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

Not Applicable

• Conditions: Obesity; Overweight
• Interventions: Behavioral: ACT Enhanced ShipShape; Behavioral: Standard ShipShape (SS)

• Registration Number: NCT03029507
• Lead Sponsor: 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. 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.

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-24
• Study Start: 2017-12-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT enhanced ShipShape (ACT +SS)	ACT Enhanced ShipShape	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)	Standard ShipShape (SS)	Standard ShipShape (SS) The standard SS-only protocol will be delivered in 8 1.5-hour weekly group psychoeducation sessions.

Primary Outcome Measures

Name	Time	Method
Change in weight from baseline	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

Name	Time	Method
Change in weight related Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R)	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	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 Satisfaction with Life Scale (SWLS)	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.

Trial Locations

Locations (2)

Veterans Medical Research Foundation; 🇺🇸 San Diego, California, United States

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States