xml: <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/NCT05997888</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00019542</org_study_id>
      <nct_id>NCT05997888</nct_id>
    </id_info>
    <brief_title>Feasibility, Acceptability, and Preliminary Efficacy of a Six-week Physical Activity Intervention for Black Women</brief_title>
    <official_title>Examining the Feasibility, Acceptability, and Preliminary Efficacy of a Six-week At-home Strength Training Intervention for Black Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Minnesota</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>
        The current study will be a randomized controlled pilot study conducted in the Midwest.&#xD;
        Participants will be randomly assigned to a behavioral intervention or a wait-list control&#xD;
        group, each lasting six weeks. The intervention group will first have an in-person meeting at&#xD;
        the beginning of the intervention to discuss the study, go over movements, and discuss Zoom&#xD;
        and WhatsApp instructions. The behavioral intervention will consist of three home-based&#xD;
        workouts per week sent digitally and Zoom session per week that will have an exercise session&#xD;
        and a group counseling session. Additionally, each week participants will be sent a&#xD;
        motivational prompt via WhatsApp and will be encouraged to connect with each other about&#xD;
        physical activity motivation, barriers, and facilitators. Acceptability, physical activity&#xD;
        and psychosocial variables of interest will be measured via accelerometer data (via Actigraph&#xD;
        GT3X) and self-report at baseline and six weeks (post-intervention). Focus groups will be&#xD;
        conducted for all participants at the conclusion of the study to further assess&#xD;
        acceptability, feasibility, and efficacy of the program.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Step 1- Formative Focus Groups: Prior to recruitment of participants, three focus groups with&#xD;
        five to eight members of the target population per group will be conducted to accomplish the&#xD;
        following: 1) Review intervention materials such as exercise session content, motivational&#xD;
        construct activities, and counseling session topics, and 2) assess any barriers and&#xD;
        facilitators within their environments that should be accounted for in the methodology of the&#xD;
        study, and 3) to explore how racism impacts their lives and how their ability to engage in&#xD;
        physical activity. A trained consultant will ask questions regarding length of workouts,&#xD;
        frequency of messaging on WhatsApp, whether video calls between participants and the PI would&#xD;
        be helpful, and what type of messaging and video content the participants may like to see, in&#xD;
        accordance with similar literature in the field (Joseph et al., 2017). Formative research&#xD;
        participants will be paid $20 for their time. After the focus groups conclude, the PI and&#xD;
        another researcher will conduct inductive hierarchical content analysis to incorporate&#xD;
        results into the intervention structure and design. Audio and/or video recordings will be&#xD;
        taken in order to accurately analyze themes and adjust the protocol based on answers from the&#xD;
        focus groups. The protocol of the intervention will be adjusted with results from the&#xD;
        formative focus groups after receiving relevant input.&#xD;
  &#xD;
        Step 2- Telephone Screening, Consent, and Baseline Questionnaires: In response to&#xD;
        advertisement and outreach efforts, potential participants will call, email, or text the&#xD;
        Student Investigator (SI), at which time they will complete a telephone screening interview&#xD;
        with the SI to determine eligibility for the study. Participants who are eligible will be&#xD;
        given detailed information about the study and the consent form will be reviewed. The SI will&#xD;
        schedule a randomization appointment in two weeks. Participants will be told that they may&#xD;
        need to cancel the appointment if the online consent and questionnaires are not completed.&#xD;
  &#xD;
        a) Complete telephone screening&#xD;
  &#xD;
          1. If not eligible, end interview and thank them for their time&#xD;
  &#xD;
          2. If eligible:&#xD;
  &#xD;
        i. Schedule randomization appointment for 2 weeks ii. Email link to consent form and&#xD;
        questionnaires iii. Explain ActiGraph procedures. The Actigraph is a small device that is&#xD;
        attached to the participant's clothing/belt at the waist and measures physical activity&#xD;
        amount and intensity. The Actigraph functions as a method of measuring physical activity with&#xD;
        the purpose of obtaining objective measurement of the participants' physical activity.&#xD;
  &#xD;
        Step 3- Send Actigraph: Upon completion of the consent form and questionnaires, send the&#xD;
        Actigraph assessment with instructions and return envelope.&#xD;
  &#xD;
        Step 4- Check on consent and baseline questionnaires: If the ActiGraph is not received by the&#xD;
        randomization appointment, the participant is to be called to cancel the appointment. The&#xD;
        participant should be told that they will be called to reschedule the appointment once the&#xD;
        ActiGraph is received.&#xD;
  &#xD;
          1. Once the ActiGraph is received, call the participant to schedule a time or if time&#xD;
             permits, complete the randomization appointment at the time of the initial call.&#xD;
  &#xD;
          2. If the ActiGraph has been received, proceed with the scheduled randomization&#xD;
             appointment.&#xD;
  &#xD;
        Step 5- Baseline Session:&#xD;
  &#xD;
        1) Participants are randomly assigned to either the exercise or wait-list control condition.&#xD;
        The wait-list control condition will have the option of receiving the exercise intervention&#xD;
        after the 6 weeks. The exercise intervention will be delivered via phone. Enter randomization&#xD;
        date in REDcap.&#xD;
  &#xD;
          1. Script: &quot;The next thing we are going to do is to find out which of the two groups you&#xD;
             have been randomly assigned to. This is completely random and unfortunately I have no&#xD;
             control over which group you are assigned to. Let me access my form here to determine&#xD;
             which program you are in.&quot;&#xD;
  &#xD;
          2. Exercise: &quot;You have been randomly assigned to the exercise program. This program is&#xD;
             designed to help you increase your exercise. I will work with you to make a plan on how&#xD;
             you are going to fit exercise into your day. Do you have any questions before we start?&quot;&#xD;
  &#xD;
          3. Wait-List Control: &quot;You have been randomly assigned to the wait-list control condition.&#xD;
             This means that you will be contacted again in 6 weeks to complete your assessment.&#xD;
             After your assessment, you will complete the exercise program if you would like to.&quot;&#xD;
  &#xD;
        Step 6- Intervention Sessions (separate protocol is attached to submission):&#xD;
  &#xD;
          1. The participant will be told when exercise should be stopped for safety reasons in order&#xD;
             to minimize risk to the participant.&#xD;
  &#xD;
          2. Baseline fitness will be assessed with a sit up and push up test (to assess strength and&#xD;
             endurance) prior to the first meeting (this will be scheduled).&#xD;
  &#xD;
          3. Participants randomly assigned to the behavioral intervention will begin with a 90&#xD;
             minute in-person meeting at a community space with all intervention participants, the&#xD;
             SI, and the trained research assistant. At this meeting, participants will have time to&#xD;
             meet each other and the researchers, and refreshments will be provided by the research&#xD;
             team. The research team will show all participants how to download WhatsApp and join the&#xD;
             group chat. Participants will also be instructed to use their first name only in the&#xD;
             WhatsApp group chat in order to maintain confidentiality. Then, proper form for common&#xD;
             movements that will be used in the intervention, such as squats, lunges, push-ups, and&#xD;
             exercises with bands will be demonstrated and practiced by all participants. While&#xD;
             participants practice these movements, the research team will provide feedback on&#xD;
             exercise form to ensure that participants are using safe and proper techniques to avoid&#xD;
             injury. Additionally, participants will receive information regarding the benefits of&#xD;
             physical activity for physical and mental health, and will be encouraged to ask any&#xD;
             questions they may have about the intervention or physical activity for health. Finally,&#xD;
             all participants will be asked if they have any questions, and the PI will facilitate&#xD;
             any questions and discussion during this time.&#xD;
  &#xD;
          4. On Monday of each week, participants will be sent five workouts per week (depending on&#xD;
             results from the focus groups) to their emails. All workouts will vary by time, number&#xD;
             of exercises, and muscle group focus, but all involve bodyweight and banded strength&#xD;
             exercises designed to be low intensity. Variations will be provided, and participants&#xD;
             will be free to choose the variation that fits their comfortability level (e.g. push-up&#xD;
             versus knee push-up). All workouts will slightly increase in difficulty each week in&#xD;
             regard to repetition numbers and workout length but will have similar movements and&#xD;
             structure. Workouts will either be targeted toward a specific muscle group or various&#xD;
             muscle groups will be combined into one session. Of the five workouts sent per week,&#xD;
             participants will be asked to complete two in the first half of the intervention (weeks&#xD;
             one through three) and three in the second half of the intervention (weeks four through&#xD;
             six).&#xD;
  &#xD;
          5. Participants will be sent short motivational prompts via WhatApp (depending on results&#xD;
             from the focus groups) on Monday of each week that target constructs of self-efficacy&#xD;
             and motivation, as informed by Self-Efficacy Theory and Self-Determination Theory.&#xD;
             Participants will be encouraged to respond to the prompt in the group and chat with each&#xD;
             other as much as they want during each week. The SI will not participate in the group&#xD;
             beyond sending a motivational prompt each week, and any questions for the PI will be&#xD;
             answered via email so as not to interrupt the flow of engagement between participants.&#xD;
             On each Monday, participants will also be instructed to send the SI which workouts they&#xD;
             completed and on which days of the week.&#xD;
  &#xD;
          6. Participants in the intervention group will engage in one 60-minute Zoom session per&#xD;
             week to foster connectivity between participants and the research team. In the first 25&#xD;
             minutes, participants will engage in group counseling based on the motivational prompts&#xD;
             sent out on Monday. After the counseling session, participants will then engage a&#xD;
             25-minute group exercise session that is similar to the sample workouts in regard to&#xD;
             difficulty. Before the start of the exercise session, participants will be told to stop&#xD;
             exercising if they experience shortness of breath, chest pain, and/or pain radiating&#xD;
             down one arm, dizziness, muscle weakness, calf pain, or a headache. The first five&#xD;
             minutes will be dedicated to stretching and warming up. The exercise session will last&#xD;
             approximately 25 minutes, with twenty minutes for the main exercise session and five&#xD;
             minutes will be a cool down and debrief of the session. During the exercise portion of&#xD;
             the meeting, all participants will complete the Feeling Scale (FS) to assess feelings at&#xD;
             different points of the exercise session. In the group counseling sessions, participants&#xD;
             will engage in activities related to motivation for physical activity and they will work&#xD;
             together to discuss how to overcome barriers to physical activity.&#xD;
  &#xD;
        Step 7- 6-week assessment:&#xD;
  &#xD;
          1. At 5 weeks, the participant will be mailed to the ActiGraph, which will be worn for one&#xD;
             week starting the day after the last intervention session.&#xD;
  &#xD;
          2. At 6 weeks, the participant will be prompted to complete the 6-week questionnaire.&#xD;
  &#xD;
          3. The participant will be sent a $50 gift card once the assessment is complete and the&#xD;
             ActiGraph is received.&#xD;
  &#xD;
        Step 8- Post-Intervention Focus Group&#xD;
  &#xD;
        1) At the conclusion of the intervention, the intervention group will undergo a one-hour&#xD;
        focus group that will ask various questions regarding the intervention. These focus groups&#xD;
        may be audio and/or video recorded (questions attached to submission)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">April 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 10, 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of the programs</measure>
      <time_frame>Six weeks</time_frame>
      <description>Customer satisfaction. Feasibility of the intervention will be measured by looking at acceptability and implementation of the intervention. Level of acceptability will be assessed by examining the percentage of Zoom sessions (both group and individual) attended and self-reported number of exercise sessions completed per week. This measure will be assessed on a 1-7 point Likert scale, with one = &quot;very dissatisfied&quot; to seven = &quot;very satisfied&quot;. Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>Six weeks</time_frame>
      <description>Acceptability will also be assessed with a customer satisfaction form, which asks participants to respond on a seven-point Likert scale, with one = &quot;very dissatisfied&quot; to seven = &quot;very satisfied&quot;. Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Social support</measure>
      <time_frame>six weeks</time_frame>
      <description>Physical Activity Social Support (PASS). The PASS scale, created by Sallis et al. (1987) and also based on SCT, is a 13-item measure that assesses family and peer support for physical activity within the past month. PASS asks respondents to gauge support with statements such as &quot;did physical activity with me&quot; and &quot;criticized or made fun of me for doing physical activities&quot; on a 5-point Likert scale ranging from 0 (none) to 4 (very often). The PASS has shown empirical validity and high test-retest reliability (Sallis et al., 1987). Additionally, the PASS has had internal consistency scores ranging from ɑ = 0.61 to ɑ = 0.84 (Sallis et al., 1987).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral regulation</measure>
      <time_frame>six weeks</time_frame>
      <description>The Behavioral Regulation in Exercise Scale (BREQ-2, Markland &amp; Tobin, 2004) was built off of Deci &amp; Ryan's (2000) Self-Determination Theory to assess motivation for physical activity. The BREQ-2 consists of 19 items that ask why respondents exercise and assess motivation along a self-determination continuum of amotivation, external motivation, introjection, identification, integration, and intrinsic regulation. Respondents are asked whether statements on a scale of one (&quot;not true for me&quot;) to four (&quot;very true for me&quot;). Internal consistency was above the standard for the field, ɑ = 0.749-0.849 (D'Abundo et al., 2014). The BREQ-2 has demonstrated sufficient reliability and validity (Markland &amp; Tobin, 2004; Teixeira et al., 2012).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Enjoyment</measure>
      <time_frame>six weeks</time_frame>
      <description>Physical Activity Enjoyment Scale (PACES). The Physical Activity Enjoyment Scale (PACES), created by Kendzierski &amp; DeCarlo (1991), is an 18-item measure to assess perceptions of physical activity. PACES asks respondents to &quot;rate how you feel at the moment about a physical activity you have been doing.&quot; PACES uses a 7-point Likert scale and asks participants to respond to paired statements such as, &quot;I am very absorbed in this activity&quot; versus &quot;I am not at all absorbed in this activity&quot; and &quot;It's very gratifying&quot; versus &quot;It's not at all gratifying.&quot; Eleven of the 18 items are reverse scored. PACES has demonstrated high internal consistency, ɑ = 0.93, and reliability (Kendzierski &amp; DeCarlo, 1991; Motl, 2001). The PACES has demonstrated reliability and validity for various adult populations (Kendzierski &amp; DeCarlo, 1991; Mullen et al., 2011).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>outcome expectations</measure>
      <time_frame>six weeks</time_frame>
      <description>Outcome Expectations for Exercise Scale (OEE). Outcome expectations, or the assessment of the consequences of a behavior, was gauged with the 9-item Outcome Expectations for Exercise Scale (OEES). OEE was developed by Resnick et al. (2001) and is based on Bandura's (1998) Social Cognitive Theory, which postulates that outcome expectations influence physical activity behavior. Five items assess the physical benefits of exercise and four assess the mental benefits of exercise. Respondents are asked to read statements regarding perceived consequences of exercising and indicate on a five-item Likert scale whether they one (strongly agree) to five (strongly disagree). Items include statements such as exercising &quot;makes me feel better physically&quot; and &quot;improves my endurance in performing my daily activities.&quot; The OEE has high internal consistency, ɑ = 0.95, and has been shown to have good validity and reliability in samples similar to the current study (Murrock &amp; Gary, 2014).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>self-efficacy</measure>
      <time_frame>six weeks</time_frame>
      <description>Self-Efficacy. Self-efficacy for exercise will be assessed using a 5-item measure that asks participants to rate their confidence that they will be able to be physically active in five different situations (vacation, being tired, being busy, being in a bad mood, and inclement weather) (Marcus et al., 1992). This five-item likert scale varies from one = &quot;not at all confident&quot; to five = &quot;extremely confident&quot; (Marcus et al., 1992). This measure of self-efficacy has been validated for adult populations and has an internal consistency of ɑ = 0.76 (Marcus et al., 1992; Theodoropoulou et al., 2021).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity</measure>
      <time_frame>six weeks</time_frame>
      <description>The Actigraph GT3X has been empirically validated to objectively measure physical activity for adults (Santos-Lozano et al., 2013). Accelerometers have provided empirically validated data and overcome many problems associated with self-report data, such as overestimation of physical activity (Esliger et al., 2005). 7-Day PAR - This measure asks the participant to recall the amount of time for each day in the past seven days that they engaged in moderate, hard, and very hard physical activity (Washburn et al., 2003). This measure has also shown moderate consistency when compared to accelerometer data (Sloane et al., 2009).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Themes from focus groups</measure>
      <time_frame>six weeks</time_frame>
      <description>Intervention participants will complete a focus group in which we ask various questions surrounding the intervention</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Physical Inactivity</condition>
    <arm_group>
      <arm_group_label>At-Home Strength Training Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this arm will undergo an in-person meeting before the start of the study to meet each other, go over movements to minimize risk of injury, and to discuss intervention logistics. Then, for six weeks, participants will be sent five workouts at the start of each week (Monday). Participants will choose 2 or 3 to complete on their own. Additionally, participants will have a weekly Zoom meeting in which 30 minutes will be dedicated to exercising, and 30 minutes will be for group counseling.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait-List Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This will be a wait-list control group. Participants at the end of the study will have the option to complete the full, partial, or none of the intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>At-Home Strength Training Intervention</intervention_name>
      <description>A six-week strength training intervention in which participants will choose workouts to complete on their own. These workouts are 20-25 minutes light-intensity strength training with light strength bands. Exercises will have multiple options to account for various levels of ability. Additionally, there will be a group counseling session once per week via Zoom and a group strength training program.</description>
      <arm_group_label>At-Home Strength Training Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Identify as Black&#xD;
  &#xD;
            -  Be categorized as insufficiently active, defined as less than 30 minutes of physical&#xD;
               activity and less than two days of strength training&#xD;
  &#xD;
            -  Live in the Twin Cities area&#xD;
  &#xD;
            -  Be at least 18 years-old&#xD;
  &#xD;
            -  Be able to participate in the study for six weeks and agree to participate in a focus&#xD;
               group at the conclusion of the study&#xD;
  &#xD;
            -  Possess a smartphone&#xD;
  &#xD;
            -  Be willing to wear an accelerometer (Actigraph GT3X) for the duration of the study&#xD;
  &#xD;
            -  Be able to attend a weekly 60 minute Zoom session on one of two selected nights&#xD;
  &#xD;
            -  Be willing to be randomized to the intervention or control condition.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Do not identify as Black&#xD;
  &#xD;
            -  Are active over 30 minutes per week&#xD;
  &#xD;
            -  Are under 18 years-old&#xD;
  &#xD;
            -  Will be unable to participate in the full study&#xD;
  &#xD;
            -  Do not possess a smartphone&#xD;
  &#xD;
            -  Are unwilling to wear an accelerometer&#xD;
  &#xD;
            -  Are unwilling to be randomized to either condition&#xD;
  &#xD;
            -  Are pregnant&#xD;
  &#xD;
            -  Have a serious physical or mental condition that would interfere with the ability to&#xD;
               do physical activity&#xD;
  &#xD;
            -  Are currently enrolled in another exercise-related study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Identify as a woman</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Beth Lewis, PhD</last_name>
      <phone>612-625-0756</phone>
      <email>blewis@umn.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kaitlyn Swinney, MA</last_name>
      <phone>7133973018</phone>
      <email>swinn012@umn.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Minnesota</investigator_affiliation>
      <investigator_full_name>Beth Lewis</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997888
  org study id: STUDY00019542
  nct id: NCT05997888
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The current study will be a randomized controlled pilot study conducted in the Midwest.
        Participants will be randomly assigned to a behavioral intervention or a wait-list control
        group, each lasting six weeks. The intervention group will first have an in-person meeting at
        the beginning of the intervention to discuss the study, go over movements, and discuss Zoom
        and WhatsApp instructions. The behavioral intervention will consist of three home-based
        workouts per week sent digitally and Zoom session per week that will have an exercise session
        and a group counseling session. Additionally, each week participants will be sent a
        motivational prompt via WhatsApp and will be encouraged to connect with each other about
        physical activity motivation, barriers, and facilitators. Acceptability, physical activity
        and psychosocial variables of interest will be measured via accelerometer data (via Actigraph
        GT3X) and self-report at baseline and six weeks (post-intervention). Focus groups will be
        conducted for all participants at the conclusion of the study to further assess
        acceptability, feasibility, and efficacy of the program.
  Step 1- Formative Focus Groups: Prior to recruitment of participants, three focus groups with
        five to eight members of the target population per group will be conducted to accomplish the
        following: 1) Review intervention materials such as exercise session content, motivational
        construct activities, and counseling session topics, and 2) assess any barriers and
        facilitators within their environments that should be accounted for in the methodology of the
        study, and 3) to explore how racism impacts their lives and how their ability to engage in
        physical activity. A trained consultant will ask questions regarding length of workouts,
        frequency of messaging on WhatsApp, whether video calls between participants and the PI would
        be helpful, and what type of messaging and video content the participants may like to see, in
        accordance with similar literature in the field (Joseph et al., 2017). Formative research
        participants will be paid $20 for their time. After the focus groups conclude, the PI and
        another researcher will conduct inductive hierarchical content analysis to incorporate
        results into the intervention structure and design. Audio and/or video recordings will be
        taken in order to accurately analyze themes and adjust the protocol based on answers from the
        focus groups. The protocol of the intervention will be adjusted with results from the
        formative focus groups after receiving relevant input.
  
        Step 2- Telephone Screening, Consent, and Baseline Questionnaires: In response to
        advertisement and outreach efforts, potential participants will call, email, or text the
        Student Investigator (SI), at which time they will complete a telephone screening interview
        with the SI to determine eligibility for the study. Participants who are eligible will be
        given detailed information about the study and the consent form will be reviewed. The SI will
        schedule a randomization appointment in two weeks. Participants will be told that they may
        need to cancel the appointment if the online consent and questionnaires are not completed.
  
        a) Complete telephone screening
  
          1. If not eligible, end interview and thank them for their time
  
          2. If eligible:
  
        i. Schedule randomization appointment for 2 weeks ii. Email link to consent form and
        questionnaires iii. Explain ActiGraph procedures. The Actigraph is a small device that is
        attached to the participant's clothing/belt at the waist and measures physical activity
        amount and intensity. The Actigraph functions as a method of measuring physical activity with
        the purpose of obtaining objective measurement of the participants' physical activity.
  
        Step 3- Send Actigraph: Upon completion of the consent form and questionnaires, send the
        Actigraph assessment with instructions and return envelope.
  
        Step 4- Check on consent and baseline questionnaires: If the ActiGraph is not received by the
        randomization appointment, the participant is to be called to cancel the appointment. The
        participant should be told that they will be called to reschedule the appointment once the
        ActiGraph is received.
  
          1. Once the ActiGraph is received, call the participant to schedule a time or if time
             permits, complete the randomization appointment at the time of the initial call.
  
          2. If the ActiGraph has been received, proceed with the scheduled randomization
             appointment.
  
        Step 5- Baseline Session:
  
        1) Participants are randomly assigned to either the exercise or wait-list control condition.
        The wait-list control condition will have the option of receiving the exercise intervention
        after the 6 weeks. The exercise intervention will be delivered via phone. Enter randomization
        date in REDcap.
  
          1. Script: "The next thing we are going to do is to find out which of the two groups you
             have been randomly assigned to. This is completely random and unfortunately I have no
             control over which group you are assigned to. Let me access my form here to determine
             which program you are in."
  
          2. Exercise: "You have been randomly assigned to the exercise program. This program is
             designed to help you increase your exercise. I will work with you to make a plan on how
             you are going to fit exercise into your day. Do you have any questions before we start?"
  
          3. Wait-List Control: "You have been randomly assigned to the wait-list control condition.
             This means that you will be contacted again in 6 weeks to complete your assessment.
             After your assessment, you will complete the exercise program if you would like to."
  
        Step 6- Intervention Sessions (separate protocol is attached to submission):
  
          1. The participant will be told when exercise should be stopped for safety reasons in order
             to minimize risk to the participant.
  
          2. Baseline fitness will be assessed with a sit up and push up test (to assess strength and
             endurance) prior to the first meeting (this will be scheduled).
  
          3. Participants randomly assigned to the behavioral intervention will begin with a 90
             minute in-person meeting at a community space with all intervention participants, the
             SI, and the trained research assistant. At this meeting, participants will have time to
             meet each other and the researchers, and refreshments will be provided by the research
             team. The research team will show all participants how to download WhatsApp and join the
             group chat. Participants will also be instructed to use their first name only in the
             WhatsApp group chat in order to maintain confidentiality. Then, proper form for common
             movements that will be used in the intervention, such as squats, lunges, push-ups, and
             exercises with bands will be demonstrated and practiced by all participants. While
             participants practice these movements, the research team will provide feedback on
             exercise form to ensure that participants are using safe and proper techniques to avoid
             injury. Additionally, participants will receive information regarding the benefits of
             physical activity for physical and mental health, and will be encouraged to ask any
             questions they may have about the intervention or physical activity for health. Finally,
             all participants will be asked if they have any questions, and the PI will facilitate
             any questions and discussion during this time.
  
          4. On Monday of each week, participants will be sent five workouts per week (depending on
             results from the focus groups) to their emails. All workouts will vary by time, number
             of exercises, and muscle group focus, but all involve bodyweight and banded strength
             exercises designed to be low intensity. Variations will be provided, and participants
             will be free to choose the variation that fits their comfortability level (e.g. push-up
             versus knee push-up). All workouts will slightly increase in difficulty each week in
             regard to repetition numbers and workout length but will have similar movements and
             structure. Workouts will either be targeted toward a specific muscle group or various
             muscle groups will be combined into one session. Of the five workouts sent per week,
             participants will be asked to complete two in the first half of the intervention (weeks
             one through three) and three in the second half of the intervention (weeks four through
             six).
  
          5. Participants will be sent short motivational prompts via WhatApp (depending on results
             from the focus groups) on Monday of each week that target constructs of self-efficacy
             and motivation, as informed by Self-Efficacy Theory and Self-Determination Theory.
             Participants will be encouraged to respond to the prompt in the group and chat with each
             other as much as they want during each week. The SI will not participate in the group
             beyond sending a motivational prompt each week, and any questions for the PI will be
             answered via email so as not to interrupt the flow of engagement between participants.
             On each Monday, participants will also be instructed to send the SI which workouts they
             completed and on which days of the week.
  
          6. Participants in the intervention group will engage in one 60-minute Zoom session per
             week to foster connectivity between participants and the research team. In the first 25
             minutes, participants will engage in group counseling based on the motivational prompts
             sent out on Monday. After the counseling session, participants will then engage a
             25-minute group exercise session that is similar to the sample workouts in regard to
             difficulty. Before the start of the exercise session, participants will be told to stop
             exercising if they experience shortness of breath, chest pain, and/or pain radiating
             down one arm, dizziness, muscle weakness, calf pain, or a headache. The first five
             minutes will be dedicated to stretching and warming up. The exercise session will last
             approximately 25 minutes, with twenty minutes for the main exercise session and five
             minutes will be a cool down and debrief of the session. During the exercise portion of
             the meeting, all participants will complete the Feeling Scale (FS) to assess feelings at
             different points of the exercise session. In the group counseling sessions, participants
             will engage in activities related to motivation for physical activity and they will work
             together to discuss how to overcome barriers to physical activity.
  
        Step 7- 6-week assessment:
  
          1. At 5 weeks, the participant will be mailed to the ActiGraph, which will be worn for one
             week starting the day after the last intervention session.
  
          2. At 6 weeks, the participant will be prompted to complete the 6-week questionnaire.
  
          3. The participant will be sent a $50 gift card once the assessment is complete and the
             ActiGraph is received.
  
        Step 8- Post-Intervention Focus Group
  
        1) At the conclusion of the intervention, the intervention group will undergo a one-hour
        focus group that will ask various questions regarding the intervention. These focus groups
        may be audio and/or video recorded (questions attached to submission)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Feasibility of the programs
  time frame: Six weeks
  description: Customer satisfaction. Feasibility of the intervention will be measured by looking at acceptability and implementation of the intervention. Level of acceptability will be assessed by examining the percentage of Zoom sessions (both group and individual) attended and self-reported number of exercise sessions completed per week. This measure will be assessed on a 1-7 point Likert scale, with one = "very dissatisfied" to seven = "very satisfied". Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.
  measure: Acceptability
  time frame: Six weeks
  description: Acceptability will also be assessed with a customer satisfaction form, which asks participants to respond on a seven-point Likert scale, with one = "very dissatisfied" to seven = "very satisfied". Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.
  measure: Social support
  time frame: six weeks
  description: Physical Activity Social Support (PASS). The PASS scale, created by Sallis et al. (1987) and also based on SCT, is a 13-item measure that assesses family and peer support for physical activity within the past month. PASS asks respondents to gauge support with statements such as "did physical activity with me" and "criticized or made fun of me for doing physical activities" on a 5-point Likert scale ranging from 0 (none) to 4 (very often). The PASS has shown empirical validity and high test-retest reliability (Sallis et al., 1987). Additionally, the PASS has had internal consistency scores ranging from ɑ = 0.61 to ɑ = 0.84 (Sallis et al., 1987).
  measure: Behavioral regulation
  time frame: six weeks
  description: The Behavioral Regulation in Exercise Scale (BREQ-2, Markland & Tobin, 2004) was built off of Deci & Ryan's (2000) Self-Determination Theory to assess motivation for physical activity. The BREQ-2 consists of 19 items that ask why respondents exercise and assess motivation along a self-determination continuum of amotivation, external motivation, introjection, identification, integration, and intrinsic regulation. Respondents are asked whether statements on a scale of one ("not true for me") to four ("very true for me"). Internal consistency was above the standard for the field, ɑ = 0.749-0.849 (D'Abundo et al., 2014). The BREQ-2 has demonstrated sufficient reliability and validity (Markland & Tobin, 2004; Teixeira et al., 2012).
  measure: Enjoyment
  time frame: six weeks
  description: Physical Activity Enjoyment Scale (PACES). The Physical Activity Enjoyment Scale (PACES), created by Kendzierski & DeCarlo (1991), is an 18-item measure to assess perceptions of physical activity. PACES asks respondents to "rate how you feel at the moment about a physical activity you have been doing." PACES uses a 7-point Likert scale and asks participants to respond to paired statements such as, "I am very absorbed in this activity" versus "I am not at all absorbed in this activity" and "It's very gratifying" versus "It's not at all gratifying." Eleven of the 18 items are reverse scored. PACES has demonstrated high internal consistency, ɑ = 0.93, and reliability (Kendzierski & DeCarlo, 1991; Motl, 2001). The PACES has demonstrated reliability and validity for various adult populations (Kendzierski & DeCarlo, 1991; Mullen et al., 2011).
  measure: outcome expectations
  time frame: six weeks
  description: Outcome Expectations for Exercise Scale (OEE). Outcome expectations, or the assessment of the consequences of a behavior, was gauged with the 9-item Outcome Expectations for Exercise Scale (OEES). OEE was developed by Resnick et al. (2001) and is based on Bandura's (1998) Social Cognitive Theory, which postulates that outcome expectations influence physical activity behavior. Five items assess the physical benefits of exercise and four assess the mental benefits of exercise. Respondents are asked to read statements regarding perceived consequences of exercising and indicate on a five-item Likert scale whether they one (strongly agree) to five (strongly disagree). Items include statements such as exercising "makes me feel better physically" and "improves my endurance in performing my daily activities." The OEE has high internal consistency, ɑ = 0.95, and has been shown to have good validity and reliability in samples similar to the current study (Murrock & Gary, 2014).
  measure: self-efficacy
  time frame: six weeks
  description: Self-Efficacy. Self-efficacy for exercise will be assessed using a 5-item measure that asks participants to rate their confidence that they will be able to be physically active in five different situations (vacation, being tired, being busy, being in a bad mood, and inclement weather) (Marcus et al., 1992). This five-item likert scale varies from one = "not at all confident" to five = "extremely confident" (Marcus et al., 1992). This measure of self-efficacy has been validated for adult populations and has an internal consistency of ɑ = 0.76 (Marcus et al., 1992; Theodoropoulou et al., 2021).
  measure: Physical Activity
  time frame: six weeks
  description: The Actigraph GT3X has been empirically validated to objectively measure physical activity for adults (Santos-Lozano et al., 2013). Accelerometers have provided empirically validated data and overcome many problems associated with self-report data, such as overestimation of physical activity (Esliger et al., 2005). 7-Day PAR - This measure asks the participant to recall the amount of time for each day in the past seven days that they engaged in moderate, hard, and very hard physical activity (Washburn et al., 2003). This measure has also shown moderate consistency when compared to accelerometer data (Sloane et al., 2009).
  measure: Themes from focus groups
  time frame: six weeks
  description: Intervention participants will complete a focus group in which we ask various questions surrounding the intervention
  arm group label: At-Home Strength Training Group
  arm group type: Experimental
  description: Participants in this arm will undergo an in-person meeting before the start of the study to meet each other, go over movements to minimize risk of injury, and to discuss intervention logistics. Then, for six weeks, participants will be sent five workouts at the start of each week (Monday). Participants will choose 2 or 3 to complete on their own. Additionally, participants will have a weekly Zoom meeting in which 30 minutes will be dedicated to exercising, and 30 minutes will be for group counseling.
  arm group label: Wait-List Control Group
  arm group type: No Intervention
  description: This will be a wait-list control group. Participants at the end of the study will have the option to complete the full, partial, or none of the intervention.
  intervention type: Behavioral
  intervention name: At-Home Strength Training Intervention
  description: A six-week strength training intervention in which participants will choose workouts to complete on their own. These workouts are 20-25 minutes light-intensity strength training with light strength bands. Exercises will have multiple options to account for various levels of ability. Additionally, there will be a group counseling session once per week via Zoom and a group strength training program.
  arm group label: At-Home Strength Training Group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Identify as a woman
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Beth Lewis, PhD
  phone: 612-625-0756
  email: blewis@umn.edu
  last name: Kaitlyn Swinney, MA
  phone: 7133973018
  email: swinn012@umn.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Minnesota
  investigator full name: Beth Lewis
  investigator title: Principal Investigator
  sharing ipd: No