<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/NCT04490356</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00105630</org_study_id>
    <secondary_id>1P30AG064201-01</secondary_id>
    <nct_id>NCT04490356</nct_id>
  </id_info>
  <brief_title>Enhancing Physical Function in the Long-term for Older Adults</brief_title>
  <official_title>Extending Legacy Benefits of Obesity Reduction in Older Adults: A Novel Telehealth Intervention Using Nutrition and Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intervention being studied is a 12-week nutrition and physical activity intervention,&#xD;
      delivered using videoconference technology by registered dietitian clinicians to maintain&#xD;
      weight loss and functional gains in older adults who successfully completed a weight loss&#xD;
      intervention. The &quot;Legacy Intervention&quot; will include cognitive behavioral strategies (e.g.,&#xD;
      goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches,&#xD;
      including daily and weekly text reminders, virtual exercise classes, virtual individual and&#xD;
      group nutrition classes, and step tracking device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Awaiting additional funding to enroll additional participants&#xD;
  </why_stopped>
  <start_date type="Actual">April 26, 2021</start_date>
  <completion_date type="Anticipated">November 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>12 week endpoint</time_frame>
    <description>Completion of at least 85% of tele-nutrition and tele-exercise intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability as measured by Participant Satisfaction</measure>
    <time_frame>12 week endpoint</time_frame>
    <description>Participants will asked to rate their satisfaction using a five point likert scale (very dissatisfied; dissatisfied; neutral; satisfied; very satisfied) on a) satisfaction with the delivery of the tele-nutrition intervention, b) satisfaction with the delivery of the tele-exercise intervention c) satisfaction with their ability to maintain their physical function d) satisfaction with their ability to maintain their weight loss e) satisfaction with interactions with the registered dietitian.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in physical performance as measured by the Short Physical Performance Battery</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score of Short Physical Performance Battery score from baseline, 6 and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical function as measured using the 6 minute walk test</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for distance walked in six minutes from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight as measured by the Aria Fitbit Scale</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for body weight from baseline, 6 and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body mass as measured by the Aria Fitbit Scale (%)</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for percent body mass from baseline, 6 and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in average weekly steps measured using Garmin watch</measure>
    <time_frame>Every week for 12 weeks</time_frame>
    <description>Using Garmin watch to determine average weekly step count over 12 weeks study and compare change in weekly step count over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total calories using 3-day food record (participants record everything they eat and drink for three days</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for total calories will be measured using 3-day food records from baseline, 6 and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in macronutrients using 3-day food record (participants record everything they eat and drink for three days</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Macronutrient intake will be measured using 3-day food records from baseline, 6 and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stress using the Perceived Stress Scale</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for stress from baseline, 6 and 12 weeks. Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-reported Depression using the Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for self-reported depression from baseline, 6 and 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mood using the Profile of Mood States questionnaire</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from &quot;not at all&quot; to &quot;extremely&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life using the SF-36 questionnaire</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Change score for the Physical and Mental composite scores from baseline 0, 6, and 12 weeks.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Weight Loss Maintenance</condition>
  <arm_group>
    <arm_group_label>Legacy Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Legacy Intervention</intervention_name>
    <description>The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.</description>
    <arm_group_label>Legacy Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body&#xD;
             weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters&#xD;
&#xD;
          -  Age ≥ 60&#xD;
&#xD;
          -  Able to speak and understand spoken and written English.&#xD;
&#xD;
          -  Able to record dietary intake and weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of unstable or symptomatic life-threatening illness&#xD;
&#xD;
          -  Neurological conditions causing functional impairment, including Parkinson's disease,&#xD;
             multiple sclerosis, and permanent disability due to stroke&#xD;
&#xD;
          -  Inability to complete physical function assessment&#xD;
&#xD;
          -  No access to internet connection to participate in the tele-intervention&#xD;
&#xD;
          -  Unable or unwilling to use provided tablet to participant in tele-intervention&#xD;
&#xD;
          -  History of cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Starr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University, School of Medicine</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 25, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT04490356/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/NCT04490356
org study id: PRO00105630
secondary id: 1P30AG064201-01
nct id: NCT04490356
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The intervention being studied is a 12-week nutrition and physical activity intervention,
      delivered using videoconference technology by registered dietitian clinicians to maintain
      weight loss and functional gains in older adults who successfully completed a weight loss
      intervention. The "Legacy Intervention" will include cognitive behavioral strategies (e.g.,
      goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches,
      including daily and weekly text reminders, virtual exercise classes, virtual individual and
      group nutrition classes, and step tracking device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Retention
time frame: 12 week endpoint
description: Completion of at least 85% of tele-nutrition and tele-exercise intervention
measure: Acceptability as measured by Participant Satisfaction
time frame: 12 week endpoint
description: Participants will asked to rate their satisfaction using a five point likert scale (very dissatisfied; dissatisfied; neutral; satisfied; very satisfied) on a) satisfaction with the delivery of the tele-nutrition intervention, b) satisfaction with the delivery of the tele-exercise intervention c) satisfaction with their ability to maintain their physical function d) satisfaction with their ability to maintain their weight loss e) satisfaction with interactions with the registered dietitian.
measure: Change in physical performance as measured by the Short Physical Performance Battery
time frame: 0, 6, 12 weeks
description: Change score of Short Physical Performance Battery score from baseline, 6 and 12 weeks
measure: Change in physical function as measured using the 6 minute walk test
time frame: 0, 6, 12 weeks
description: Change score for distance walked in six minutes from baseline
measure: Change in body weight as measured by the Aria Fitbit Scale
time frame: 0, 6, 12 weeks
description: Change score for body weight from baseline, 6 and 12 weeks
measure: Change in Body mass as measured by the Aria Fitbit Scale (%)
time frame: 0, 6, 12 weeks
description: Change score for percent body mass from baseline, 6 and 12 weeks
measure: Change in average weekly steps measured using Garmin watch
time frame: Every week for 12 weeks
description: Using Garmin watch to determine average weekly step count over 12 weeks study and compare change in weekly step count over time.
measure: Change in total calories using 3-day food record (participants record everything they eat and drink for three days
time frame: 0, 6, 12 weeks
description: Change score for total calories will be measured using 3-day food records from baseline, 6 and 12 weeks
measure: Change in macronutrients using 3-day food record (participants record everything they eat and drink for three days
time frame: 0, 6, 12 weeks
description: Macronutrient intake will be measured using 3-day food records from baseline, 6 and 12 weeks
measure: Change in Stress using the Perceived Stress Scale
time frame: 0, 6, 12 weeks
description: Change score for stress from baseline, 6 and 12 weeks. Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
measure: Change in Self-reported Depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: 0, 6, 12 weeks
description: Change score for self-reported depression from baseline, 6 and 12 weeks.
measure: Change in Mood using the Profile of Mood States questionnaire
time frame: 0, 6, 12 weeks
description: Change score for mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".
measure: Change in quality of life using the SF-36 questionnaire
time frame: 0, 6, 12 weeks
description: Change score for the Physical and Mental composite scores from baseline 0, 6, and 12 weeks.
arm group label: Legacy Intervention
arm group type: Experimental
description: Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
intervention type: Behavioral
intervention name: Legacy Intervention
description: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
arm group label: Legacy Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathryn Starr, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No
provided document: 