Obesity / Overweight
Veterans Medical Research Foundation
San Diego Veterans Healthcare System
United States Naval Medical Center, San Diego
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.
- Behavioral: ACT Enhanced ShipShapeThe 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.
|Ages eligible for Study||18 Years to 69 Years|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- Navy Personnel eligible for ShipShape program at Naval Medical Center San Diego
- 18-69 years of age
- Willingness to participate in the study
- Any physical limitations (injuries, pregnancy, etc.) that preclude engagement in the physical fitness component of ShipShape
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.
United States (2)
- Naval Medical Center San Diegonot yet recruitingSan Diego, California, United States, 92134
- Veterans Medical Research Foundationnot yet recruitingSan Diego, California, United States, 92161
not yet recruiting
30 June, 2017
08 May, 2017