<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/NCT03299348</url>
  </required_header>
  <id_info>
    <org_study_id>3437</org_study_id>
    <secondary_id>5R01AG051723-05</secondary_id>
    <nct_id>NCT03299348</nct_id>
  </id_info>
  <brief_title>AgingPLUS: Promoting Physical Activity in Adults</brief_title>
  <official_title>Testing Psychological Mechanisms to Promote Physical Activity in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Colorado State University</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>
      This study examines the efficacy of a psycho-educational intervention program, AgingPLUS,&#xD;
      with regard to increasing middle-aged and older adults' engagement in physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AgingPLUS is a multi-component intervention program that addresses negative views of aging&#xD;
      (NVOA), low internal control beliefs, and deficient goal planning as a risk cluster that&#xD;
      keeps adults from engaging in health-promoting behavior. The program focuses on engagement in&#xD;
      physical activity (PA) as the health behavior of choice. Engagement in PA is widely&#xD;
      recognized as the best non-pharmacological, non-invasive, and cost-effective method of health&#xD;
      promotion. Yet, only 20% of the adult population meets the recommended PA guidelines. This&#xD;
      suggests that messages about the benefits of PA alone are not effective. Rather, it is&#xD;
      essential to address the social-cognitive and motiva-tional mechanisms that prevent adults&#xD;
      from adopting and maintaining a regular PA regimen. NVOA, low internal control beliefs, and&#xD;
      deficient goal planning represent such a cluster of social-cognitive and motivational&#xD;
      mechanisms.&#xD;
&#xD;
      Given this background, the specific aims and hypotheses of the proposed research are:&#xD;
&#xD;
      Aim 1: To conduct a randomized controlled trial examining the efficacy of the AgingPLUS&#xD;
      program.&#xD;
&#xD;
      Aim 2: To test a conceptual model of the mechanisms underlying the intervention effects.&#xD;
&#xD;
      Aim 3: To conduct a 6-month follow-up to examine the longer-term effects of AgingPLUS.&#xD;
&#xD;
      Upon completion of this project, we expect to have successfully established evidence for the&#xD;
      efficacy of the AgingPLUS program (Stage II of the NIH Stage Mode). The long-term goal is to&#xD;
      develop AgingPLUS into a full-fledged evidence-based program that can be implemented in&#xD;
      community settings (e.g., senior centers), and can serve as a fairly brief and cost-effective&#xD;
      public health tool to promote healthy and successful aging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</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>The study has an active treatment group and an active control group</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Study participants, group leaders, and outcomes assessors will not know the study objectives or hypotheses.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Increased physical activity</measure>
    <time_frame>This effect should be observable (1) at the Week-4 post-test, (2) the Week-8 post-test, and (3) the 6-Month post-test.</time_frame>
    <description>We expect that participants significantly increase their engagement in physical activity as assessed by an accelerometer.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">335</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Active Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will get the AgingPLUS intervention program which addresses negative views on aging, low internal control beliefs, and deficient goal planning skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will get a generic health education program, called the &quot;10 Keys to Healthy Aging&quot;. The control program will control for the effect of social contact and will not address the intervention targets of the active treatment group. The health education program will only provide information related to some of the most important health conditions, such as cardiovascular disease, cancer, type 2 diabetes, and clinical depression, and how these conditions can be managed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AgingPLUS</intervention_name>
    <description>The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) how negative views on aging and negative age stereotypes undermine adults' health-promoting behaviors; (b) how adults can take control of their own aging; and (c) how personal goals can be achieved through more effective goal planning and action plans.</description>
    <arm_group_label>Active Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Control Group</intervention_name>
    <description>The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) four major health conditions that affect the lives of many middle-aged and older adults (e.g., cardiovascular disease, cancer, type 2 diabetes; clinical depression); and (b) how these conditions can be managed successfully.</description>
    <arm_group_label>Active Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults who engage in less than 60 minutes of PA per week and who intend starting a&#xD;
             physical exercise program.&#xD;
&#xD;
          -  English speaking.&#xD;
&#xD;
          -  Willingness to be randomized to one of two programs.&#xD;
&#xD;
          -  Willingness to take part in the physical fitness tests and wear an accelerometer.&#xD;
&#xD;
          -  Willingness to commit to follow-up testing (i.e., not moving out of the area during&#xD;
             the study period).&#xD;
&#xD;
          -  Physician clearance to take part in a submaximal exercise test and to begin an&#xD;
             exercise program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs of cognitive decline (defined as more than 4 errors on the Short Portable Mental&#xD;
             Status Questionnaire).&#xD;
&#xD;
          -  Severe vision and/or hearing loss (obtained by self-report).&#xD;
&#xD;
          -  Serious problems with mobility.&#xD;
&#xD;
          -  A history of neurological, mental, or substance abuse disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants will self-identify their gender orientation.</gender_description>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manfred K. Diehl, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado State University</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80523-1570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1123/japa.2016-0039</url>
    <description>Digital Object Identifier to the citation</description>
  </link>
  <reference>
    <citation>Brothers A, Diehl M. Feasibility and Efficacy of the AgingPlus Program: Changing Views on Aging to Increase Physical Activity. J Aging Phys Act. 2017 Jul;25(3):402-411. doi: 10.1123/japa.2016-0039. Epub 2016 Dec 5.</citation>
    <PMID>27918687</PMID>
  </reference>
  <reference>
    <citation>Diehl M, Nehrkorn-Bailey A, Thompson K, Rodriguez D, Li K, Rebok GW, Roth DL, Chung SE, Bland C, Feltner S, Forsyth G, Hulett N, Klein B, Mars P, Martinez K, Mast S, Monasterio R, Moore K, Schoenberg H, Thomson E, Tseng HY. The AgingPLUS trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults. Contemp Clin Trials. 2020 Sep;96:106105. doi: 10.1016/j.cct.2020.106105. Epub 2020 Aug 11.</citation>
    <PMID>32791322</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Colorado State University</investigator_affiliation>
    <investigator_full_name>Manfred Diehl, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Psychological Mechanisms</keyword>
  <keyword>Social-Cognitive Mechanisms</keyword>
  <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>September 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03299348/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/NCT03299348
org study id: 3437
secondary id: 5R01AG051723-05
nct id: NCT03299348
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study examines the efficacy of a psycho-educational intervention program, AgingPLUS,
      with regard to increasing middle-aged and older adults' engagement in physical activity.
AgingPLUS is a multi-component intervention program that addresses negative views of aging
      (NVOA), low internal control beliefs, and deficient goal planning as a risk cluster that
      keeps adults from engaging in health-promoting behavior. The program focuses on engagement in
      physical activity (PA) as the health behavior of choice. Engagement in PA is widely
      recognized as the best non-pharmacological, non-invasive, and cost-effective method of health
      promotion. Yet, only 20% of the adult population meets the recommended PA guidelines. This
      suggests that messages about the benefits of PA alone are not effective. Rather, it is
      essential to address the social-cognitive and motiva-tional mechanisms that prevent adults
      from adopting and maintaining a regular PA regimen. NVOA, low internal control beliefs, and
      deficient goal planning represent such a cluster of social-cognitive and motivational
      mechanisms.

      Given this background, the specific aims and hypotheses of the proposed research are:

      Aim 1: To conduct a randomized controlled trial examining the efficacy of the AgingPLUS
      program.

      Aim 2: To test a conceptual model of the mechanisms underlying the intervention effects.

      Aim 3: To conduct a 6-month follow-up to examine the longer-term effects of AgingPLUS.

      Upon completion of this project, we expect to have successfully established evidence for the
      efficacy of the AgingPLUS program (Stage II of the NIH Stage Mode). The long-term goal is to
      develop AgingPLUS into a full-fledged evidence-based program that can be implemented in
      community settings (e.g., senior centers), and can serve as a fairly brief and cost-effective
      public health tool to promote healthy and successful aging.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study has an active treatment group and an active control group
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Study participants, group leaders, and outcomes assessors will not know the study objectives or hypotheses.
measure: Increased physical activity
time frame: This effect should be observable (1) at the Week-4 post-test, (2) the Week-8 post-test, and (3) the 6-Month post-test.
description: We expect that participants significantly increase their engagement in physical activity as assessed by an accelerometer.
arm group label: Active Treatment Group
arm group type: Experimental
description: This group will get the AgingPLUS intervention program which addresses negative views on aging, low internal control beliefs, and deficient goal planning skills.
arm group label: Active Control Group
arm group type: Placebo Comparator
description: This group will get a generic health education program, called the "10 Keys to Healthy Aging". The control program will control for the effect of social contact and will not address the intervention targets of the active treatment group. The health education program will only provide information related to some of the most important health conditions, such as cardiovascular disease, cancer, type 2 diabetes, and clinical depression, and how these conditions can be managed.
intervention type: Behavioral
intervention name: AgingPLUS
description: The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) how negative views on aging and negative age stereotypes undermine adults' health-promoting behaviors; (b) how adults can take control of their own aging; and (c) how personal goals can be achieved through more effective goal planning and action plans.
arm group label: Active Treatment Group
intervention type: Behavioral
intervention name: Active Control Group
description: The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) four major health conditions that affect the lives of many middle-aged and older adults (e.g., cardiovascular disease, cancer, type 2 diabetes; clinical depression); and (b) how these conditions can be managed successfully.
arm group label: Active Control Group
criteria: 
gender: All
gender based: Yes
gender description: Participants will self-identify their gender orientation.
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Manfred K. Diehl, PhD
role: Principal Investigator
affiliation: Colorado State University
facility: 
country: United States
url: https://doi.org/10.1123/japa.2016-0039
description: Digital Object Identifier to the citation
citation: Brothers A, Diehl M. Feasibility and Efficacy of the AgingPlus Program: Changing Views on Aging to Increase Physical Activity. J Aging Phys Act. 2017 Jul;25(3):402-411. doi: 10.1123/japa.2016-0039. Epub 2016 Dec 5.
PMID: 27918687
citation: Diehl M, Nehrkorn-Bailey A, Thompson K, Rodriguez D, Li K, Rebok GW, Roth DL, Chung SE, Bland C, Feltner S, Forsyth G, Hulett N, Klein B, Mars P, Martinez K, Mast S, Monasterio R, Moore K, Schoenberg H, Thomson E, Tseng HY. The AgingPLUS trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults. Contemp Clin Trials. 2020 Sep;96:106105. doi: 10.1016/j.cct.2020.106105. Epub 2020 Aug 11.
PMID: 32791322
responsible party type: Principal Investigator
investigator affiliation: Colorado State University
investigator full name: Manfred Diehl, PhD
investigator title: Professor
sharing ipd: No
provided document: 