ReintegrationPACENCT03152214
Physical Activity and Community Engagement (PACE) Among Returning Veterans
A study testing Vigorous Intensity Aerobic Exercise and Community Engagement and Community Engagement in people with Reintegration, run by Jasper A. Smits at 1 site in United States.
Trial summary
Over 2 million soldiers have deployed during the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts. While the majority of veterans reintegrate successfully following deployment, a sizable minority return and face difficulties transitioning into civilian life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reintegration
- What is being tested?
- Vigorous Intensity Aerobic Exercise and Community Engagement and Community Engagement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OEF/OIF/OND veteran
- Discharged from the US Army within/up to 12 months ago
- Endorse at least moderate difficulty with reintegration (a total score of at least 1.5 on the M2C-Q and a score of 2 on item #14)
- Use or have access to an Apple iPhone
- Has participated in less than 75 minutes of vigorous-intensity exercise per week over the last two weeks
- Understanding and willingness to comply to a 9-week study protocol
Who cannot join
- Condition or injury which would prevent exercise*
- Insufficient command of the English language
- Each veteran will complete the PAR-Q as part of the screening procedure in order to check for any condition/injury which would render exercise harmful. Each veteran will also have undergone a routine physical with medical staff prior to discharge from the U.S. Army. Thus, the veteran should have knowledge of a condition or injury which could be problematic. If such a risk is present, the veteran will be excluded from the study. Veterans will be excluded if a doctor has said that they have a heart condition and should not do physical activity or if they know of any other reason why they should not engage in physical activity. Veterans who are unsure if they are able to engage in physical activity will have to have signed approval from a physical.
Trial locations and contacts
1 site in 1 country.
About this study
Over 2 million soldiers have deployed during the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts. While the majority of veterans reintegrate successfully following deployment, a sizable minority return and face difficulties transitioning into civilian life. There is surprisingly little research on disseminable programs to facilitate reintegration, particularly outside of the formal VA healthcare system. The primary objective of this project is to develop and evaluate an integrated community- and exercise-based program that can be "prescribed" to augment existing transition assistance programs.
Read the detailed description
Founded in 2010, Team Red White and Blue (RWB) is a non-profit organization that aims to enrich the lives of veterans by enhancing their connection to their community. Initial survey findings support the mission by showing that involvement in Team RWB (1) increases connectivity; (2) helps bridge the civilian/military divide; and (3) improves well-being and life satisfaction.
Numerous trials indicate that engaging in exercise programs can improve mood and reduce symptoms of depression and anxiety (for review see Penedo and Dahn, 2005). Accordingly, prescribing a structured exercise program has the potential to facilitate involvement in RWB and a reduction in reintegration difficulties. Compared to other levels of exercise intensity, vigorous-intensity exercise has been associated with increases in well-being (Cox, Thomas, Hinton, Donahue, 2006), reductions in anxiety and depression (Balchin, Linde, Blackhurst, Rauch, \& Schönbächler, 2016; Cox, Thomas, Hinton, \& Donahue, 2004; Katula, Blissmer, \& McAuley, 1999) and improvements in quality of life (Ostman, Jewiss, \& Smart, 2016). According to the American College of Sports Medicine (ACSM), high intensity exercise methods are the leading trend in the fitness industry (Thompson, 2013). Importantly, high intensity exercise programs have gained increasing popularity particularly within military units (Haddock, Poston, Heinrich, Jahnke, \& Jitnarin, 2016).
This study aims to provide a pilot test of (1) the acceptability and effectiveness of RWB for veterans transitioning out of the military and (2) the effectiveness of a vigorous-intensity aerobic exercise prescription for enhancing the efficacy of RWB. To this end, the study will be a randomized controlled trial (RCT) that involves 75 veterans discharged from the US Army at Fort Hood who will be assigned to: 1) 8-weeks of vigorous-intensity aerobic exercise in addition to participation in a community-based program (Team RWB) or (2) 8-weeks of participation in Team RWB alone or (3) 8-weeks on a waitlist.
- Conditions
- Reintegration
- Being tested
- Vigorous Intensity Aerobic Exercise and Community Engagement, Community Engagement
- Keywords
- Transition out of military
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigorous Intensity Aerobic Exercise and Community EngagementOther
Each veteran will be provided with an Apple watch for the duration of the study. Research staff will use the resultant data to monitor the veteran's activity level. Veterans will be asked to complete three 25-minute sessions of vigorous intensity aerobic exercise per week (either running, cycling, rowing, or elliptical workouts). Data collected will include the number of minutes exercised and the heartrate level (77-85% maximum heart rate). Any exercise session of 25 minutes at > 76% of maximum heart rate will be characterized as 1 completed session of vigorous-intensity exercise. Veterans will enter the activity, minutes exercised, average heartrate, and perceived exertion into REDCap.
Community engagement will involve attending at least one Team RWB event per week through the Austin or Killeen chapters. This could be a weekly running group, hike, or community service project-among other activities. Veterans will enter whether or not they attended a Team RWB event on REDCap.
Community EngagementOther
Veterans in the study will receive a monthly calendar of Team RWB events upon assignment. Veterans will be able to participate in any Team RWB event located in Austin or Killeen. Veterans will be asked to attend at least one Team RWB event. This could be a weekly running group, hike, or community service project- among other activities. Veterans will enter whether or not they attended a Team RWB event on the REDCap exercise adherence surveys.
| Study group | Role | What they receive |
|---|---|---|
| Team RWB + Vigorous Intensity Aerobic Exercise | Experimental | Participants assigned to the integrated arm will be prescribed the following for the course of 8 weeks:
* 1 session of exercise counseling
* 3 weekly 25-minute sessions of vigorous intensity aerobic exercise
* 1 weekly Team RWB event
* 4 biweekly assessments
Participants will also complete an online assessment at week 9 to provide follow-up data. Receives: Other: Vigorous Intensity Aerobic Exercise and Community Engagement |
| Team RWB | Active comparator | Participants assigned to the Team RWB arm will be prescribed the following for the course of 8 weeks:
* 1 weekly Team RWB event
* 4 biweekly assessments
Participants will also complete an online assessment at week 9 to provide follow-up data. Receives: Other: Community Engagement |
| Waitlist | No intervention | Participants assigned to the waitlist arm will be prescribed the following for the course of 8 weeks: • 4 biweekly assessments Participants will also complete an online assessment at week 9 to provide follow-up data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Reintegration Difficulties
The Military to Civilian Questionnaire (M2C-Q) is a 16-item self-report measure of post deployment community reintegration difficulty. The M2C-Q assesses a number of theoretically related domains (e.g., overall mental health, probably PTSD, separate rating of difficulty readjusting to civilian life; Sayer et al., 2011).
Measured: 9 weeks
Secondary outcomes (5)
Acceptability of the Intervention
This will be assessed by looking at adherence to exercise or Team RWB events. The investigators will also include a measure to assess veterans' perceptions of the exercise program and of Team RWB in terms of likelihood of future engagement, program likeability, and perceived benefits of the intervention.
Measured: 9 weeks
Meaning in life
The Meaning in Life Questionnaire (MLQ) is a 10-item measure designed to measure two dimensions of meaning in life: 1) presence of meaning (how much participants feel that their lives have meaning) and 2) search for meaning (how much participants strive to find meaning in their lives).
Measured: 9 weeks
Depressive Symptoms
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure designed to screen for and monitor the severity of depressive symptoms.
Measured: 9 weeks
Life Satisfaction
The Satisfaction with Life Scale (SWLS) is a 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life (Diener, Emmons, Larsen, \& Griffin, 1985).
Measured: 9 weeks
Life Enrichment
The Team RWB Enriched Life Scale (ELS) is a 48-item instrument designed to measure an "enriched" life defined as positive health, genuine relationships, and sense of individual and shared purpose.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Sep 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReintegrationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jasper A. Smits
- Sponsor type
- University, hospital or other
- Collaborators
- Team RWB
- Responsible party
- Sponsor-investigator, Jasper A. Smits, University of Texas at Austin
- Investigators
- Scarlett O Baird, M.A., Principal investigator, University of Texas at AustinJasper A Smits, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152214
- Sponsor's protocol ID
- 2017-03-0109
- Acronym
- PACE
- Status last verified
- Dec 2019
- First submitted
- 10 May 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Community Engagement (PACE) Among Returning Veterans
- ClinicalTrials.gov ID
- NCT03152214
- Acronym / sponsor ID
- PACE / 2017-03-0109
- Conditions
- Reintegration
- Keywords
- Transition out of military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jasper A. SmitsUniversity, hospital or other
- Collaborators
- Team RWB
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 12 May 2017 (actual)
- 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.
Over 2 million soldiers have deployed during the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts. While the majority of veterans reintegrate successfully following deployment, a sizable minority return and face difficulties transitioning into civilian life. There is surprisingly little research on disseminable programs to facilitate reintegration, particularly outside of the formal VA healthcare system. The primary objective of this project is to develop and evaluate an integrated community- and exercise-based program that can be "prescribed" to augment existing transition assistance programs.
Detailed description
Founded in 2010, Team Red White and Blue (RWB) is a non-profit organization that aims to enrich the lives of veterans by enhancing their connection to their community. Initial survey findings support the mission by showing that involvement in Team RWB (1) increases connectivity; (2) helps bridge the civilian/military divide; and (3) improves well-being and life satisfaction.
Numerous trials indicate that engaging in exercise programs can improve mood and reduce symptoms of depression and anxiety (for review see Penedo and Dahn, 2005). Accordingly, prescribing a structured exercise program has the potential to facilitate involvement in RWB and a reduction in reintegration difficulties. Compared to other levels of exercise intensity, vigorous-intensity exercise has been associated with increases in well-being (Cox, Thomas, Hinton, Donahue, 2006), reductions in anxiety and depression (Balchin, Linde, Blackhurst, Rauch, \& Schönbächler, 2016; Cox, Thomas, Hinton, \& Donahue, 2004; Katula, Blissmer, \& McAuley, 1999) and improvements in quality of life (Ostman, Jewiss, \& Smart, 2016). According to the American College of Sports Medicine (ACSM), high intensity exercise methods are the leading trend in the fitness industry (Thompson, 2013). Importantly, high intensity exercise programs have gained increasing popularity particularly within military units (Haddock, Poston, Heinrich, Jahnke, \& Jitnarin, 2016).
This study aims to provide a pilot test of (1) the acceptability and effectiveness of RWB for veterans transitioning out of the military and (2) the effectiveness of a vigorous-intensity aerobic exercise prescription for enhancing the efficacy of RWB. To this end, the study will be a randomized controlled trial (RCT) that involves 75 veterans discharged from the US Army at Fort Hood who will be assigned to: 1) 8-weeks of vigorous-intensity aerobic exercise in addition to participation in a community-based program (Team RWB) or (2) 8-weeks of participation in Team RWB alone or (3) 8-weeks on a waitlist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Team RWB + Vigorous Intensity Aerobic Exercise | Experimental | Other: Vigorous Intensity Aerobic Exercise and Community EngagementParticipants assigned to the integrated arm will be prescribed the following for the course of 8 weeks: * 1 session of exercise counseling * 3 weekly 25-minute sessions of vigorous intensity aerobic exercise * 1 weekly Team RWB event * 4 biweekly assessments Participants will also complete an online assessment at week 9 to provide follow-up data. |
| Team RWB | Active comparator | Other: Community EngagementParticipants assigned to the Team RWB arm will be prescribed the following for the course of 8 weeks: * 1 weekly Team RWB event * 4 biweekly assessments Participants will also complete an online assessment at week 9 to provide follow-up data. |
| Waitlist | No intervention | –Participants assigned to the waitlist arm will be prescribed the following for the course of 8 weeks: • 4 biweekly assessments Participants will also complete an online assessment at week 9 to provide follow-up data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- OEF/OIF/OND veteran
- Discharged from the US Army within/up to 12 months ago
- Endorse at least moderate difficulty with reintegration (a total score of at least 1.5 on the M2C-Q and a score of 2 on item #14)
- Use or have access to an Apple iPhone
- Has participated in less than 75 minutes of vigorous-intensity exercise per week over the last two weeks
Key exclusion criteria (3 listed)
- Condition or injury which would prevent exercise*
- Insufficient command of the English language
- Each veteran will complete the PAR-Q as part of the screening procedure in order to check for any condition/injury which would render exercise harmful. Each veteran will also have undergone a routine physical with medical staff prior to discharge from the U.S. Army. Thus, the veteran should have knowledge of a condition or injury which could be problematic. If such a risk is present, the veteran will be excluded from the study. Veterans will be excluded if a doctor has said that they have a heart condition and should not do physical activity or if they know of any other reason why they should not engage in physical activity. Veterans who are unsure if they are able to engage in physical activity will have to have signed approval from a physical.
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 |
|---|---|---|
| Vigorous Intensity Aerobic Exercise and Community EngagementEach veteran will be provided with an Apple watch for the duration of the study. Research staff will use the resultant data to monitor the veteran's activity level. Veterans will be asked to complete three 25-minute sessions of vigorous intensity aerobic exercise per week (either running, cycling, rowing, or elliptical workouts). Data collected will include the number of minutes exercised and the heartrate level (77-85% maximum heart rate). Any exercise session of 25 minutes at > 76% of maximum heart rate will be characterized as 1 completed session of vigorous-intensity exercise. Veterans will enter the activity, minutes exercised, average heartrate, and perceived exertion into REDCap. Community engagement will involve attending at least one Team RWB event per week through the Austin or Killeen chapters. This could be a weekly running group, hike, or community service project-among other activities. Veterans will enter whether or not they attended a Team RWB event on REDCap. | Other | Team RWB + Vigorous Intensity Aerobic Exercise |
| Community EngagementVeterans in the study will receive a monthly calendar of Team RWB events upon assignment. Veterans will be able to participate in any Team RWB event located in Austin or Killeen. Veterans will be asked to attend at least one Team RWB event. This could be a weekly running group, hike, or community service project- among other activities. Veterans will enter whether or not they attended a Team RWB event on the REDCap exercise adherence surveys. | Other | Team RWB |
Primary outcome
Level of Reintegration Difficulties
Time frame: 9 weeks
The Military to Civilian Questionnaire (M2C-Q) is a 16-item self-report measure of post deployment community reintegration difficulty. The M2C-Q assesses a number of theoretically related domains (e.g., overall mental health, probably PTSD, separate rating of difficulty readjusting to civilian life; Sayer et al., 2011).
5 secondary outcomes
Acceptability of the Intervention
Time frame: 9 weeks
Meaning in life
Time frame: 9 weeks
Depressive Symptoms
Time frame: 9 weeks
Life Satisfaction
Time frame: 9 weeks
Life Enrichment
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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.
Scarlett O Baird, M.A. principal investigator
University of Texas at Austin
Jasper A Smits, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigorous Intensity Aerobic Exercise and Community Engagement and Community Engagement in people with Reintegration, run by Jasper A. Smits at 1 site 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of Reintegration Difficulties (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.