Purpose After Service Through Sport (PASS)

NCT05289882 | Withdrawn DMC

• 1 other identifier: H21-02693
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of a gender-sensitized social-connectedness physical activity program in relation to key markers of well-being among military veteran men over 6 months.

Conditions

Well-Being (Psychological Flourishing)

Keywords

Mental Health; Physical Health; Military Veterans; Social Connectedness; Men's Health

Outcome Measures

Primary Outcomes (1)

• Change in well-being (psychological flourishing) over the course of the intervention

  Diener's (2010) flourishing scale will be used in the baseline survey, and will be in each monthly survey to track changes in flourishing over the study period. There are 8 items, phrased in a positive direction. Scores can range from 8 (strong disagreement with all items) to 56 (strong agreement with all items), with higher scores indicating individuals who have a more positive view of themselves in important areas of functioning.

  Tracked monthly for 6 months (baseline, followed by 6 months of intervention)

Secondary Outcomes (14)

• Changes in life satisfaction over the course of the intervention

  Tracked monthly for 6 months (baseline, followed by 6 months of intervention)

• Change in global physical and mental health over the course of the intervention

  Tracked monthly for 6 months (baseline, followed by 6 months of intervention)

• Change in stress over the course of the intervention

  Tracked monthly for 6 months (baseline, followed by 6 months of intervention)

• Change in anxiety over the course of the intervention

  Tracked monthly for 6 months (baseline, followed by 6 months of intervention)

• Change in post-traumatic stress disorder symptomology over the course of the intervention

  Tracked monthly for 6 months (baseline, followed by 6 months of intervention)

Other Outcomes (5)

• Physical fitness

  Baseline (Month 0) and 6-month post PASS program commencement

• HbA1c

  Baseline (Month 0) and 6-month post PASS program commencement

• Systolic and Diastolic Blood Pressure.

  Baseline (Month 0) and 6-month post PASS program commencement

Study Arms (2)

PASS Program Condition

EXPERIMENTAL

Participants in this condition will take part in weekly physical activity, augmented with built-in opportunities to socially connect, and be directed to veteran-specific support services and resources.

Behavioral: PASS Program Condition:

Waitlist Control

NO INTERVENTION

Those randomized to the wait-list control condition will go about their daily lives for the duration of the 6-month assessment period (following randomization). They will be asked to complete the same measures (and will be remunerated in the same way as those in the PASS program condition, based on the completion of study measures). At the end of the 6-month trial, participants in this condition will have the opportunity to participate in the PASS program.

Interventions

PASS Program Condition: BEHAVIORAL

Participants randomized to this condition will be invited to take part in weekly ball hockey games (once per week), that will last approximately 60 minutes, and will be followed by opportunities to socially connect afterwards. The results of our feasibility study indicated that the PASS program acted as an important conduit to direct participants to other support services and resources (e.g., counseling, career transition centre, employment, education). Military veteran men are often reluctant to access such supports, especially if they attach stigma to such services (e.g., mental health services). At each site, a military veteran will be trained as a facilitator to operate as a conduit to refer participants to the relevant support services and agencies.

PASS Program Condition

Eligibility Criteria

• Gender Eligibility Details: Self-identification as a man
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Former members of the Canadian (or Allied Forces; e.g., NATO countries) military, or current members of the Canadian military, and not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity.
• Self-identification as a man (if sex at birth is 'female' but participants identify as 'man' they are eligible to participate).
• Have received full dosage of the COVID-19 vaccination (min 2 injections) and must provide proof of vaccination, as this is required to access all active military bases in Canada.
• Be able to read and understand English or French.
• Have access to a computer, tablet, or other device, that has access to the internet.
• Live at, or in close proximity to, one of the nine study locations (Esquimalt, BC; Edmonton, AB, Shilo, MB; Borden, ON; Kingston, ON; Petawawa, ON; Valcartier, QC; Montreal, QC; Gagetown, NB)

You may not qualify if:

• Not a former member of the Canadian (or Allied Forces; e.g., NATO countries) military, or current member of the Canadian military.
• Unable to participate in moderate-intensity physical activity (as screened via the PAR-Q and ePARmedX), including a lack of ability to receive doctor's clearance for participating in physical activity.
• Unable to speak or read English or French
• Lack of internet access which prevents access to online materials (e.g., questionnaires).
• Participants do not self-identify as 'man'. If participants disclose 'sex' as female but self-identify their gender identity as 'man' they are eligible to participate in the study and we would include their psychological responses in the main analyses. In such an instance, their biological measures (blood draws, blood pressure, and physical fitness tests) would be analyzed separately from those whose sex (male) and gender identity (man) are concordant.
• Not living in proximity to one of the participating sites (in order to take part in the in-person group-based activities).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

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MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Mark R Beauchamp, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Using Optimal Design Software, and on the basis of 7 observations per participant (in psychological flourishing), 134 participants are required to detect a medium effect size of δ = .50, with Power (1 - β) set at 80%, and p \<.05 with seven time points (baseline, Months 1, 2, 3, 4, 5, and 6). To account for 9 sites across Canada (necessitating 8 dummy variables) requires an additional 80 participants. To further account for 10% attrition, a minimum of n= 238 veteran participants are needed. The study will look to recruit 252 military veterans for study participation. The study will also look to recruit N = 252 currently serving members of the Canadian Armed Forces, although it should be noted that these participants do not constitute the population of primary interest for the trial. On the basis of N = 252 military veterans and N = 252 currently serving military participants the trial will look to recruit a total of N = 504 participants.

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 22, 2022
• Study Start: September 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: June 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available from this trial 1 year after completion of the study. The data will remain available indefinitely.
• Access Criteria: The nature of the request for sharing access will be reviewed by the PI (Beauchamp, M) and the data management team. Data will be shared via secure platforms (Redcap). Contact for data access can be done through personal communication (e.g., email) with PI Beauchamp (mark.beauchamp@ubc.ca).

Locations

CA (1)