<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/NCT04404478</url>
  </required_header>
  <id_info>
    <org_study_id>B-SWELL2019</org_study_id>
    <secondary_id>K01HL141676</secondary_id>
    <nct_id>NCT04404478</nct_id>
  </id_info>
  <brief_title>Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)</brief_title>
  <acronym>B-SWELL</acronym>
  <official_title>Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</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 research study examines the unique cultural and gender-based factors that influence how&#xD;
      midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily&#xD;
      life. The B-SWELL intervention uses stress reduction and goal setting to increase self&#xD;
      efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared&#xD;
      to an inattention control wellness group in a randomized control trial. The long-term outcome&#xD;
      is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease (CVD) is the primary cause of death in all women, and as women&#xD;
      transition through midlife, the prevalence of CVD exceeds that of men.1 Midlife Black women,&#xD;
      defined as ages 40-64,unduly shoulder the burden of CVD (49%), hypertension (40%), and heart&#xD;
      failure (50% greater risk). Midlife Black women also report higher levels of chronic stress&#xD;
      and greater numbers of stressful life events in comparison to midlife White women, putting&#xD;
      them at greater risk for CVD. In addition to the physical impact, coping with chronic stress&#xD;
      takes time and energy away from self-care, functioning as a barrier to the adoption of&#xD;
      healthy lifestyle behaviors. Existent interventions do not fully address the unique factors&#xD;
      contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black&#xD;
      women.&#xD;
&#xD;
      The purpose of this research proposal is to develop a midlife Black women's Stress-reduction&#xD;
      WELLness intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors&#xD;
      and themes identified in preliminary research. Community-based participatory research (CBPR)&#xD;
      methods will be used to engage the community and include midlife Black women in the&#xD;
      development of the B-SWELL. We propose that the skills and knowledge gained through&#xD;
      participation in the B-SWELL program will increase receptivity to the healthy lifestyle&#xD;
      behaviors outlined in the American Heart Association's Life Simple 7 Success Plan (LS7). The&#xD;
      LS7 targets seven risk factors known to increase cardiovascular related health risk:&#xD;
      cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and&#xD;
      smoking.&#xD;
&#xD;
      Our hypothesis proposes that low stress scores and greater self efficacy will be associated&#xD;
      with the adoption of AHA's healthy lifestyle behaviors. Low stress and self efficacy will be&#xD;
      facilitated through peer support and culturally relevant content, materials, and themes.&#xD;
      B-SWELL participants will show improved self-efficacy in managing life stress and adopting&#xD;
      the LS7 behaviors, compared to a control group receiving traditional wellness education (WE&#xD;
      group).&#xD;
&#xD;
      Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative&#xD;
      leveraging of CBPR methodology and LS7 modifiable healthy lifestyle behaviors.&#xD;
&#xD;
        1. To develop components of the B-SWELL intervention prototype for midlife Black women.&#xD;
&#xD;
        2. Obtain ratings of the new components of the B-SWELL from our community advisory board&#xD;
           for degree of accuracy, relevance, and feasibility to inform further refinements.&#xD;
&#xD;
      Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black&#xD;
      women randomized to the B-SWELL intervention (25) or to a wellness education (WE) control&#xD;
      group (25):&#xD;
&#xD;
        1. Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for&#xD;
           the intervention procedures for both groups;&#xD;
&#xD;
        2. Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL&#xD;
           intervention group with those in the WE group at 8 and 12 weeks.&#xD;
&#xD;
        3. Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive&#xD;
           symptoms) for participants in the B-SWELL intervention group with those in the WE&#xD;
           attention control group at 8 and 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2021</start_date>
  <completion_date type="Actual">June 12, 2021</completion_date>
  <primary_completion_date type="Actual">June 12, 2021</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>Randomized control trial comparing intervention group (B-SWELL) with an attention control group (WE) to assess the following outcomes: healthy lifestyle scores, perceived stress scores, self efficacy, unhealthy days, and depressive symptoms.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The participants will be randomized into groups. Group sessions held online on different dates and times. Participants are asked not to share details about the study. Data collectors are blinded to participant grouping. Facilitators are blinded to the groups they are not facilitating.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>American Heart Association's Life's Simple Seven (LS7) Score</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unhealthy Days</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>'Unhealthy Days' is measures by the number of unhealthy days reported by the participant. This question asks the participant how many days in past month that their physical/mental health was not good. This is a continuous numeric response. Higher numbers indicate poorer health during the reported timeframe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived General Health</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>The Perceived General Health question is one item from the Short Form Health Survey. The participants will rate their health as 'excellent', 'very good', 'good', 'fair' and 'poor'. Responses are categorical. The reported outcome reflects the number of participants who rate their health as 'good'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ9)</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>The PHQ9 measures depressive symptoms. Participants rate their depressive symptoms from '0' (not at all) to '3' (every day). Scores range from 0 to 27. Higher scores indicate greater risk of clinical depression. Lower scores indicate less risk for depression.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cohen's Perceived Stress Scale (PSS-10)</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>The Perceived stress scale (PSS-10) measures a person's perception of general stress. Items are rated on a scale of 0 to 4 with a maximum score of 40. Higher levels of stress correspond with higher scores. Low scores indicate less stress.</description>
  </other_outcome>
  <other_outcome>
    <measure>General Self-Efficacy Scale (GSE)</measure>
    <time_frame>baseline to 12 weeks.</time_frame>
    <description>The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with life demands. The total score is calculated by finding the sum of the all items. Scores range from 1 (not at all true) to 4 (exactly true). Total scores range between 10 and 40. A higher score indicates greater self-efficacy in achieving a particular outcome. Lower scores indicate the participant has less self-efficacy in achieving the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction (Adapted From Satisfaction Questionnaire).</measure>
    <time_frame>8 weeks</time_frame>
    <description>Satisfaction. Participants rate their satisfaction of the overall B-SWELL program using a Likert type scale ranging from 1=strongly disagree to 5=strongly agree. The questionnaire includes items for usefulness, ease of use, and acceptability of the intervention. Ratings are averaged across participants.&#xD;
The results reported here refer to the question: 'The weekly program materials addressed the problems I was having as a midlife Black woman.'</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Stress</condition>
  <condition>Self Efficacy</condition>
  <condition>Depressive Symptoms</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>B-SWELL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>B-SWELL: Midlife Black Women's Stress Reduction Wellness Program</intervention_name>
    <description>Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.</description>
    <arm_group_label>B-SWELL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WE: Wellness program for Midlife Black Women</intervention_name>
    <description>Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.</description>
    <arm_group_label>WE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fluent in the English language,&#xD;
&#xD;
          -  ability to hear and talk well enough to engage in everyday conversation,&#xD;
&#xD;
          -  access to a telephone with messaging,&#xD;
&#xD;
          -  access to WIFI,&#xD;
&#xD;
          -  willingness to participate for duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent immigration to the U.S.,&#xD;
&#xD;
          -  prisoner or on house arrest,&#xD;
&#xD;
          -  pregnant,&#xD;
&#xD;
          -  terminal illness (i.e., late stage cancer, end-of-life condition, renal failure&#xD;
             requiring dialysis),&#xD;
&#xD;
          -  history of Alzheimer's, dementia, or severe mental illness (i.e., suicidal tendencies,&#xD;
             schizophrenia, or severe untreated depression),&#xD;
&#xD;
          -  any other major health conditions or disabilities prohibiting safe participation in&#xD;
             the program.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Midlife Black/African-American women between the ages of 40 and 64,</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Holly J Jones, PhD,RN,NP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cincinnati, College of Nursing</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jones HJ, Norwood CR, Bankston K. Leveraging Community Engagement to Develop Culturally Tailored Stress Management Interventions in Midlife Black Women. J Psychosoc Nurs Ment Health Serv. 2019 Mar 1;57(3):32-38. doi: 10.3928/02793695-20180925-01. Epub 2018 Oct 1.</citation>
    <PMID>30272812</PMID>
  </reference>
  <reference>
    <citation>Jones HJ, Norwood CR, Bankston K, Bakas T. Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. J Cardiovasc Nurs. 2019 Nov/Dec;34(6):483-490. doi: 10.1097/JCN.0000000000000615.</citation>
    <PMID>31609281</PMID>
  </reference>
  <reference>
    <citation>Jones HJ, Sternberg RM, Janson SL, Lee KA. A Qualitative Understanding of Midlife Sources of Stress and Support in African-American Women. J Natl Black Nurses Assoc. 2016 Jul;27(1):24-30.</citation>
    <PMID>29932540</PMID>
  </reference>
  <reference>
    <citation>Jones HJ, Bakas T, Nared S, Humphries J, Wijesooriya J, Butsch Kovacic M. Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. Int J Environ Res Public Health. 2022 Jan 26;19(3):1356. doi: 10.3390/ijerph19031356.</citation>
    <PMID>35162379</PMID>
  </reference>
  <reference>
    <citation>Jones HJ, Kovacic MB, Bakas T. Establishing Validity of the Midlife Black Women's Stress-Reduction Wellness Program Materials Using a Mixed Methods Approach. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):446-455. doi: 10.1097/JCN.0000000000000876. Epub 2021 Dec 22.</citation>
    <PMID>34935740</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <results_first_submitted>August 5, 2022</results_first_submitted>
  <results_first_submitted_qc>January 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 3, 2023</results_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Holly Jones</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Black women</keyword>
  <keyword>Stress</keyword>
  <keyword>Heart disease</keyword>
  <keyword>Health behaviors</keyword>
  <keyword>Midlife</keyword>
  <keyword>Community-based research</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We anticipate that there will be manuscripts, not only from the findings addressing Specific Aims 1 and 2, but also from secondary analyses from data generated from this study. We will disseminate results from Specific Aims 1 and 2, as well as results from secondary analyses, in peer-reviewed journals. We will also make the data available to others. Data will be shared with undergraduate honors students, MSN students, DNP students, PhD students, post-doctoral students, and interested faculty members at the University of Cincinnati, College of Nursing, and other institutions.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will become available upon completion of the study and remain available for 1 year.</ipd_time_frame>
    <ipd_access_criteria>To be determined.</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>February 9, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT04404478/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Women were recruited from the community using fliers, social media, email list serves, and word of mouth. The recruitment efforts were led by community partners. Recruitment was completed within 7 weeks.</recruitment_details>
      <pre_assignment_details>Of the 52 persons randomized and enrolled in the study, 3 persons withdrew prior to the start of the study (week 1) and 1 person was withdrawn prior to week 2 for lack of participation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>B-SWELL Intervention Group (B-SWELL)</title>
          <description>Black women's stress and wellness intervention</description>
        </group>
        <group group_id="P2">
          <title>Wellness (WE)</title>
          <description>Comparison group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>B-SWELL Group</title>
          <description>The Midlife Black women's Stress and Wellness group (B-SWELL) is the intervention group.</description>
        </group>
        <group group_id="B2">
          <title>WE Group</title>
          <description>The Wellness (WE) group is the comparison group.</description>
        </group>
        <group group_id="B3">
          <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="25"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>midlife Black women were recruited between the ages of 40 and 64. Age was self reported using month and birth year.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Age between 40 and 64</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>American Heart Association's Life's Simple Seven (LS7) Score</title>
        <description>Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>These measures were used to calculate the differences between timepoints for the two groups.</population>
        <group_list>
          <group group_id="O1">
            <title>B-SWELL</title>
            <description>Participants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.&#xD;
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.</description>
          </group>
          <group group_id="O2">
            <title>WE (Wellness Comparison Group)</title>
            <description>The attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.&#xD;
WE: Wellness program for Midlife Black Women: Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.</description>
          </group>
        </group_list>
        <measure>
          <title>American Heart Association's Life's Simple Seven (LS7) Score</title>
          <description>Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.</description>
          <population>These measures were used to calculate the differences between timepoints for the two groups.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.76" spread="2.11"/>
                    <measurement group_id="O2" value="8.21" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unhealthy Days</title>
        <description>'Unhealthy Days' is measures by the number of unhealthy days reported by the participant. This question asks the participant how many days in past month that their physical/mental health was not good. This is a continuous numeric response. Higher numbers indicate poorer health during the reported timeframe.</description>
        <time_frame>baseline to 12 weeks</time_frame>
        <population>The number of unhealthy days measured within 2 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>B-SWELL</title>
            <description>Participants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.&#xD;
B-SWELL: Midlife Black Women's Stress Reduction Wellness Program: Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.</description>
          </group>
          <group group_id="O2">
            <title>WE (Wellness Comparison Group)</title>
            <description>The attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.&#xD;
WE: Wellness program for Midlife Black Women: Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.</description>
          </group>
        </group_list>
        <measure>
          <title>Unhealthy Days</title>
          <description>'Unhealthy Days' is measures by the number of unhealthy days reported by the participant. This question asks the participant how many days in past month that their physical/mental health was not good. This is a continuous numeric response. Higher numbers indicate poorer health during the reported timeframe.</description>
          <population>The number of unhealthy days measured within 2 weeks.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.52" spread="6.26"/>
                    <measurement group_id="O2" value="3.09" spread="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived General Health</title>
        <description>The Perceived General Health question is one item from the Short Form Health Survey. The participants will rate their health as 'excellent', 'very good', 'good', 'fair' and 'poor'. Responses are categorical. The reported outcome reflects the number of participants who rate their health as 'good'.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>B-SWELL</title>
            <description>Intervention group</description>
          </group>
          <group group_id="O2">
            <title>WE - Wellness Group</title>
            <description>comparison group</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived General Health</title>
          <description>The Perceived General Health question is one item from the Short Form Health Survey. The participants will rate their health as 'excellent', 'very good', 'good', 'fair' and 'poor'. Responses are categorical. The reported outcome reflects the number of participants who rate their health as 'good'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health Questionnaire (PHQ9)</title>
        <description>The PHQ9 measures depressive symptoms. Participants rate their depressive symptoms from '0' (not at all) to '3' (every day). Scores range from 0 to 27. Higher scores indicate greater risk of clinical depression. Lower scores indicate less risk for depression.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>B-SWELL</title>
            <description>Intervention group</description>
          </group>
          <group group_id="O2">
            <title>WE - Wellness Group</title>
            <description>comparison group</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire (PHQ9)</title>
          <description>The PHQ9 measures depressive symptoms. Participants rate their depressive symptoms from '0' (not at all) to '3' (every day). Scores range from 0 to 27. Higher scores indicate greater risk of clinical depression. Lower scores indicate less risk for depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.80" spread="5.17"/>
                    <measurement group_id="O2" value="5.39" spread="3.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cohen's Perceived Stress Scale (PSS-10)</title>
        <description>The Perceived stress scale (PSS-10) measures a person's perception of general stress. Items are rated on a scale of 0 to 4 with a maximum score of 40. Higher levels of stress correspond with higher scores. Low scores indicate less stress.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>B-SWELL</title>
            <description>Intervention group</description>
          </group>
          <group group_id="O2">
            <title>WE - Wellness Group</title>
            <description>comparison group</description>
          </group>
        </group_list>
        <measure>
          <title>Cohen's Perceived Stress Scale (PSS-10)</title>
          <description>The Perceived stress scale (PSS-10) measures a person's perception of general stress. Items are rated on a scale of 0 to 4 with a maximum score of 40. Higher levels of stress correspond with higher scores. Low scores indicate less stress.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.68" spread="6.32"/>
                    <measurement group_id="O2" value="15.39" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>General Self-Efficacy Scale (GSE)</title>
        <description>The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with life demands. The total score is calculated by finding the sum of the all items. Scores range from 1 (not at all true) to 4 (exactly true). Total scores range between 10 and 40. A higher score indicates greater self-efficacy in achieving a particular outcome. Lower scores indicate the participant has less self-efficacy in achieving the outcome.</description>
        <time_frame>baseline to 12 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>B-SWELL</title>
            <description>Intervention group</description>
          </group>
          <group group_id="O2">
            <title>WE - Wellness Group</title>
            <description>comparison group</description>
          </group>
        </group_list>
        <measure>
          <title>General Self-Efficacy Scale (GSE)</title>
          <description>The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with life demands. The total score is calculated by finding the sum of the all items. Scores range from 1 (not at all true) to 4 (exactly true). Total scores range between 10 and 40. A higher score indicates greater self-efficacy in achieving a particular outcome. Lower scores indicate the participant has less self-efficacy in achieving the outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.44" spread="3.36"/>
                    <measurement group_id="O2" value="32.91" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Satisfaction (Adapted From Satisfaction Questionnaire).</title>
        <description>Satisfaction. Participants rate their satisfaction of the overall B-SWELL program using a Likert type scale ranging from 1=strongly disagree to 5=strongly agree. The questionnaire includes items for usefulness, ease of use, and acceptability of the intervention. Ratings are averaged across participants.&#xD;
The results reported here refer to the question: 'The weekly program materials addressed the problems I was having as a midlife Black woman.'</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>B-SWELL</title>
            <description>Intervention group</description>
          </group>
          <group group_id="O2">
            <title>WE - Wellness Group</title>
            <description>comparison group</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction (Adapted From Satisfaction Questionnaire).</title>
          <description>Satisfaction. Participants rate their satisfaction of the overall B-SWELL program using a Likert type scale ranging from 1=strongly disagree to 5=strongly agree. The questionnaire includes items for usefulness, ease of use, and acceptability of the intervention. Ratings are averaged across participants.&#xD;
The results reported here refer to the question: 'The weekly program materials addressed the problems I was having as a midlife Black woman.'</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="0.92"/>
                    <measurement group_id="O2" value="4.30" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks: Time point 1 (0 weeks), Time point 2 ( 8 weeks), and Timepoint 3 (12 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>B-SWELL</title>
          <description>Intervention group</description>
        </group>
        <group group_id="E2">
          <title>WE - Wellness Group</title>
          <description>comparison group</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <limitations_and_caveats>Limitations include:&#xD;
The comparison group included culturally tailored materials and was not a true control.&#xD;
The effects of peer support and group interactions may have been underestimated in the WE group.&#xD;
The threat of group contamination could not be eliminated.&#xD;
The small sample in this feasibility study prohibits our ability to make inferences.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Holly Jones</name_or_title>
      <organization>Ohio State University</organization>
      <phone>760-415-6147</phone>
      <email>jones.7935@osu.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/NCT04404478
org study id: B-SWELL2019
secondary id: K01HL141676
nct id: NCT04404478
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study examines the unique cultural and gender-based factors that influence how
      midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily
      life. The B-SWELL intervention uses stress reduction and goal setting to increase self
      efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared
      to an inattention control wellness group in a randomized control trial. The long-term outcome
      is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.
Cardiovascular disease (CVD) is the primary cause of death in all women, and as women
      transition through midlife, the prevalence of CVD exceeds that of men.1 Midlife Black women,
      defined as ages 40-64,unduly shoulder the burden of CVD (49%), hypertension (40%), and heart
      failure (50% greater risk). Midlife Black women also report higher levels of chronic stress
      and greater numbers of stressful life events in comparison to midlife White women, putting
      them at greater risk for CVD. In addition to the physical impact, coping with chronic stress
      takes time and energy away from self-care, functioning as a barrier to the adoption of
      healthy lifestyle behaviors. Existent interventions do not fully address the unique factors
      contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black
      women.

      The purpose of this research proposal is to develop a midlife Black women's Stress-reduction
      WELLness intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors
      and themes identified in preliminary research. Community-based participatory research (CBPR)
      methods will be used to engage the community and include midlife Black women in the
      development of the B-SWELL. We propose that the skills and knowledge gained through
      participation in the B-SWELL program will increase receptivity to the healthy lifestyle
      behaviors outlined in the American Heart Association's Life Simple 7 Success Plan (LS7). The
      LS7 targets seven risk factors known to increase cardiovascular related health risk:
      cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and
      smoking.

      Our hypothesis proposes that low stress scores and greater self efficacy will be associated
      with the adoption of AHA's healthy lifestyle behaviors. Low stress and self efficacy will be
      facilitated through peer support and culturally relevant content, materials, and themes.
      B-SWELL participants will show improved self-efficacy in managing life stress and adopting
      the LS7 behaviors, compared to a control group receiving traditional wellness education (WE
      group).

      Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative
      leveraging of CBPR methodology and LS7 modifiable healthy lifestyle behaviors.

        1. To develop components of the B-SWELL intervention prototype for midlife Black women.

        2. Obtain ratings of the new components of the B-SWELL from our community advisory board
           for degree of accuracy, relevance, and feasibility to inform further refinements.

      Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black
      women randomized to the B-SWELL intervention (25) or to a wellness education (WE) control
      group (25):

        1. Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for
           the intervention procedures for both groups;

        2. Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL
           intervention group with those in the WE group at 8 and 12 weeks.

        3. Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive
           symptoms) for participants in the B-SWELL intervention group with those in the WE
           attention control group at 8 and 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial comparing intervention group (B-SWELL) with an attention control group (WE) to assess the following outcomes: healthy lifestyle scores, perceived stress scores, self efficacy, unhealthy days, and depressive symptoms.
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: The participants will be randomized into groups. Group sessions held online on different dates and times. Participants are asked not to share details about the study. Data collectors are blinded to participant grouping. Facilitators are blinded to the groups they are not facilitating.
measure: American Heart Association's Life's Simple Seven (LS7) Score
time frame: Baseline to 12 weeks
description: Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.
measure: Unhealthy Days
time frame: baseline to 12 weeks
description: 'Unhealthy Days' is measures by the number of unhealthy days reported by the participant. This question asks the participant how many days in past month that their physical/mental health was not good. This is a continuous numeric response. Higher numbers indicate poorer health during the reported timeframe.
measure: Perceived General Health
time frame: Baseline to 12 weeks
description: The Perceived General Health question is one item from the Short Form Health Survey. The participants will rate their health as 'excellent', 'very good', 'good', 'fair' and 'poor'. Responses are categorical. The reported outcome reflects the number of participants who rate their health as 'good'.
measure: Patient Health Questionnaire (PHQ9)
time frame: Baseline to 12 weeks
description: The PHQ9 measures depressive symptoms. Participants rate their depressive symptoms from '0' (not at all) to '3' (every day). Scores range from 0 to 27. Higher scores indicate greater risk of clinical depression. Lower scores indicate less risk for depression.
measure: Cohen's Perceived Stress Scale (PSS-10)
time frame: Baseline to 12 weeks
description: The Perceived stress scale (PSS-10) measures a person's perception of general stress. Items are rated on a scale of 0 to 4 with a maximum score of 40. Higher levels of stress correspond with higher scores. Low scores indicate less stress.
measure: General Self-Efficacy Scale (GSE)
time frame: baseline to 12 weeks.
description: The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with life demands. The total score is calculated by finding the sum of the all items. Scores range from 1 (not at all true) to 4 (exactly true). Total scores range between 10 and 40. A higher score indicates greater self-efficacy in achieving a particular outcome. Lower scores indicate the participant has less self-efficacy in achieving the outcome.
measure: Satisfaction (Adapted From Satisfaction Questionnaire).
time frame: 8 weeks
description: Satisfaction. Participants rate their satisfaction of the overall B-SWELL program using a Likert type scale ranging from 1=strongly disagree to 5=strongly agree. The questionnaire includes items for usefulness, ease of use, and acceptability of the intervention. Ratings are averaged across participants.
The results reported here refer to the question: 'The weekly program materials addressed the problems I was having as a midlife Black woman.'
arm group label: B-SWELL
arm group type: Experimental
description: Participants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.
arm group label: WE
arm group type: Active Comparator
description: The attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks.
intervention type: Behavioral
intervention name: B-SWELL: Midlife Black Women's Stress Reduction Wellness Program
description: Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.
arm group label: B-SWELL
intervention type: Behavioral
intervention name: WE: Wellness program for Midlife Black Women
description: Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.
arm group label: WE
criteria: 
gender: Female
gender based: Yes
gender description: Midlife Black/African-American women between the ages of 40 and 64,
minimum age: 40 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Holly J Jones, PhD,RN,NP
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
citation: Jones HJ, Norwood CR, Bankston K. Leveraging Community Engagement to Develop Culturally Tailored Stress Management Interventions in Midlife Black Women. J Psychosoc Nurs Ment Health Serv. 2019 Mar 1;57(3):32-38. doi: 10.3928/02793695-20180925-01. Epub 2018 Oct 1.
PMID: 30272812
citation: Jones HJ, Norwood CR, Bankston K, Bakas T. Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. J Cardiovasc Nurs. 2019 Nov/Dec;34(6):483-490. doi: 10.1097/JCN.0000000000000615.
PMID: 31609281
citation: Jones HJ, Sternberg RM, Janson SL, Lee KA. A Qualitative Understanding of Midlife Sources of Stress and Support in African-American Women. J Natl Black Nurses Assoc. 2016 Jul;27(1):24-30.
PMID: 29932540
citation: Jones HJ, Bakas T, Nared S, Humphries J, Wijesooriya J, Butsch Kovacic M. Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. Int J Environ Res Public Health. 2022 Jan 26;19(3):1356. doi: 10.3390/ijerph19031356.
PMID: 35162379
citation: Jones HJ, Kovacic MB, Bakas T. Establishing Validity of the Midlife Black Women's Stress-Reduction Wellness Program Materials Using a Mixed Methods Approach. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):446-455. doi: 10.1097/JCN.0000000000000876. Epub 2021 Dec 22.
PMID: 34935740
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Holly Jones
investigator title: Assistant Professor
mesh term: Depression
sharing ipd: Yes
ipd description: We anticipate that there will be manuscripts, not only from the findings addressing Specific Aims 1 and 2, but also from secondary analyses from data generated from this study. We will disseminate results from Specific Aims 1 and 2, as well as results from secondary analyses, in peer-reviewed journals. We will also make the data available to others. Data will be shared with undergraduate honors students, MSN students, DNP students, PhD students, post-doctoral students, and interested faculty members at the University of Cincinnati, College of Nursing, and other institutions.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will become available upon completion of the study and remain available for 1 year.
ipd access criteria: To be determined.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations include:
The comparison group included culturally tailored materials and was not a true control.
The effects of peer support and group interactions may have been underestimated in the WE group.
The threat of group contamination could not be eliminated.
The small sample in this feasibility study prohibits our ability to make inferences.
point of contact: 