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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

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: ACT Enhanced ShipShape Behavioral: Standard ShipShape (SS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Acceptance and Commitment Therapy (ACT)-Enhanced Weight Management and Fitness Program for Navy Personnel
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.

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.

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.
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.




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029507


Contacts
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Contact: Niloofar Afari, PhD 858-642-3387 nafari@ucsd.edu
Contact: CAPT Gordon Wisbach, MD gwisbach@gmail.com

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Jennifer Webb-Murphy, PhD    619-532-5877    jennifer.a.murphy52.ctr@mail.mil   
Principal Investigator: CAPT Gordon Wisbach, MD         
Veterans Medical Research Foundation Active, not recruiting
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
San Diego Veterans Healthcare System
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Niloofar Afari, PhD Veterans Medical Research Foundation

Publications:
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Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT03029507     History of Changes
Other Study ID Numbers: H160150
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Veterans Medical Research Foundation:
Obesity
Military
Acceptance and Commitment Therapy
Overweight
Weight-management
Navy Personnel
Fitness

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms