<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/NCT04487782</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2019-056</org_study_id>
    <nct_id>NCT04487782</nct_id>
  </id_info>
  <brief_title>Pragmatic Weight Loss Intervention During Menopause</brief_title>
  <acronym>WISE</acronym>
  <official_title>Pragmatic Weight Loss Intervention During Menopause</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kara Marlatt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</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 investigators are using a community-based participatory research (CBPR) model to develop&#xD;
      a lifestyle intervention targeting weight loss that is specifically tailored to women in&#xD;
      perimenopause.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a participatory research study which will enroll women (n of up to 56) with&#xD;
      experience of menopause to help identify preferred strategies (modalities) for weight loss,&#xD;
      which will combine calorie (dietary) restriction and exercise tactics.&#xD;
&#xD;
      Aim 1: Explore attitudes and perceptions about weight gain during the menopause transition,&#xD;
      and identify weight loss strategies from the patient (peer) perspective.&#xD;
&#xD;
      - The investigators will apply these learnings: 1) to understand barriers for weight&#xD;
      management during menopause; 2) to establish strategies to guide retention; 3) to finalize&#xD;
      the intervention structure, including feedback on the frequency and duration of the study&#xD;
      visits; and 4) to gather feedback on menopause-specific education resources set to be&#xD;
      provided throughout the intervention.&#xD;
&#xD;
      Aim 2: Engage the Community Advisory Board (CAB) of the Louisiana Clinical and Translational&#xD;
      Center (LA CaTS) to understand scalability and community-based implementation of an&#xD;
      intervention tailored for women in perimenopause.&#xD;
&#xD;
      - The investigators will then utilize the Louisiana Clinical &amp; Translational Science Center&#xD;
      (LA CaTS) Community Advisory Board (CAB) to help us tailor a lifestyle intervention in&#xD;
      perimenopausal women with emphasis on scalability and community-based implementation using&#xD;
      learnings obtained from the focus groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2020</start_date>
  <completion_date type="Actual">March 10, 2021</completion_date>
  <primary_completion_date type="Actual">March 10, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Duration</measure>
    <time_frame>1 day</time_frame>
    <description>Identify how long would women prefer the intervention to last (e.g., number of months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motivation</measure>
    <time_frame>1 day</time_frame>
    <description>Identify what motivates women (e.g., group setting, incentives, etc.).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time Commitment</measure>
    <time_frame>1 day</time_frame>
    <description>Identify how many times (e.g., days per week) that women would want to participate in a lifestyle intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diet</measure>
    <time_frame>1 day</time_frame>
    <description>Identify the types of diets (e.g., keto, Mediterranean, intermittent fasting, etc.) that women have attempted before, and which diets they liked best.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise</measure>
    <time_frame>1 day</time_frame>
    <description>Identify the types of exercises (e.g., swimming, walking, weight training, etc.) that women like to do or would like to try.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Location</measure>
    <time_frame>1 day</time_frame>
    <description>Identify where women would want to go to receive a lifestyle intervention (e.g., at Pennington, in local fitness centers, virtual/online, etc.).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers</measure>
    <time_frame>1 day</time_frame>
    <description>Identify specific barriers that women would encounter if participating in a lifestyle intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Menopause Education</measure>
    <time_frame>1 day</time_frame>
    <description>Identify specific education topics that women would like to receive as part of their lifestyle intervention.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Menopause</condition>
  <condition>Menopause Related Conditions</condition>
  <arm_group>
    <arm_group_label>High SES / African-American Women</arm_group_label>
    <description>Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of higher socioeconomic status (SES) and will be African-American/Black.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High SES / Caucasian Women</arm_group_label>
    <description>Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of higher socioeconomic status (SES) and will be Caucasian/White.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low SES / African-American Women</arm_group_label>
    <description>Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of lower socioeconomic status (SES) and will be African-American/Black.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low SES / Caucasian Women</arm_group_label>
    <description>Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of lower socioeconomic status (SES) and will be Caucasian/White.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Focus Groups</intervention_name>
    <description>The investigators are enrolling up to 56 women (total) to participate in semi-structured focus groups of 6-8 women per group conducted either in-person or virtually (online) to help us tailor a lifestyle intervention for midlife women during perimenopause.</description>
    <arm_group_label>High SES / African-American Women</arm_group_label>
    <arm_group_label>High SES / Caucasian Women</arm_group_label>
    <arm_group_label>Low SES / African-American Women</arm_group_label>
    <arm_group_label>Low SES / Caucasian Women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will enroll up to 56 women who self-report having experience of menopause&#xD;
        and a desire to lose (or maintain) weight during menopause. An equal distribution of&#xD;
        African-American (AA) and Caucasian women stratified by socioeconomic status (SES) will be&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 45 to 60 years&#xD;
&#xD;
          -  Currently experiencing (or have experienced) the one of the following&#xD;
             menopause-related traits:&#xD;
&#xD;
          -  Vasomotor symptoms including hot flashes and/or night sweats&#xD;
&#xD;
          -  Irregular menstrual cycle&#xD;
&#xD;
          -  African-American (Black) or Caucasian (White) race&#xD;
&#xD;
          -  Self-report having a desire to lose (or maintain) weight during menopause&#xD;
&#xD;
          -  Willing to be recorded during the focus group for transcription purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are pre-menopausal&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Kara L Marlatt, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>November 11, 2022</last_update_submitted>
  <last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Kara Marlatt</investigator_full_name>
    <investigator_title>Assistant Professor-Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487782
org study id: PBRC 2019-056
nct id: NCT04487782
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are using a community-based participatory research (CBPR) model to develop
      a lifestyle intervention targeting weight loss that is specifically tailored to women in
      perimenopause.
This is a participatory research study which will enroll women (n of up to 56) with
      experience of menopause to help identify preferred strategies (modalities) for weight loss,
      which will combine calorie (dietary) restriction and exercise tactics.

      Aim 1: Explore attitudes and perceptions about weight gain during the menopause transition,
      and identify weight loss strategies from the patient (peer) perspective.

      - The investigators will apply these learnings: 1) to understand barriers for weight
      management during menopause; 2) to establish strategies to guide retention; 3) to finalize
      the intervention structure, including feedback on the frequency and duration of the study
      visits; and 4) to gather feedback on menopause-specific education resources set to be
      provided throughout the intervention.

      Aim 2: Engage the Community Advisory Board (CAB) of the Louisiana Clinical and Translational
      Center (LA CaTS) to understand scalability and community-based implementation of an
      intervention tailored for women in perimenopause.

      - The investigators will then utilize the Louisiana Clinical & Translational Science Center
      (LA CaTS) Community Advisory Board (CAB) to help us tailor a lifestyle intervention in
      perimenopausal women with emphasis on scalability and community-based implementation using
      learnings obtained from the focus groups.
observational model: Cohort
time perspective: Cross-Sectional
measure: Duration
time frame: 1 day
description: Identify how long would women prefer the intervention to last (e.g., number of months).
measure: Motivation
time frame: 1 day
description: Identify what motivates women (e.g., group setting, incentives, etc.).
measure: Time Commitment
time frame: 1 day
description: Identify how many times (e.g., days per week) that women would want to participate in a lifestyle intervention.
measure: Diet
time frame: 1 day
description: Identify the types of diets (e.g., keto, Mediterranean, intermittent fasting, etc.) that women have attempted before, and which diets they liked best.
measure: Exercise
time frame: 1 day
description: Identify the types of exercises (e.g., swimming, walking, weight training, etc.) that women like to do or would like to try.
measure: Location
time frame: 1 day
description: Identify where women would want to go to receive a lifestyle intervention (e.g., at Pennington, in local fitness centers, virtual/online, etc.).
measure: Barriers
time frame: 1 day
description: Identify specific barriers that women would encounter if participating in a lifestyle intervention.
measure: Menopause Education
time frame: 1 day
description: Identify specific education topics that women would like to receive as part of their lifestyle intervention.
arm group label: High SES / African-American Women
description: Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of higher socioeconomic status (SES) and will be African-American/Black.
arm group label: High SES / Caucasian Women
description: Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of higher socioeconomic status (SES) and will be Caucasian/White.
arm group label: Low SES / African-American Women
description: Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of lower socioeconomic status (SES) and will be African-American/Black.
arm group label: Low SES / Caucasian Women
description: Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of lower socioeconomic status (SES) and will be Caucasian/White.
intervention type: Other
intervention name: Focus Groups
description: The investigators are enrolling up to 56 women (total) to participate in semi-structured focus groups of 6-8 women per group conducted either in-person or virtually (online) to help us tailor a lifestyle intervention for midlife women during perimenopause.
arm group label: High SES / African-American Women
arm group label: High SES / Caucasian Women
arm group label: Low SES / African-American Women
arm group label: Low SES / Caucasian Women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 60 Years
last name: Kara L Marlatt, PhD, MPH
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Kara Marlatt
investigator title: Assistant Professor-Research
mesh term: Weight Loss
sharing ipd: Undecided