<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/NCT03029507</url>
  </required_header>
  <id_info>
    <org_study_id>H160150</org_study_id>
    <nct_id>NCT03029507</nct_id>
  </id_info>
  <brief_title>An ACT-enhanced Weight Management and Fitness Program for Navy Personnel</brief_title>
  <official_title>An Acceptance and Commitment Therapy (ACT)-Enhanced Weight Management and Fitness Program for Navy Personnel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Veterans Medical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Diego Veterans Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Veterans Medical Research Foundation</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 proposed study is a cohort-randomized controlled trial of Acceptance and Commitment&#xD;
      Therapy-enhanced ShipShape (ACT+SS) compared to the standard ShipShape-only program, for&#xD;
      overweight or obese Navy personnel. As a result of COVID-19, this study is now being&#xD;
      conducted virtually.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a cohort-randomized controlled trial of ACT-enhanced SS (ACT+SS)&#xD;
      compared to the SS-only program. Cohorts of Navy personnel who are failing or at risk of&#xD;
      failing the body composition assessment (BCA) or who are overweight/obese will be randomized&#xD;
      to receive 8 weekly ACT+SS intervention groups or 8 weekly SS-only intervention groups. The&#xD;
      scientific aims are to: 1) determine the effectiveness of ACT+SS compared to the SS-only&#xD;
      program; 2) examine psychological flexibility as a mechanism underlying intervention&#xD;
      response; and 3) explore potential moderators of intervention response. The primary outcome&#xD;
      is weight loss.&#xD;
&#xD;
      Secondary outcomes include BMI, body fat %, indices of physical activity, problem eating,&#xD;
      functioning and quality of life, emotional functioning and indices of psychological&#xD;
      flexibility, measured at baseline, mid- and post-intervention, and 3- and 6-month follow-up&#xD;
      and self- reported BCA status at 6-month follow-up. The investigators have purposefully&#xD;
      designed a cohort-randomized trial with interventions that are pragmatically implemented in a&#xD;
      real-life military setting, and outcomes that are immediately relevant to service members and&#xD;
      leadership. The cohort randomization is essential to the feasibility and acceptability of the&#xD;
      research in this setting. The military-relevant and generalizable findings are more likely to&#xD;
      have impact within the military. SS provides an ideal comparison arm that is the current&#xD;
      standard of practice in the Navy. Integrating ACT with SS in this setting overcomes many of&#xD;
      the logistical, practical, chain-of-command, and other challenges that have typically impeded&#xD;
      research in the military. The investigators have thoughtfully selected primary and secondary&#xD;
      outcomes that are theoretically linked, and additional assessments that are empirically-based&#xD;
      and will allow better understanding of mediators and moderators of intervention response in&#xD;
      Navy personnel. Due to Covid-19 we have adapted the interventions to be administered&#xD;
      virtually.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weight from baseline</measure>
    <time_frame>Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Three-Factor Eating Questionnaire (TFEQ-R18) score</measure>
    <time_frame>Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight related Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R)</measure>
    <time_frame>Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">178</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>ACT enhanced ShipShape (ACT +SS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ACT+SS intervention will be delivered in 8 1.5-hour weekly group sessions. The ACT&#xD;
+SS protocol integrates ACT concepts and strategies within the existing standard SS protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard ShipShape (SS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard ShipShape (SS) The standard SS-only protocol will be delivered in 8 1.5-hour weekly group psychoeducation sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACT Enhanced ShipShape</intervention_name>
    <description>The ACT components focus on: a) thoughts, feelings, and bodily sensations that are often present in the context of efforts to lose weight or improve fitness; b) limitations of previous efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness of experiences; and e) identification of personal values and setting and pursuing values-consistent goals in order to achieve improved quality of life.</description>
    <arm_group_label>ACT enhanced ShipShape (ACT +SS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard ShipShape (SS)</intervention_name>
    <description>The materials and format of the Standard SS-only protocol are based on recommendations from the Navy and Marine Corps Public Health Center. These include: a) education for nutrition and physical activity; b) creating and documenting goals for weight loss and physical fitness; c) a food diary to track eating habits throughout the program; d) developing behavioral strategies to initiate/maintain an exercise program; e) monitoring of physical activity (pedometer provided by the study); and f) identifying and overcoming personal triggers for over-eating.</description>
    <arm_group_label>Standard ShipShape (SS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Navy Personnel who are overweight/obese or have failed or are at risk of failing the&#xD;
             BCA&#xD;
&#xD;
          -  18-69 years of age&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any physical limitations (injuries, pregnancy, etc.) that preclude engagement in the&#xD;
             physical fitness activities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niloofar Afari, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Veterans Medical Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Medical Research Foundation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.</citation>
    <PMID>3981480</PMID>
  </reference>
  <reference>
    <citation>Dochat C, Afari N, Wooldridge JS, Herbert MS, Gasperi M, Lillis J. Confirmatory Factor Analysis of the Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R) in a United States Sample of Adults with Overweight and Obesity. J Contextual Behav Sci. 2020 Jan;15:189-196. doi: 10.1016/j.jcbs.2020.01.006. Epub 2020 Jan 10.</citation>
    <PMID>32257780</PMID>
  </reference>
  <reference>
    <citation>Afari N, Cuneo JG, Herbert M, Miller I, Webb-Murphy J, Delaney E, Peters J, Materna K, Miggantz E, Godino J, Golshan S, Wisbach G. Design for a cohort-randomized trial of an acceptance and commitment therapy-enhanced weight management and fitness program for Navy personnel. Contemp Clin Trials Commun. 2019 Jul 10;15:100408. doi: 10.1016/j.conctc.2019.100408. eCollection 2019 Sep.</citation>
    <PMID>31338482</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Military</keyword>
  <keyword>Acceptance and Commitment Therapy</keyword>
  <keyword>Overweight</keyword>
  <keyword>Weight-management</keyword>
  <keyword>Navy Personnel</keyword>
  <keyword>Fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03029507
org study id: H160150
nct id: NCT03029507
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study is a cohort-randomized controlled trial of Acceptance and Commitment
      Therapy-enhanced ShipShape (ACT+SS) compared to the standard ShipShape-only program, for
      overweight or obese Navy personnel. As a result of COVID-19, this study is now being
      conducted virtually.
The proposed study is a cohort-randomized controlled trial of ACT-enhanced SS (ACT+SS)
      compared to the SS-only program. Cohorts of Navy personnel who are failing or at risk of
      failing the body composition assessment (BCA) or who are overweight/obese will be randomized
      to receive 8 weekly ACT+SS intervention groups or 8 weekly SS-only intervention groups. The
      scientific aims are to: 1) determine the effectiveness of ACT+SS compared to the SS-only
      program; 2) examine psychological flexibility as a mechanism underlying intervention
      response; and 3) explore potential moderators of intervention response. The primary outcome
      is weight loss.

      Secondary outcomes include BMI, body fat %, indices of physical activity, problem eating,
      functioning and quality of life, emotional functioning and indices of psychological
      flexibility, measured at baseline, mid- and post-intervention, and 3- and 6-month follow-up
      and self- reported BCA status at 6-month follow-up. The investigators have purposefully
      designed a cohort-randomized trial with interventions that are pragmatically implemented in a
      real-life military setting, and outcomes that are immediately relevant to service members and
      leadership. The cohort randomization is essential to the feasibility and acceptability of the
      research in this setting. The military-relevant and generalizable findings are more likely to
      have impact within the military. SS provides an ideal comparison arm that is the current
      standard of practice in the Navy. Integrating ACT with SS in this setting overcomes many of
      the logistical, practical, chain-of-command, and other challenges that have typically impeded
      research in the military. The investigators have thoughtfully selected primary and secondary
      outcomes that are theoretically linked, and additional assessments that are empirically-based
      and will allow better understanding of mediators and moderators of intervention response in
      Navy personnel. Due to Covid-19 we have adapted the interventions to be administered
      virtually.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in weight from baseline
time frame: Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.
measure: Change in Three-Factor Eating Questionnaire (TFEQ-R18) score
time frame: Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.
measure: Change in weight related Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R)
time frame: Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.
measure: Change in Satisfaction with Life Scale (SWLS)
time frame: Outcome measures will be completed at study baseline (week 1), mid treatment ( week 4), post-treatment (week 8), and 3 and 6 month follow-up post-treatment.
arm group label: ACT enhanced ShipShape (ACT +SS)
arm group type: Experimental
description: The ACT+SS intervention will be delivered in 8 1.5-hour weekly group sessions. The ACT
+SS protocol integrates ACT concepts and strategies within the existing standard SS protocol.
arm group label: Standard ShipShape (SS)
arm group type: Active Comparator
description: Standard ShipShape (SS) The standard SS-only protocol will be delivered in 8 1.5-hour weekly group psychoeducation sessions.
intervention type: Behavioral
intervention name: ACT Enhanced ShipShape
description: The ACT components focus on: a) thoughts, feelings, and bodily sensations that are often present in the context of efforts to lose weight or improve fitness; b) limitations of previous efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness of experiences; and e) identification of personal values and setting and pursuing values-consistent goals in order to achieve improved quality of life.
arm group label: ACT enhanced ShipShape (ACT +SS)
intervention type: Behavioral
intervention name: Standard ShipShape (SS)
description: The materials and format of the Standard SS-only protocol are based on recommendations from the Navy and Marine Corps Public Health Center. These include: a) education for nutrition and physical activity; b) creating and documenting goals for weight loss and physical fitness; c) a food diary to track eating habits throughout the program; d) developing behavioral strategies to initiate/maintain an exercise program; e) monitoring of physical activity (pedometer provided by the study); and f) identifying and overcoming personal triggers for over-eating.
arm group label: Standard ShipShape (SS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Niloofar Afari, PhD
role: Principal Investigator
affiliation: Veterans Medical Research Foundation
facility: 
facility: 
country: United States
citation: Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
PMID: 3981480
citation: Dochat C, Afari N, Wooldridge JS, Herbert MS, Gasperi M, Lillis J. Confirmatory Factor Analysis of the Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R) in a United States Sample of Adults with Overweight and Obesity. J Contextual Behav Sci. 2020 Jan;15:189-196. doi: 10.1016/j.jcbs.2020.01.006. Epub 2020 Jan 10.
PMID: 32257780
citation: Afari N, Cuneo JG, Herbert M, Miller I, Webb-Murphy J, Delaney E, Peters J, Materna K, Miggantz E, Godino J, Golshan S, Wisbach G. Design for a cohort-randomized trial of an acceptance and commitment therapy-enhanced weight management and fitness program for Navy personnel. Contemp Clin Trials Commun. 2019 Jul 10;15:100408. doi: 10.1016/j.conctc.2019.100408. eCollection 2019 Sep.
PMID: 31338482
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No