<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/NCT03826173</url>
  </required_header>
  <id_info>
    <org_study_id>1R21CA224609-01A1</org_study_id>
    <secondary_id>1R21CA224609-01A1</secondary_id>
    <nct_id>NCT03826173</nct_id>
  </id_info>
  <brief_title>Positive Psychology for Physical Activity Promotion</brief_title>
  <acronym>PPPA</acronym>
  <official_title>Physical Activity Promotion Based on Positive Psychology: Development and Piloting of a Novel Intervention Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</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>
      This study is for physically inactive adults. Participants will be enrolled in the Positive&#xD;
      Psychology and Physical Activity intervention designed to help them overcome barriers to&#xD;
      physical activity, based on the principals of positive psychology.&#xD;
&#xD;
      This will involve six weekly one-hour group-based sessions at a local YMCA with a trained&#xD;
      group leader. In addition to the in-person sessions, there will be text messages sent to&#xD;
      participants about physical activity that include positive psychology content.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to conduct a pilot study to test feasibility and proof-of-concept&#xD;
      for a positive psychology intervention program to promote exercise among low-active&#xD;
      overweight and obese adults. The program will be (a) a 6-week, group-based intervention, (b)&#xD;
      delivered at local YMCAs, and (c) supplemented with text messaging. In an additive design,&#xD;
      participants will be randomized in a 2:1 ratio to PPPA (n = 40) versus a control intervention&#xD;
      (n = 20) including only the standard PA promotion components of the PPPA intervention (i.e.,&#xD;
      PA education, self-monitoring, and goal-setting), with equal frequency of staff contact and&#xD;
      text message delivery. All participants will be followed for 3 months, and will receive a&#xD;
      3-month YMCA membership to equate access to PA facilities. As a secondary aim the&#xD;
      investigators will examine effect sizes for PPPA versus the standard PA intervention on&#xD;
      putative mediators that may underlie the efficacy of PPPA in improving PA outcomes, including&#xD;
      positive and negative affect, optimism, happiness, life satisfaction, social support for PA,&#xD;
      and PA enjoyment. The proposed research will set the stage for an RCT to test a novel PA&#xD;
      promotion intervention that can be readily disseminated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2018</start_date>
  <completion_date type="Actual">July 8, 2020</completion_date>
  <primary_completion_date type="Actual">July 8, 2020</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week</measure>
    <time_frame>Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).</time_frame>
    <description>Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week [Time Frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Positive and Negative Affect</measure>
    <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
    <description>The Positive and Negative Affect Scale measures changes in positive and negative affect. Both positive and negative affect sub-scales will be scored (scores range from 10 to 50 for each individual sub-scale), with higher scores on the positive affect scale and lower scores on the negative affect scale indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Optimism</measure>
    <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
    <description>Life Orientation Test- Revised measures trait optimism. Scores range from 10 to 50, with higher scores reflecting greater optimism. Higher scores will reflect better outcomes of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Happiness</measure>
    <time_frame>Survey will be administered at baseline, week 4, week 7, and week 10.</time_frame>
    <description>Measure of subjective happiness. Scores range from 4 to 28, with higher scores reflecting greater subjective happiness. Higher scores will reflect better outcomes of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction With Life</measure>
    <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
    <description>Measures subjective well-being. Scores range from 5 to 35, with higher scores reflecting greater satisfaction with life and subjective well-being. Higher scores will reflect better outcomes of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social Support for Exercise</measure>
    <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
    <description>Measures perceived social support for regular exercise. Scores range from 13 to 65, with higher scores reflecting greater social support. Will be assessed as a putative mediator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity Enjoyment</measure>
    <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
    <description>Measures enjoyment of physical activity. Scores range from 18 to 126, with higher scores reflecting greater enjoyment. Will be assessed as a putative mediator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Obesity</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Positive Psychology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Activity Promotion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on the standard physical activity promotion components of the PPPA condition. Participants will receive daily text-messages addressing the content introduced during group sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PPPA</intervention_name>
    <description>The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
    <arm_group_label>Positive Psychology</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PA</intervention_name>
    <description>The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.</description>
    <arm_group_label>Physical Activity Promotion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary or low-active, (defined as &lt; 60 min/week of structured physical activity)&#xD;
&#xD;
          -  Able to receive and respond to a text message at the time of screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of coronary artery disease&#xD;
&#xD;
          -  History of stroke&#xD;
&#xD;
          -  History of uncontrolled hypertension&#xD;
&#xD;
          -  History of asthma&#xD;
&#xD;
          -  History of chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  History of diabetes&#xD;
&#xD;
          -  History of osteoarthritis or orthopedic problems that limit physical activity&#xD;
&#xD;
          -  BMI greater than 40&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M Williams, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brown University School of Public Health</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>January 12, 2023</results_first_submitted>
  <results_first_submitted_qc>March 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2023</results_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Positive Psychology</keyword>
  <keyword>Affect</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.</ipd_description>
    <ipd_time_frame>Data will be made available 1 year after the completion of the study.</ipd_time_frame>
    <ipd_access_criteria>All data access requests will be reviewed by a panel prior to acceptance.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03826173/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <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>March 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03826173/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Positive Psychology Phase 1</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
        </group>
        <group group_id="P2">
          <title>Positive Psychology Phase 2</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
        </group>
        <group group_id="P3">
          <title>Physical Activity Promotion</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on the standard physical activity promotion components of the PPPA condition. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PA: The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="6">Treatment was cut short by COVID-19</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Positive Psychology Phase 1</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
        </group>
        <group group_id="B2">
          <title>Positive Psychology Phase 2</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
        </group>
        <group group_id="B3">
          <title>Physical Activity Promotion</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on the standard physical activity promotion components of the PPPA condition. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PA: The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.9" spread="12.8"/>
                    <measurement group_id="B2" value="40.1" spread="14.5"/>
                    <measurement group_id="B3" value="37.3" spread="15.2"/>
                    <measurement group_id="B4" value="40.9" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>Gender: 1=male, 2=female, 3=non-binary/third gender, 4=prefer to self-describe, 5=prefer not to say</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer not to say</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week</title>
        <description>Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week [Time Frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).]</description>
        <time_frame>Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).</time_frame>
        <population>Reporting of raw means. This is a feasibility study. It lacks adequate power for inferential analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychology Phase 1</title>
            <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
          </group>
          <group group_id="O2">
            <title>Positive Psychology Phase 2</title>
            <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
          </group>
          <group group_id="O3">
            <title>Physical Activity Promotion</title>
            <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on the standard physical activity promotion components of the PPPA condition. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PA: The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week</title>
          <description>Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week [Time Frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).]</description>
          <population>Reporting of raw means. This is a feasibility study. It lacks adequate power for inferential analysis.</population>
          <units>Minutes of physical activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.4" spread="51.8"/>
                    <measurement group_id="O2" value="83.0" spread="105.1"/>
                    <measurement group_id="O3" value="88.4" spread="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5" spread="50.2"/>
                    <measurement group_id="O2" value="95.1" spread="84.6"/>
                    <measurement group_id="O3" value="140.7" spread="97.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" spread="29.7"/>
                    <measurement group_id="O2" value="125.4" spread="107.2"/>
                    <measurement group_id="O3" value="61.0" spread="61.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Positive and Negative Affect</title>
        <description>The Positive and Negative Affect Scale measures changes in positive and negative affect. Both positive and negative affect sub-scales will be scored (scores range from 10 to 50 for each individual sub-scale), with higher scores on the positive affect scale and lower scores on the negative affect scale indicating a better outcome.</description>
        <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Optimism</title>
        <description>Life Orientation Test- Revised measures trait optimism. Scores range from 10 to 50, with higher scores reflecting greater optimism. Higher scores will reflect better outcomes of the intervention.</description>
        <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Subjective Happiness</title>
        <description>Measure of subjective happiness. Scores range from 4 to 28, with higher scores reflecting greater subjective happiness. Higher scores will reflect better outcomes of the intervention.</description>
        <time_frame>Survey will be administered at baseline, week 4, week 7, and week 10.</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Satisfaction With Life</title>
        <description>Measures subjective well-being. Scores range from 5 to 35, with higher scores reflecting greater satisfaction with life and subjective well-being. Higher scores will reflect better outcomes of the intervention.</description>
        <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Social Support for Exercise</title>
        <description>Measures perceived social support for regular exercise. Scores range from 13 to 65, with higher scores reflecting greater social support. Will be assessed as a putative mediator.</description>
        <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Physical Activity Enjoyment</title>
        <description>Measures enjoyment of physical activity. Scores range from 18 to 126, with higher scores reflecting greater enjoyment. Will be assessed as a putative mediator.</description>
        <time_frame>Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Six weeks per participant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Positive Psychology Phase 1</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
        </group>
        <group group_id="E2">
          <title>Positive Psychology Phase 2</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.</description>
        </group>
        <group group_id="E3">
          <title>Physical Activity Promotion</title>
          <description>On a weekly basis, participants will engage in group-based intervention sessions that focus on the standard physical activity promotion components of the PPPA condition. Participants will receive daily text-messages addressing the content introduced during group sessions.&#xD;
PA: The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David M Williams</name_or_title>
      <organization>Brown University School of Public Health</organization>
      <phone>4018636248</phone>
      <email>david_m_williams@brown.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03826173
org study id: 1R21CA224609-01A1
secondary id: 1R21CA224609-01A1
nct id: NCT03826173
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is for physically inactive adults. Participants will be enrolled in the Positive
      Psychology and Physical Activity intervention designed to help them overcome barriers to
      physical activity, based on the principals of positive psychology.

      This will involve six weekly one-hour group-based sessions at a local YMCA with a trained
      group leader. In addition to the in-person sessions, there will be text messages sent to
      participants about physical activity that include positive psychology content.
The investigators propose to conduct a pilot study to test feasibility and proof-of-concept
      for a positive psychology intervention program to promote exercise among low-active
      overweight and obese adults. The program will be (a) a 6-week, group-based intervention, (b)
      delivered at local YMCAs, and (c) supplemented with text messaging. In an additive design,
      participants will be randomized in a 2:1 ratio to PPPA (n = 40) versus a control intervention
      (n = 20) including only the standard PA promotion components of the PPPA intervention (i.e.,
      PA education, self-monitoring, and goal-setting), with equal frequency of staff contact and
      text message delivery. All participants will be followed for 3 months, and will receive a
      3-month YMCA membership to equate access to PA facilities. As a secondary aim the
      investigators will examine effect sizes for PPPA versus the standard PA intervention on
      putative mediators that may underlie the efficacy of PPPA in improving PA outcomes, including
      positive and negative affect, optimism, happiness, life satisfaction, social support for PA,
      and PA enjoyment. The proposed research will set the stage for an RCT to test a novel PA
      promotion intervention that can be readily disseminated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week
time frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).
description: Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week [Time Frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).]
measure: Change in Positive and Negative Affect
time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
description: The Positive and Negative Affect Scale measures changes in positive and negative affect. Both positive and negative affect sub-scales will be scored (scores range from 10 to 50 for each individual sub-scale), with higher scores on the positive affect scale and lower scores on the negative affect scale indicating a better outcome.
measure: Change in Optimism
time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
description: Life Orientation Test- Revised measures trait optimism. Scores range from 10 to 50, with higher scores reflecting greater optimism. Higher scores will reflect better outcomes of the intervention.
measure: Change in Subjective Happiness
time frame: Survey will be administered at baseline, week 4, week 7, and week 10.
description: Measure of subjective happiness. Scores range from 4 to 28, with higher scores reflecting greater subjective happiness. Higher scores will reflect better outcomes of the intervention.
measure: Change in Satisfaction With Life
time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
description: Measures subjective well-being. Scores range from 5 to 35, with higher scores reflecting greater satisfaction with life and subjective well-being. Higher scores will reflect better outcomes of the intervention.
measure: Change in Social Support for Exercise
time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
description: Measures perceived social support for regular exercise. Scores range from 13 to 65, with higher scores reflecting greater social support. Will be assessed as a putative mediator.
measure: Change in Physical Activity Enjoyment
time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
description: Measures enjoyment of physical activity. Scores range from 18 to 126, with higher scores reflecting greater enjoyment. Will be assessed as a putative mediator.
arm group label: Positive Psychology
arm group type: Experimental
description: On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.
arm group label: Physical Activity Promotion
arm group type: Active Comparator
description: On a weekly basis, participants will engage in group-based intervention sessions that focus on the standard physical activity promotion components of the PPPA condition. Participants will receive daily text-messages addressing the content introduced during group sessions.
intervention type: Behavioral
intervention name: PPPA
description: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.
arm group label: Positive Psychology
intervention type: Behavioral
intervention name: PA
description: The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.
arm group label: Physical Activity Promotion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David M Williams, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.
ipd time frame: Data will be made available 1 year after the completion of the study.
ipd access criteria: All data access requests will be reviewed by a panel prior to acceptance.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 