NCT03029507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

December 8, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

4.6 years

First QC Date

January 4, 2017

Last Update Submit

January 18, 2022

Conditions

ObesityOverweight

Keywords

ObesityMilitaryAcceptance and Commitment TherapyOverweightWeight-managementNavy PersonnelFitness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 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 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.

Study Arms (2)

ACT enhanced ShipShape (ACT +SS)

EXPERIMENTAL

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

Standard ShipShape (SS)

ACTIVE COMPARATOR

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

Behavioral: Standard ShipShape (SS)

Interventions

ACT Enhanced ShipShapeBEHAVIORAL

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.

ACT enhanced ShipShape (ACT +SS)
Standard ShipShape (SS)BEHAVIORAL

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.

Standard ShipShape (SS)

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Navy Personnel who are overweight/obese or have failed or are at risk of failing the BCA
  • years of age
  • Willingness to participate in the study

You may not qualify if:

  • Any physical limitations (injuries, pregnancy, etc.) that preclude engagement in the physical fitness activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Veterans Medical Research Foundation

San Diego, California, 92161, United States

Location

Related Publications (4)

  • 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.

    PMID: 3981480BACKGROUND

  • 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.

    PMID: 32257780BACKGROUND

  • 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.

    PMID: 31338482BACKGROUND

  • 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.

    PMID: 36201851DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Niloofar Afari, PhD

    Veterans Medical Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 24, 2017

Study Start

December 8, 2017

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)