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

Obesity Clinical Trial

Official title:

An Acceptance and Commitment Therapy (ACT)-Enhanced Weight Management and Fitness Program for Navy Personnel

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03029507
• Other study ID #: H160150
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 8, 2017
• Est. completion date: July 2022

Study information

• Verified date: January 2022
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California
United States	Veterans Medical Research Foundation	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	San Diego Veterans Healthcare System, United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.