<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/NCT02250950</url>
  </required_header>
  <id_info>
    <org_study_id>4636</org_study_id>
    <nct_id>NCT02250950</nct_id>
  </id_info>
  <brief_title>An Examination of the Efficacy of a Self-Determination Theory and Motivational Interviewing Exercise Intervention</brief_title>
  <official_title>Decreasing Disparities in Physical Activity: An Intervention Based on Self-Determination Theory and Motivational Interviewing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Syracuse University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Syracuse University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study involves conducting an intervention based on self-determination theory&#xD;
      (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse&#xD;
      sample. It is expected that this intervention will successfully increase physical activity in&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mental and physical benefits of physical activity are well-established. However, there is&#xD;
      a racial disparity in exercise, such that minorities are much less likely to engage in&#xD;
      physical activity than are white individuals. Research suggests that a lack of motivation may&#xD;
      be an important barrier to physical activity for racial minorities. Therefore, interventions&#xD;
      which increase participants' motivation may be especially useful in promoting physical&#xD;
      activity within these groups. A previous meta-analysis has found that physical activity&#xD;
      interventions based on self-determination theory (SDT) and motivational interviewing (MI) are&#xD;
      especially effective in increasing white individuals' physical activity (Miller &amp; Gramzow,&#xD;
      under review). However, it remains unclear the extent to which these results apply to&#xD;
      minority populations. The current study involves conducting an intervention based on SDT and&#xD;
      MI to promote physical activity in a racially-diverse sample. It is expected that this&#xD;
      intervention will successfully increase physical activity in participants. Specifically, it&#xD;
      is expected that there will be a greater relative increase in physical activity in minority&#xD;
      individuals than white individuals within the intervention group because it is expected that&#xD;
      their level of activity will be lower at baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological General Well-Being Index</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic Psychological Needs in Exercise Scale</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural Regulation in Exercise Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Adherence</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Exercise Promotion</condition>
  <arm_group>
    <arm_group_label>MI and SDT Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention Condition: Participated in 12 weekly meetings led by MI- and SDT-trained exercise instructor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-MI and SDT Exercise Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control Condition: Participated in 12 weekly meetings led by an exercise instructor who was not trained in MI and SDT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MI and SDT Exercise Group</intervention_name>
    <description>The intervention group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor trained in MI and SDT. This individual will lead group discussions and will have the participants exercise together.</description>
    <arm_group_label>MI and SDT Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-MI and SDT Exercise Group</intervention_name>
    <description>This group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor who was not trained in MI and SDT. This individual will lead a regular exercise class.</description>
    <arm_group_label>Non-MI and SDT Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants were were willing to attend an exercise class once a week for 12 weeks,&#xD;
             were willing to complete questionnaires at baseline and 12 weeks, allowed the&#xD;
             intervention staff to monitor their attendance at the YMCA for 6 months post&#xD;
             intervention, and allowed the exercise instructor to create an audio recording of all&#xD;
             of the intervention sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not have any illnesses that would prevent them from exercising once a week, not be&#xD;
             pregnant or planning to get pregnant within the next 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren S Miller, M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syracuse University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lauren S. Miller</name>
      <address>
        <city>Guilderland</city>
        <state>New York</state>
        <zip>12084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>May 18, 2015</last_update_submitted>
  <last_update_submitted_qc>May 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Syracuse University</investigator_affiliation>
    <investigator_full_name>Lauren Miller</investigator_full_name>
    <investigator_title>Doctoral Candidate</investigator_title>
  </responsible_party>
  <keyword>self-determination theory</keyword>
  <keyword>motivational interviewing</keyword>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <!-- 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/NCT02250950
org study id: 4636
nct id: NCT02250950
lead sponsor: 
has dmc: Yes
The current study involves conducting an intervention based on self-determination theory
      (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse
      sample. It is expected that this intervention will successfully increase physical activity in
      participants.
The mental and physical benefits of physical activity are well-established. However, there is
      a racial disparity in exercise, such that minorities are much less likely to engage in
      physical activity than are white individuals. Research suggests that a lack of motivation may
      be an important barrier to physical activity for racial minorities. Therefore, interventions
      which increase participants' motivation may be especially useful in promoting physical
      activity within these groups. A previous meta-analysis has found that physical activity
      interventions based on self-determination theory (SDT) and motivational interviewing (MI) are
      especially effective in increasing white individuals' physical activity (Miller & Gramzow,
      under review). However, it remains unclear the extent to which these results apply to
      minority populations. The current study involves conducting an intervention based on SDT and
      MI to promote physical activity in a racially-diverse sample. It is expected that this
      intervention will successfully increase physical activity in participants. Specifically, it
      is expected that there will be a greater relative increase in physical activity in minority
      individuals than white individuals within the intervention group because it is expected that
      their level of activity will be lower at baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: International Physical Activity Questionnaire
time frame: 12 weeks
measure: Psychological General Well-Being Index
time frame: 12 weeks
measure: Basic Psychological Needs in Exercise Scale
time frame: 12 weeks
measure: Behavioural Regulation in Exercise Questionnaire
time frame: 12 weeks
measure: Physical Activity Adherence
time frame: 12 weeks
arm group label: MI and SDT Exercise Group
arm group type: Experimental
description: Intervention Condition: Participated in 12 weekly meetings led by MI- and SDT-trained exercise instructor.
arm group label: Non-MI and SDT Exercise Group
arm group type: Sham Comparator
description: Control Condition: Participated in 12 weekly meetings led by an exercise instructor who was not trained in MI and SDT.
intervention type: Behavioral
intervention name: MI and SDT Exercise Group
description: The intervention group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor trained in MI and SDT. This individual will lead group discussions and will have the participants exercise together.
arm group label: MI and SDT Exercise Group
intervention type: Behavioral
intervention name: Non-MI and SDT Exercise Group
description: This group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor who was not trained in MI and SDT. This individual will lead a regular exercise class.
arm group label: Non-MI and SDT Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lauren S Miller, M.S.
role: Principal Investigator
affiliation: Syracuse University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Syracuse University
investigator full name: Lauren Miller
investigator title: Doctoral Candidate