<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/NCT01693913</url>
  </required_header>
  <id_info>
    <org_study_id>YMCAAtlantaWeightLoss</org_study_id>
    <nct_id>NCT01693913</nct_id>
  </id_info>
  <brief_title>Cognitive-behavioral Weight Loss Treatment</brief_title>
  <official_title>Effects of a Cognitive-behavioral Weight Loss Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>YMCA of Metropolitan Atlanta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>YMCA of Metropolitan Atlanta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      That a treatment using a cognitive-behavioral treatment for exercise and nutrition support&#xD;
      will be associated with greater weight loss that a treatment of nutrition and exercise&#xD;
      education.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IRB approval canceled&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">April 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight</measure>
    <time_frame>baseline, months 3,6,12, 24</time_frame>
    <description>Direct measurement of weight</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Weight</condition>
  <arm_group>
    <arm_group_label>Cognitive-behavioral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nurtition education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will participate in nutrition and exercise education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive behavioral exercise and nutrition over</intervention_name>
    <arm_group_label>Cognitive-behavioral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>nutrition and exercise education</intervention_name>
    <arm_group_label>Nurtition education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Ages 21-60&#xD;
&#xD;
          -  Body mass index 30-40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Medications for a psychological disorder&#xD;
&#xD;
          -  Contraindications for exercise&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James J Annesi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>YMCA of Metro Atlanta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>YMCA of Metro Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Annesi JJ. Supported exercise improves controlled eating and weight through its effects on psychosocial factors: extending a systematic research program toward treatment development. Perm J. 2012 Winter;16(1):7-18. doi: 10.7812/11-136.</citation>
    <PMID>22529754</PMID>
  </reference>
  <reference>
    <citation>Annesi JJ, Marti CN. Path analysis of exercise treatment-induced changes in psychological factors leading to weight loss. Psychol Health. 2011 Aug;26(8):1081-98. doi: 10.1080/08870446.2010.534167. Epub 2011 Jul 25.</citation>
    <PMID>21780982</PMID>
  </reference>
  <reference>
    <citation>Annesi JJ, Unruh JL, Marti CN, Gorjala S, Tennant G. Effects of the coach approach intervention on adherence to exercise in obese women: assessing mediation of social cognitive theory factors. Res Q Exerc Sport. 2011 Mar;82(1):99-108. doi: 10.1080/02701367.2011.10599726.</citation>
    <PMID>21462690</PMID>
  </reference>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>December 27, 2013</last_update_submitted>
  <last_update_submitted_qc>December 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 31, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01693913
org study id: YMCAAtlantaWeightLoss
nct id: NCT01693913
lead sponsor: 
has dmc: No
That a treatment using a cognitive-behavioral treatment for exercise and nutrition support
      will be associated with greater weight loss that a treatment of nutrition and exercise
      education.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: weight
time frame: baseline, months 3,6,12, 24
description: Direct measurement of weight
arm group label: Cognitive-behavioral
arm group type: Experimental
description: Those participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks
arm group label: Nurtition education
arm group type: Active Comparator
description: This arm will participate in nutrition and exercise education
intervention type: Behavioral
intervention name: cognitive behavioral exercise and nutrition over
arm group label: Cognitive-behavioral
intervention type: Behavioral
intervention name: nutrition and exercise education
arm group label: Nurtition education
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James J Annesi, PhD
role: Principal Investigator
affiliation: YMCA of Metro Atlanta
facility: 
country: United States
citation: Annesi JJ. Supported exercise improves controlled eating and weight through its effects on psychosocial factors: extending a systematic research program toward treatment development. Perm J. 2012 Winter;16(1):7-18. doi: 10.7812/11-136.
PMID: 22529754
citation: Annesi JJ, Marti CN. Path analysis of exercise treatment-induced changes in psychological factors leading to weight loss. Psychol Health. 2011 Aug;26(8):1081-98. doi: 10.1080/08870446.2010.534167. Epub 2011 Jul 25.
PMID: 21780982
citation: Annesi JJ, Unruh JL, Marti CN, Gorjala S, Tennant G. Effects of the coach approach intervention on adherence to exercise in obese women: assessing mediation of social cognitive theory factors. Res Q Exerc Sport. 2011 Mar;82(1):99-108. doi: 10.1080/02701367.2011.10599726.
PMID: 21462690
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Weight Loss