tools and&#xD;
      personalized coaching had significantly lower weight regain at 24 months (primary outcome)&#xD;
      than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly&#xD;
      available health information technology (HIT) tools to track participant progress and support&#xD;
      patients and their providers in ongoing efforts to maintain weight loss. The investigators&#xD;
      used an EHR platform (Epic) employed by many health care systems nationwide and integrated&#xD;
      many parts of the MAINTAIN-pc protocol (e.g., patient identification, provider updates) with&#xD;
      routine clinic workflow.&#xD;
&#xD;
      Despite the success of MAINTAIN-pc, two key questions about the practicality and&#xD;
      sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted&#xD;
      at other sites and (ii) whether coaching could be delivered leveraging existing staff&#xD;
      resources rather than interventionists supported by a research grant. The investigators&#xD;
      propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc&#xD;
      protocol in routine health care settings: MAINTAIN PRIME (Promoting Real (World)&#xD;
      IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated&#xD;
      with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards&#xD;
      to track patient populations) and team-based care models to deliver the intervention with&#xD;
      minimal support from research staff. The investigators will measure costs to inform future&#xD;
      sustainability, and study workflow and individual, clinical, and organizational attributes to&#xD;
      determine facilitators and barriers to successful implementation. With assistance from an&#xD;
      External Advisory Board, the investigators will assemble an Implementation Toolkit of HIT and&#xD;
      clinical resources to aid further dissemination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 8, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</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>Pragmatic randomized clinical Trial with percent weight change at 24 months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in BMI percentage</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity as measured in daily steps</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity as measured in minutes</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dietary habits as measured by grams of fat</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dietary habits as measured in calories</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dietary habits as measured by validated diet habit survey score</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">269</enrollment>
  <condition>Diabetes</condition>
  <condition>Weight Loss</condition>
  <condition>Diet Habit</condition>
  <arm_group>
    <arm_group_label>Lifestyle coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control tracking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MAINTAIN PRIME Lifestyle Coaching</intervention_name>
    <description>Participants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback.</description>
    <arm_group_label>Lifestyle coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control tracking</intervention_name>
    <description>Participants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support.</description>
    <arm_group_label>Control tracking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-75&#xD;
&#xD;
          -  BMI of ≥ 25 prior to this intended weight loss&#xD;
&#xD;
          -  Have experienced and maintained an intentional weight loss of at least 5% of body&#xD;
             weight in the past 24 months&#xD;
&#xD;
          -  Plan to maintain a University of Utah Health relationship in one of the participating&#xD;
             primary care practices&#xD;
&#xD;
          -  Have or be willing to get an account with the Epic MyHealth patient portal embedded in&#xD;
             the electronic health record (EHR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical conditions that might cause unintended weight loss such as cancer or thyroid&#xD;
             disease&#xD;
&#xD;
          -  Provider's assessment that patient is unable to safely undertake moderately intense&#xD;
             unsupervised physical activity (the equivalent of 30 minutes of brisk walking)&#xD;
&#xD;
          -  Edematous state that interferes with bodyweight assessment (e.g., severe congestive&#xD;
             heart failure, end-stage renal disease, or ascites)&#xD;
&#xD;
          -  Bariatric surgery in the last 2 years, or planned during the next 3 years&#xD;
&#xD;
          -  Current or planned pregnancy in the next 3 years&#xD;
&#xD;
          -  Currently breastfeeding&#xD;
&#xD;
          -  Perceived lack of basic computer or Internet skills.&#xD;
&#xD;
          -  Unable to attend the orientation/baseline visit or comply with the protocol procedures&#xD;
&#xD;
          -  Any other underlying reason or concomitant condition, which in the opinion of the&#xD;
             principal investigator, could confound the results of the study or put the participant&#xD;
             at undue risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Utah Health Sciences Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Margaret (Molly) B. Conroy</investigator_full_name>
    <investigator_title>Professor, Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>weight loss</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Benzocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04420936
org study id: IRB_00132802
secondary id: 1R18DK123372-01A1
nct id: NCT04420936
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many people struggle not only to lose weight through changes in diet and physical activity,
      but also to maintain weight loss once they have achieved it. In a previous study, our team
      designed and deployed a weight maintenance intervention that was delivered through the
      patient portal of an electronic health record (EHR) and found that patients who tracked their
      weight, diet, and physical activity and also received coaching had better success with
      maintaining recent intentional weight loss than patients who tracked but did not receive
      coaching. The investigators propose to repeat the intervention in a new health care system
      and train routine health care staff (e.g., medical assistants and nurses) to be coaches, a
      more sustainable model that will allow ongoing intervention delivery after the proposed study
      ends.

      This is a pragmatic randomized clinical Trial with percent weight change at 24 months as the
      primary outcome. This will be a 2-arm randomized trial that compares the MAINTAIN PRIME
      lifestyle coaching intervention to a control tracking intervention.
Obesity is a major health problem in the United States and associated with increased risk of
      diabetes. While many behavioral interventions have led to successful short-term weight loss,
      very few programs focus on weight loss maintenance after intentional loss, and fewer still
      are applicable to routine health care settings. There is a great need for interventions that
      can assist with long-term maintenance of healthy body weight and be sustainably integrated
      into existing health care teams. The investigators have developed and tested an innovative
      weight loss maintenance intervention - Maintaining Activity and Nutrition through
      Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) - delivered through the
      electronic health record (EHR) to help patients maintain recent intentional weight loss and
      successful lifestyle strategies.

      The investigators have conducted and published a randomized clinical trial of MAINTAIN-pc at
      the University of Pittsburgh and found that participants who received EHR tracking tools and
      personalized coaching had significantly lower weight regain at 24 months (primary outcome)
      than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly
      available health information technology (HIT) tools to track participant progress and support
      patients and their providers in ongoing efforts to maintain weight loss. The investigators
      used an EHR platform (Epic) employed by many health care systems nationwide and integrated
      many parts of the MAINTAIN-pc protocol (e.g., patient identification, provider updates) with
      routine clinic workflow.

      Despite the success of MAINTAIN-pc, two key questions about the practicality and
      sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted
      at other sites and (ii) whether coaching could be delivered leveraging existing staff
      resources rather than interventionists supported by a research grant. The investigators
      propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc
      protocol in routine health care settings: MAINTAIN PRIME (Promoting Real (World)
      IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated
      with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards
      to track patient populations) and team-based care models to deliver the intervention with
      minimal support from research staff. The investigators will measure costs to inform future
      sustainability, and study workflow and individual, clinical, and organizational attributes to
      determine facilitators and barriers to successful implementation. With assistance from an
      External Advisory Board, the investigators will assemble an Implementation Toolkit of HIT and
      clinical resources to aid further dissemination.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pragmatic randomized clinical Trial with percent weight change at 24 months
primary purpose: Treatment
masking: None (Open Label)
measure: Change in body weight
time frame: 24 months
measure: Change in BMI percentage
time frame: 24 months
measure: Change in physical activity as measured in daily steps
time frame: 24 months
measure: Change in physical activity as measured in minutes
time frame: 24 months
measure: Change in dietary habits as measured by grams of fat
time frame: 24 months
measure: Change in dietary habits as measured in calories
time frame: 24 months
measure: Change in dietary habits as measured by validated diet habit survey score
time frame: 24 months
measure: Change in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores
time frame: 24 months
measure: Change in quality of function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores
time frame: 24 months
measure: Change in blood pressure
time frame: 24 months
arm group label: Lifestyle coaching
arm group type: Experimental
arm group label: Control tracking
arm group type: Active Comparator
intervention type: Behavioral
intervention name: MAINTAIN PRIME Lifestyle Coaching
description: Participants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback.
arm group label: Lifestyle coaching
intervention type: Behavioral
intervention name: Control tracking
description: Participants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support.
arm group label: Control tracking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Margaret (Molly) B. Conroy
investigator title: Professor, Internal Medicine
mesh term: Diabetes Mellitus
mesh term: Weight Loss
mesh term: Benzocaine
sharing ipd: No