ObesityNCT03029507
An ACT-enhanced Weight Management and Fitness Program for Navy Personnel
A study testing ACT Enhanced ShipShape and Standard ShipShape (SS) in people with Obesity and Overweight, run by Veterans Medical Research Foundation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- ACT Enhanced ShipShape and Standard ShipShape (SS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2017to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any physical limitations (injuries, pregnancy, etc.) that preclude engagement in the physical fitness activities
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Naval Medical Center San Diego
San Diego, California, 92134
Veterans Medical Research Foundation
San Diego, California, 92161
About this study
Official title: An Acceptance and Commitment Therapy (ACT)-Enhanced Weight Management and Fitness Program for Navy Personnel
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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- ACT Enhanced ShipShape, Standard ShipShape (SS)
- Keywords
- Obesity, Military, Acceptance and Commitment Therapy, Overweight, Weight-management, Navy Personnel, Fitness
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT Enhanced ShipShapeBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard ShipShape (SS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from baseline
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start8 Dec 2017
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, United States Naval Medical Center, San Diego
- Responsible party
- Sponsor
- Investigators
- Niloofar Afari, PhD, Principal investigator, Veterans Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029507
- Sponsor's protocol ID
- H160150
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2017
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3981480Dochat 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.
PubMed 32257780Afari 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.
PubMed 31338482Afari 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.
PubMed 36201851
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acceptance and Commitment Therapy (ACT)-Enhanced Weight Management and Fitness Program for Navy Personnel
- ClinicalTrials.gov ID
- NCT03029507
- Acronym / sponsor ID
- H160150
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Military, Acceptance and Commitment Therapy, Overweight, Weight-management, Navy Personnel, Fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, United States Naval Medical Center, San Diego
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT enhanced ShipShape (ACT +SS) | Experimental | Behavioral: ACT Enhanced ShipShapeThe 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) | Active comparator | Behavioral: Standard ShipShape (SS)Standard ShipShape (SS) The standard SS-only protocol will be delivered in 8 1.5-hour weekly group psychoeducation sessions. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Any physical limitations (injuries, pregnancy, etc.) that preclude engagement in the physical fitness activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT enhanced ShipShape (ACT +SS) |
| 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. | Behavioural | Standard ShipShape (SS) |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 3981480Stunkard 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.
- Background: PubMed 32257780Dochat 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.
- Background: PubMed 31338482Afari 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.
- Derived from this study: PubMed 36201851Afari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niloofar Afari, PhD principal investigator
Veterans Medical Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Enhanced ShipShape and Standard ShipShape (SS) in people with Obesity and Overweight, run by Veterans Medical Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029507, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.