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An ACT-enhanced Weight Management and Fitness Program for Navy Personnel

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ClinicalTrials.gov Identifier: NCT03029507
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
San Diego Veterans Healthcare System
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
Veterans Medical Research Foundation

Tracking Information
First Submitted Date  ICMJE January 4, 2017
First Posted Date  ICMJE January 24, 2017
Last Update Posted Date August 14, 2018
Actual Study Start Date  ICMJE December 8, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Percent 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03029507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Change in Body Fat % [ 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. ]
  • 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. ]
  • Change in Acceptance and Action Questionnaire-II (AAQ-II) 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. ]
  • Change in BCA Status by survey [ Time Frame: Outcome measures will be completed at study baseline (week 1) and 6 month follow-up post-treatment. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An ACT-enhanced Weight Management and Fitness Program for Navy Personnel
Official Title  ICMJE An Acceptance and Commitment Therapy (ACT)-Enhanced Weight Management and Fitness Program for Navy Personnel
Brief Summary 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.
Detailed Description The proposed study is a cohort-randomized controlled trial of ACT-enhanced SS (ACT+SS) compared to the standard SS-only program. Cohorts of Navy personnel (N = 280 across 28 cohorts) who are referred to the SS program due to failing or being 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 standard SS-only intervention groups. The scientific aims are to: 1) determine the effectiveness of ACT+SS compared to the standard 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 the percent 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Behavioral: ACT Enhanced ShipShape
    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.
  • Behavioral: Standard ShipShape (SS)
    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.
Study Arms  ICMJE
  • Experimental: ACT enhanced ShipShape (ACT +SS)

    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.

    Intervention: Behavioral: ACT Enhanced ShipShape
  • Active Comparator: Standard ShipShape (SS)
    Standard ShipShape (SS) The standard SS-only protocol will be delivered in 8 1.5-hour weekly group psychoeducation sessions.
    Intervention: Behavioral: Standard ShipShape (SS)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Navy Personnel eligible for ShipShape program at Naval Medical Center San Diego
  • 18-69 years of age
  • Willingness to participate in the study

Exclusion Criteria:

  • Any physical limitations (injuries, pregnancy, etc.) that preclude engagement in the physical fitness component of ShipShape
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Niloofar Afari, PhD 858-642-3387 nafari@ucsd.edu
Contact: CAPT Gordon Wisbach, MD gwisbach@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03029507
Other Study ID Numbers  ICMJE H160150
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Veterans Medical Research Foundation
Study Sponsor  ICMJE Veterans Medical Research Foundation
Collaborators  ICMJE
  • San Diego Veterans Healthcare System
  • United States Naval Medical Center, San Diego
Investigators  ICMJE
Principal Investigator: Niloofar Afari, PhD Veterans Medical Research Foundation
PRS Account Veterans Medical Research Foundation
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP