Well-Being (Psychological Flourishing) Clinical Trial
Official title:
Purpose After Service Through Sport (PASS)
| Verified date | May 2023 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 1, 2023 |
| Est. primary completion date | March 31, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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). |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of British Columbia | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
Canada,
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* Note: There are 29 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Physical fitness | Assessed using the multistage fitness test (Leger & Lambert, 1982). There are 21 possible levels, with higher scores indicating better fitness. | Baseline (Month 0) and 6-month post PASS program commencement | |
| Other | HbA1c | A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. Higher levels of HbA1c are indicative of higher levels of circulating glucose levels. | Baseline (Month 0) and 6-month post PASS program commencement | |
| Other | Systolic and Diastolic Blood Pressure. | Assessed using a standard sphygmomanometer. Blood pressure of less than 120/80 mm Hg is considered within the normal range. Elevated blood pressure exists when readings range from 120-129 systolic and less than 80 mm Hg diastolic. Hypertension Stage 1 exists when blood pressure ranges from 130-139 systolic or 80-89 mm Hg diastolic. Hypertension Stage 2 exists when blood pressure exists at 140/90 mm Hg or higher. A Hypertensive Crisis (requires medical attention) exists if blood pressure exceeds 180/120 mm Hg. | Baseline (Month 0) and 6-month post PASS program commencement | |
| Other | C-reactive Protein (CRP) | C-reactive protein (CRP) provides an indication of inflammation in the body. Higher levels of CRP are indicative of greater inflammation. | Baseline (Month 0) and 6-month post PASS program commencement | |
| Other | Telomere Length | Telomere length provides an indication of cell aging, and is assessed using a polymerase chain reaction (PCR) test. Shorter telomeres indicate greater cell aging. | Baseline (Month 0) and 6-month post PASS program commencement | |
| Primary | 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 | Changes in life satisfaction over the course of the intervention | Life satisfaction will be assessed using the 1-item question by Fleeson (2004), with responses anchored from 0 to 10 where 0 means "the worst possible life overall" and 10 means "the best possible life overall". | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in global physical and mental health over the course of the intervention | Global indicators of physical and mental health will be assessed using items by Hays et al. (2009), each anchored on a 5-point scale (1 = "poor", 5 = "excellent") with higher scores reflecting better physical and mental health. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in stress over the course of the intervention | The 1-item Statistics Canada (2012) stress question will be used in the baseline survey and in monthly surveys to track changes in psychological stress over the study period. The SCSQ is a 1-item question, with responses anchored on a 5-point scale, with a possible scoring of 1 ("not at all stressful") to 5 ("extremely stressful"), with higher scores indicating more stress. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in anxiety over the course of the intervention | The 7-item generalized anxiety disorder scale (Spitzer et al., 2006) will be used to assess anxiety symptoms. Items are anchored on a 4-point scale (0 = "not at all" to 3 = "nearly every day") with higher scores indicative of more frequent experience of anxiety symptoms. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in post-traumatic stress disorder symptomology over the course of the intervention | The 20-item PTSD checklist for diagnostic and statistical manual of mental disorders-fifth edition (Bovin, 2016) will be used to assess PTSD symtomology. Items are anchored on a 5-point scale (1 = "not at all", 5 = "extremely") with higher scores reflective of higher levels of PTSD symptomology. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in depression over the course of the intervention | The 10-item center for epidemiologic studies depression scale by Andresen et al. (1994) will be used in the baseline survey, and will be in each monthly survey to track changes in depression symptoms over the study period. The possible range in scores is 0 to 30 depending on number of symptoms, with those symptoms weighted by frequency experienced in a week. Higher scores indicate more or more frequent symptoms. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in resilience over the course of the intervention | The brief resilience scale by Smith et al. (2008) will be used in the baseline survey, and will be in each monthly survey to track changes in resilience over the study period. This instrument uses a mean scoring system with a possible range in scores from 1-5; higher scores indicate the individual perceives they have a better ability to 'bounce back' and recover from stressful events and/or situations. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in social identification over the course of the intervention | The degree to which participants in the intervention condition identify with others in the program will be assessed using items adapted from the 4-item scale by Doosje et al. (1995). Note that this measure will only be administered to participants in the experimental (i.e., intervention) condition. Items are anchored on a 7-point scale (1 = "strongly disagree", 7 = "strongly agree") with higher scores reflecting greater social identification with the group. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in social connectedness over the course of the intervention | Social connectedness will be assessed using the 20-item social connectedness scale - revised (Lee et al., 2001). Items are anchored on a 6-point scale (1 = "strongly disagree", 6 = "strongly agree") with higher scores reflecting greater social connectedness with others. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in loneliness over the course of the intervention | Loneliness will be assessed using the 3-item loneliness scale (Hughes et al., 2004) in which items are anchored on a 3-point scale (1 = "hardly ever", 3 = "often") with higher scores reflecting greater loneliness. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in leisure-time physical activity over the course of the intervention | Leisure-time physical activity will be assessed using a modified version of the leisure score index (Courneya et al, 2004) that has been applied to Godin's leisure time exercise questionnaire (Godin & Shepard, 1985). Participants report the frequency per week and time per exercise session of any mild, moderate, or strenuous exercise that participants complete. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Change in sleep quality over the course of the intervention | Sleep quality will be assessed using the 1-item measure developed by Buysse et al. (1989), that is anchored on a 4-point scale (1 = "very bad", 4 = "very good") with higher scores reflective of better sleep. | Tracked monthly for 6 months (baseline, followed by 6 months of intervention) | |
| Secondary | Program adherence over the course of the intervention | Assessed using program logs maintained by location managers (intervention condition only). | Weekly attendance at PASS program sessions over 6 month intervention | |
| Secondary | Access and use of health services over the course of the intervention | Assessed, among intervention participants only, with a single question, "As a result of the PASS program, have you accessed support services for any of the following areas of need?", followed by an indication of which services were accessed, if any. | Assessed over 6 months (descriptive measure) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04412343 -
The Seniors COvid-19 Pandemic and Exercise Study
|
N/A |