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

Primary Purpose

Obesity, Overweight

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT Enhanced ShipShape
Standard ShipShape (SS)
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Military, Acceptance and Commitment Therapy, Overweight, Weight-management, Navy Personnel, Fitness

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Navy Personnel who are overweight/obese or have failed or are at risk of failing the BCA
  • 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 activities

Sites / Locations

  • Naval Medical Center San Diego
  • Veterans Medical Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT enhanced ShipShape (ACT +SS)

Standard ShipShape (SS)

Arm 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.

Standard ShipShape (SS) The standard SS-only protocol will be delivered in 8 1.5-hour weekly group psychoeducation sessions.

Outcomes

Primary Outcome Measures

Change in weight from baseline

Secondary Outcome Measures

Change in Three-Factor Eating Questionnaire (TFEQ-R18) score
Change in weight related Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R)
Change in Satisfaction with Life Scale (SWLS)

Full Information

First Posted
January 4, 2017
Last Updated
January 18, 2022
Sponsor
Veterans Medical Research Foundation
Collaborators
San Diego Veterans Healthcare System, United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03029507
Brief Title
An ACT-enhanced Weight Management and Fitness Program for Navy Personnel
Official Title
An Acceptance and Commitment Therapy (ACT)-Enhanced Weight Management and Fitness Program for Navy Personnel
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
San Diego Veterans Healthcare System, United States Naval Medical Center, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. As a result of COVID-19, this study is now being conducted virtually.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Obesity, Military, Acceptance and Commitment Therapy, Overweight, Weight-management, Navy Personnel, Fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT enhanced ShipShape (ACT +SS)
Arm Type
Experimental
Arm 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 Title
Standard ShipShape (SS)
Arm Type
Active Comparator
Arm 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(s)
ACT Enhanced ShipShape
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard ShipShape (SS)
Intervention 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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Navy Personnel who are overweight/obese or have failed or are at risk of failing the BCA 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 activities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niloofar Afari, PhD
Organizational Affiliation
Veterans Medical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Veterans Medical Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3981480
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.
Results Reference
background
PubMed Identifier
32257780
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.
Results Reference
background
PubMed Identifier
31338482
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.
Results Reference
background
PubMed Identifier
36201851
Citation
Afari N, Yarish NM, Wooldridge JS, Materna K, Hernandez J, Blanco BH, Camodeca AL, Peters JJ, Herbert MS. Lessons Learned From Transition of an In-Person to a Virtual Randomized Controlled Trial for Weight and Fitness Concerns in Active-Duty Service Members: Survey Study. J Med Internet Res. 2022 Nov 10;24(11):e37797. doi: 10.2196/37797.
Results Reference
derived

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

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