<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/NCT03041831</url>
  </required_header>
  <id_info>
    <org_study_id>D16182_1a</org_study_id>
    <secondary_id>K23AG051681</secondary_id>
    <nct_id>NCT03041831</nct_id>
  </id_info>
  <brief_title>MOWI Qualitative Assessment</brief_title>
  <official_title>Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This qualitative study seeks to assess whether mobile health technologies are helpful for&#xD;
      older adults. It is the first in a series of four studies whose overarching goal is to&#xD;
      conduct a program of pilot research aimed at developing and evaluating a technology-assisted&#xD;
      wellness intervention for older adults with obesity who may or may not live in a rural area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed and conducted as a series of eighteen individual semi-structured&#xD;
      interviews and four focus group discussions. There are three participant groups: 1) older&#xD;
      adults (age ≥ 65 years) with diagnosed obesity, 2) primary care clinicians who care for older&#xD;
      adults, and 3) community leaders. Focus group discussions are conducted with the older adult&#xD;
      cohort only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2016</start_date>
  <completion_date type="Actual">April 28, 2020</completion_date>
  <primary_completion_date type="Actual">April 28, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Technology use in older adults</measure>
    <time_frame>Up to one year from interview or focus group</time_frame>
    <description>The investigators will record and transcribe each interview and focus group discussion for post-hoc evaluation. The investigators will then use the transcripts to identify themes on perceptions and experience with technology use in older adults.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determinants of obesity in older adults</measure>
    <time_frame>Up to one year from interview or focus group</time_frame>
    <description>The investigators will record and transcribe each interview and focus group discussion for post-hoc evaluation. The investigators will then use the transcripts to identify themes related to the secondary outcome. Themes may include (but are not limited to) barriers and facilitators experienced by older adults when they want to lose weight or eat healthier, barriers and facilitators to joining wellness programs, and general availability of options and support.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Older adult individual interviews</arm_group_label>
    <description>The investigators will conduct 8 semi-structured 60-minute interviews with patient participants.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinician individual interviews</arm_group_label>
    <description>The investigators will conduct 6 semi-structured 60-minute interviews with primary care clinicians who care for older adult populations.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community leader individual interviews</arm_group_label>
    <description>The investigators will conduct 4 semi-structured 60-minute interviews with community leaders.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Focus group discussions</arm_group_label>
    <description>The investigators will lead four 90-minute focus group discussions consisting of 6-8 older adult participants each. The goal of these focus groups is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Older adult participants screened and recruited primarily in local primary care setting&#xD;
        (Department of Community and Family Medicine at Dartmouth Hitchcock Medical Center), as&#xD;
        well as through other marketing channels such as posters and radio advertising. Community&#xD;
        leaders and clinicians recruited by invitation from the principal investigator.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥65 years;&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥ 30kg/m^2;&#xD;
&#xD;
          -  Waist circumference ≥88cm in females or ≥102cm in males&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe mental or life-threatening illness&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Substance use&#xD;
&#xD;
          -  History of bariatric surgery&#xD;
&#xD;
          -  Suicidal ideation&#xD;
&#xD;
          -  Unable to perform measures&#xD;
&#xD;
          -  Reside in a nursing home&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John A Batsis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center / Dartmouth Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT03085589?term=NCT03085589&amp;rank=1</url>
    <description>Mobile Health Obesity Wellness Intervention in Rural Older Adults: Amulet Technology Development &amp; Validation</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/show/NCT03104192</url>
    <description>Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/show/NCT03104205</url>
    <description>Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot</description>
  </link>
  <results_reference>
    <citation>Batsis JA, Dokko R, Naslund JA, Zagaria AB, Kotz D, Bartels SJ, Carpenter-Song E. Opportunities to Improve a Mobile Obesity Wellness Intervention for Rural Older Adults with Obesity. J Community Health. 2020 Feb;45(1):194-200. doi: 10.1007/s10900-019-00720-y.</citation>
    <PMID>31486958</PMID>
  </results_reference>
  <results_reference>
    <citation>Batsis JA, Zagaria AB, Halter RJ, Boateng GG, Proctor P, Bartels SJ, Kotz D. Use of Amulet in behavioral change for geriatric obesity management. Digit Health. 2019 Jun 21;5:2055207619858564. doi: 10.1177/2055207619858564. eCollection 2019 Jan-Dec.</citation>
    <PMID>31258927</PMID>
  </results_reference>
  <results_reference>
    <citation>Batsis JA, Zagaria A, Kotz DF, Bartels SJ, Boateng GG, Proctor PO, Halter RJ, Carpenter-Song EA. Usability Evaluation for the Amulet Wearable Device in Rural Older Adults with Obesity. Gerontechnology. 2018 Sep;17(3):151-159. doi: 10.4017/gt.2018.17.3.003.00.</citation>
    <PMID>30631251</PMID>
  </results_reference>
  <results_reference>
    <citation>Batsis JA, Naslund JA, Zagaria AB, Kotz D, Dokko R, Bartels SJ, Carpenter-Song E. Technology for Behavioral Change in Rural Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Apr-Jun;38(2):130-148. doi: 10.1080/21551197.2019.1600097. Epub 2019 Apr 11.</citation>
    <PMID>30971189</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>John A. Batsis, MD</investigator_full_name>
    <investigator_title>Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth</investigator_title>
  </responsible_party>
  <keyword>frail elderly</keyword>
  <keyword>telemedicine</keyword>
  <keyword>obesity</keyword>
  <keyword>rural health</keyword>
  <keyword>health promotion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03041831/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03041831
org study id: D16182_1a
secondary id: K23AG051681
nct id: NCT03041831
lead sponsor: 
collaborator: 
has dmc: No
This qualitative study seeks to assess whether mobile health technologies are helpful for
      older adults. It is the first in a series of four studies whose overarching goal is to
      conduct a program of pilot research aimed at developing and evaluating a technology-assisted
      wellness intervention for older adults with obesity who may or may not live in a rural area.
This study is designed and conducted as a series of eighteen individual semi-structured
      interviews and four focus group discussions. There are three participant groups: 1) older
      adults (age ≥ 65 years) with diagnosed obesity, 2) primary care clinicians who care for older
      adults, and 3) community leaders. Focus group discussions are conducted with the older adult
      cohort only.
observational model: Other
time perspective: Cross-Sectional
measure: Technology use in older adults
time frame: Up to one year from interview or focus group
description: The investigators will record and transcribe each interview and focus group discussion for post-hoc evaluation. The investigators will then use the transcripts to identify themes on perceptions and experience with technology use in older adults.
measure: Determinants of obesity in older adults
time frame: Up to one year from interview or focus group
description: The investigators will record and transcribe each interview and focus group discussion for post-hoc evaluation. The investigators will then use the transcripts to identify themes related to the secondary outcome. Themes may include (but are not limited to) barriers and facilitators experienced by older adults when they want to lose weight or eat healthier, barriers and facilitators to joining wellness programs, and general availability of options and support.
arm group label: Older adult individual interviews
description: The investigators will conduct 8 semi-structured 60-minute interviews with patient participants.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.
arm group label: Clinician individual interviews
description: The investigators will conduct 6 semi-structured 60-minute interviews with primary care clinicians who care for older adult populations.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.
arm group label: Community leader individual interviews
description: The investigators will conduct 4 semi-structured 60-minute interviews with community leaders.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.
arm group label: Focus group discussions
description: The investigators will lead four 90-minute focus group discussions consisting of 6-8 older adult participants each. The goal of these focus groups is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John A Batsis, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
facility: 
country: United States
url: https://clinicaltrials.gov/ct2/show/NCT03085589?term=NCT03085589&rank=1
description: Mobile Health Obesity Wellness Intervention in Rural Older Adults: Amulet Technology Development & Validation
url: https://clinicaltrials.gov/show/NCT03104192
description: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot
url: https://clinicaltrials.gov/show/NCT03104205
description: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot
citation: Batsis JA, Dokko R, Naslund JA, Zagaria AB, Kotz D, Bartels SJ, Carpenter-Song E. Opportunities to Improve a Mobile Obesity Wellness Intervention for Rural Older Adults with Obesity. J Community Health. 2020 Feb;45(1):194-200. doi: 10.1007/s10900-019-00720-y.
PMID: 31486958
citation: Batsis JA, Zagaria AB, Halter RJ, Boateng GG, Proctor P, Bartels SJ, Kotz D. Use of Amulet in behavioral change for geriatric obesity management. Digit Health. 2019 Jun 21;5:2055207619858564. doi: 10.1177/2055207619858564. eCollection 2019 Jan-Dec.
PMID: 31258927
citation: Batsis JA, Zagaria A, Kotz DF, Bartels SJ, Boateng GG, Proctor PO, Halter RJ, Carpenter-Song EA. Usability Evaluation for the Amulet Wearable Device in Rural Older Adults with Obesity. Gerontechnology. 2018 Sep;17(3):151-159. doi: 10.4017/gt.2018.17.3.003.00.
PMID: 30631251
citation: Batsis JA, Naslund JA, Zagaria AB, Kotz D, Dokko R, Bartels SJ, Carpenter-Song E. Technology for Behavioral Change in Rural Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Apr-Jun;38(2):130-148. doi: 10.1080/21551197.2019.1600097. Epub 2019 Apr 11.
PMID: 30971189
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: John A. Batsis, MD
investigator title: Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth
mesh term: Obesity
sharing ipd: No
provided document: 