<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/NCT03236077</url>
  </required_header>
  <id_info>
    <org_study_id>1134041</org_study_id>
    <nct_id>NCT03236077</nct_id>
  </id_info>
  <brief_title>Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity</brief_title>
  <official_title>Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University at Buffalo</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>
      Despite decades of physical activity (PA) research on inactive, obese individuals, we have&#xD;
      not successfully moved the needle on exercise participation in this population. A recent&#xD;
      review aptly referred to PA recommendations among obese individuals as &quot;the public health&#xD;
      guideline that is (almost) entirely ignored&quot;[1]. While we have previously had little&#xD;
      understanding of why PA rates are so low in this population, Dr. Leone's research uncovered&#xD;
      two possible explanations: (1) women with obesity are less likely to report enjoying exercise&#xD;
      and (2) more likely than non-obese women to report exercising only when they are trying to&#xD;
      lose weight. In order to affect change among obese women, we need interventions that not only&#xD;
      address disparities in enjoyment and outcome expectations. Programs must also be practical&#xD;
      and scalable; however, these types of evidence-based programs do not exist within the context&#xD;
      that people generally exercise (e.g., community centers, gyms). We propose a novel approach&#xD;
      to increasing exercise participation in this population by focusing on exercise enjoyment,&#xD;
      increasing appreciation of the proximal benefits of PA rather than focusing on weight, and&#xD;
      addressing changes to the exercise environment that make it conducive to this population. By&#xD;
      delivering our intervention in partnership with the YMCA, we not only have the ability to&#xD;
      make changes to a typical exercise context, but we also ensure that our findings can be used&#xD;
      to help exercise-focused community organizations implement a scalable, research-tested&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot intervention study with two groups: an intervention group (targeted exercise&#xD;
      program for women with obesity and YMCA membership) and a control group (YMCA membership&#xD;
      only). The targeted exercise program will be delivered by a YMCA and will be evaluated by our&#xD;
      team. The majority of women who are recruited to this study will be randomized to receive the&#xD;
      intervention or the control condition. However, we also have a small group of women who has&#xD;
      been serving as our community advisory committee (CAC) that will also participate in the&#xD;
      intervention classes and receive the membership. They will serve as pilot testers for our&#xD;
      data collection methods and provide ongoing qualitative feedback on the intervention as part&#xD;
      of their role in the CAC.&#xD;
&#xD;
      The study will take place in two phases at two different YMCAs (Ken-Ton and Independent&#xD;
      Health) with approximately half of participants recruited for the first and the other half&#xD;
      for the second.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>YMCA attendance</measure>
    <time_frame>3 motnhs</time_frame>
    <description>YMCA attendance measured by swipes of member card</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MVPA</measure>
    <time_frame>3 months</time_frame>
    <description>Minutes/week of moderate-to-vigorous exercise measured via accelerometer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exercise Enjoyment</measure>
    <time_frame>3 months</time_frame>
    <description>Report greater enjoyment and acceptability of the exercise measured by the Physical Activity Enjoyment Scale (PACES)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fit and Fab</intervention_name>
    <description>participate in a targeted exercise program at the YMCA. Will include: Targeted exercise classes, Strength-training, Group support sessions</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Aged 18-64&#xD;
&#xD;
          -  BMI ≥ 30 (self-reported for initial screening and confirmed at informational session&#xD;
             using direct measurement)&#xD;
&#xD;
          -  Not currently participating in any regularly scheduled exercise (see definition in&#xD;
             eligibility screener)&#xD;
&#xD;
          -  Willing to come to the Ken-Ton YMCA 2-3x/week (Phase 1) or the Independent Health YMCA&#xD;
             (Phase 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Participants may not be pregnant or planning to become pregnant in the next 6 months&#xD;
&#xD;
          -  Individuals with disabilities or health conditions that render them unable to&#xD;
             participate in exercise or for whom exercise might be dangerous based on their answers&#xD;
             to the Physical Activity Readiness Questionnaire or advisement form their physician&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University at Buffalo</investigator_affiliation>
    <investigator_full_name>Lucia A Leone</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>obesity, women, exercise, physical activity,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03236077
org study id: 1134041
nct id: NCT03236077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite decades of physical activity (PA) research on inactive, obese individuals, we have
      not successfully moved the needle on exercise participation in this population. A recent
      review aptly referred to PA recommendations among obese individuals as "the public health
      guideline that is (almost) entirely ignored"[1]. While we have previously had little
      understanding of why PA rates are so low in this population, Dr. Leone's research uncovered
      two possible explanations: (1) women with obesity are less likely to report enjoying exercise
      and (2) more likely than non-obese women to report exercising only when they are trying to
      lose weight. In order to affect change among obese women, we need interventions that not only
      address disparities in enjoyment and outcome expectations. Programs must also be practical
      and scalable; however, these types of evidence-based programs do not exist within the context
      that people generally exercise (e.g., community centers, gyms). We propose a novel approach
      to increasing exercise participation in this population by focusing on exercise enjoyment,
      increasing appreciation of the proximal benefits of PA rather than focusing on weight, and
      addressing changes to the exercise environment that make it conducive to this population. By
      delivering our intervention in partnership with the YMCA, we not only have the ability to
      make changes to a typical exercise context, but we also ensure that our findings can be used
      to help exercise-focused community organizations implement a scalable, research-tested
      program.
This is a pilot intervention study with two groups: an intervention group (targeted exercise
      program for women with obesity and YMCA membership) and a control group (YMCA membership
      only). The targeted exercise program will be delivered by a YMCA and will be evaluated by our
      team. The majority of women who are recruited to this study will be randomized to receive the
      intervention or the control condition. However, we also have a small group of women who has
      been serving as our community advisory committee (CAC) that will also participate in the
      intervention classes and receive the membership. They will serve as pilot testers for our
      data collection methods and provide ongoing qualitative feedback on the intervention as part
      of their role in the CAC.

      The study will take place in two phases at two different YMCAs (Ken-Ton and Independent
      Health) with approximately half of participants recruited for the first and the other half
      for the second.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: YMCA attendance
time frame: 3 motnhs
description: YMCA attendance measured by swipes of member card
measure: MVPA
time frame: 3 months
description: Minutes/week of moderate-to-vigorous exercise measured via accelerometer
measure: Exercise Enjoyment
time frame: 3 months
description: Report greater enjoyment and acceptability of the exercise measured by the Physical Activity Enjoyment Scale (PACES)
arm group label: Control
arm group type: No Intervention
arm group label: Intervention
arm group type: Experimental
intervention type: Behavioral
intervention name: Fit and Fab
description: participate in a targeted exercise program at the YMCA. Will include: Targeted exercise classes, Strength-training, Group support sessions
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University at Buffalo
investigator full name: Lucia A Leone
investigator title: Assistant Professor
mesh term: Obesity
sharing ipd: Undecided