- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07608952
The Women Veteran's Health Mission
The purpose of this study is to evaluate the impact of a customized web-based e-health program to provide online health promotion (Missions), peer support, and social connectivity to women Veterans and their families.
Primary Objective
• To assess participant engagement in the program including:
completion rates (%) for each 6-12 week health program (Mission) defined as completing the assessments following the intervention number of login days among those who register and drop-out rates (%) defined as those who start but do not complete the program.
Secondary Objectives • To assess the impact of a web-based wellness program on health metrics including: change in body weight (lbs) sleep, and chronic pain (PROMIS 29 Questionnaire) stress (PROMIS Perceived Stress) social isolation (PROMIS Social Isolation Short Form 4a).
• To determine whether there is a dose-response between the number of login days into the program and changes in health metrics.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For most Canadian Armed Forces (CAF) Veterans, the transition from military to civilian life is completed successfully. In the 2016 Life After Service Survey (LASS). However, 32% reported difficulties and it appears that this proportion has been rising among those most recently released. Moreover, 28% indicated that their partners had difficulty with the release. Among veterans, an increased prevalence of chronic health problems is believed to be one of the primary reasons for challenging transitions and ongoing difficulties with civilian life. The most common health issues are chronic back problems (41%), arthritis (29%), and mental health conditions including depression (21%), Post-Traumatic Stress Disorder (PTSD) (16%), and anxiety (15%).
A recent survey comparing Veterans to Canadians from the general population demonstrated that in age and sex adjusted analyses, both male and female Veterans were significantly more likely to suffer from the above mentioned physical and mental health conditions. Chronic pain was particularly noteworthy among Veteran men (39%) and women (49%) (Hall AL, Sweet J, Tweel M, MacLean MB. BMJ Mil Health. 2022 Feb;168(1):82-87. doi: 10.1136/bmjmilitary-2020-001526. Epub 2020 Aug 30. PMID: 32868291; PMCID: PMC8788043).
Regular physical activity has been shown to be an effective treatment for all the above conditions, both alone and in combination with other therapeutic options. Yet regular physical activity is challenging for most Canadians with or without with chronic health issues.
In 2024, Women Veterans testified in a Canadian Parliamentary Hearing about the discrimination they had faced during military service. They also spoke of the ongoing challenges associated with finding timely rehabilitation services for their health problems that had arisen during their time serving. (Invisible No More. The Experiences of Canadian Women Veterans: https://www.ourcommons.ca/DocumentViewer/en/44-1/ACVA/news-release/13150242). Release from the CAF also reduces social connectivity and a sense of community as Veterans try to re-integrate into society. Providing women veterans with peer-support programs for women only, was one of the final recommendations from this Parliamentary Hearing.
The investigators therefore propose to adapt a web-based program to engage women Veterans and their families in wellness challenges (Missions) to increase participants' physical activity, improve sleep, reduce stress, eat healthy, manage weight, etc. while increasing social connectivity and peer support. Online Chat Forums, monitored daily by the investigators, will also be available to support conversations among women Veterans focusing on common health and wellness issues.
While the primary focus will be Women Veterans, participants will be able to invite male or female friends/family members to join them on the wellness Missions. The Women Chat Forums will be open only to women participants and will focus on issues initially proposed by a steering committee of women Veterans and over time by the women participating in the program.
The Women Veterans Health Mission will be based on existing web-based programs previously designed and evaluated by the investigators. The cornerstone of the program will be to engage participants to track their daily physical activity in Missions typically lasting 6 to 12 weeks while they learn and practice other healthy lifestyle habits. The website will feature evidence-based educational modules covering topics such as improving sleep, stress management, managing pain, and healthy eating/weight loss. Participants will set health goals for themselves and track their behaviours and new skills online (physical activity, sleep hygiene practices, mindful relaxation, etc.).
Participants can also form a team of friends and family members and compete against other teams if they wish. Points are awarded for daily activity tracking, learning and practicing healthy lifestyle modules and new skills, measuring health outcomes (before and after the Mission), posting comments to other team members, etc. Teams can compare their progress on a leader board where accumulated points are displayed.
The investigators have tested these programs in the workplace, among university staff, and government employees. Published results demonstrated that among 730 eligible employees, 571 (78%) participated in the online wellness program in the first year resulting in significant improvements in blood pressure, sleep quality, emotional stress, and fatigue. A significant dose response was also noted where the greatest benefits were observed among those who used the online program the most. (https://pubmed.ncbi.nlm.nih.gov/29200188/.)
The investigators launched the MissionVAV program in 2019 with funding from the Veterans and Family Wellbeing Fund. The target population for this online wellness program was Canadian Veterans, family members, and friends. During the next 6 years 1868 participants including women who self-identified as: Veterans (93), family members of Veterans (204) or friends of Veterans (37).
Building on the foundations of the MissionVAV program, we will adapt the web-based platform to respond to the needs of enrolled Women veterans and their supporters (family and friends). The investigators will use the many health modules that currently exist on the platform for problems like sedentary behaviour, excess body weight, poor sleep, elevated stress and chronic pain. The investigators will continually evaluate the website usage and the program benefits for participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Steven Grover, MD
- Phone Number: 514-791-5688
- Email: steven.grover@mcgill.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Must be:
- Canadian Woman Veteran or
- Family Member of a Canadian Women Veteran or
- Friend of a Canadian Women Veteran
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: online web-based health promotion
Online web-based health promotion program to increase physical activity.
Participants will also learn and practice other healthy lifestyle habits to improve physical and mental health.
|
Online web-based health promotion program to increase physical activity.
Participants will also learn and practice other healthy lifestyle habits to improve physical and mental health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program Completion Rates
Time Frame: Each Mission lasts 6-12 weeks
|
Program completion rates (%) for each 6-12 week health program (Mission) defined as completing the assessments at baseline and following the 6-12 week intervention
|
Each Mission lasts 6-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of the Online Wellness Missions on Body Weight
Time Frame: Each intervention lasts 6-12 weeks
|
change in body weight (lbs) between baseline and completion of the intervention
|
Each intervention lasts 6-12 weeks
|
|
Change in Sleep Quality and Chronic Pain
Time Frame: Each Mission lasts between 6 and 12 weeks
|
Change in sleep quality and chronic pain (PROMIS 29 Questionnaire) measured at baseline and following completion of the intervention (Mission)
|
Each Mission lasts between 6 and 12 weeks
|
|
Change in Stress Level
Time Frame: Each intervention lasts 6-12 weeks
|
Change in stress level (PROMIS Perceived Stress scale) between baseline and completion of intervention
|
Each intervention lasts 6-12 weeks
|
|
Change in Perceived Social Isolation
Time Frame: Each Mission lasts 6-12 weeks
|
Change in Perceived Social isolation (PROMIS Social Isolation Short Form 4a) between baseline and completion of intervention (Mission).
|
Each Mission lasts 6-12 weeks
|
|
Login Days
Time Frame: Each Mission lasts between 6 and 12 weeks.
|
Number of days that participant logs into the website between the beginning and end of each intervention (Mission).
|
Each Mission lasts between 6 and 12 weeks.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven Grover, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Women Veteran's Health
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
University Rovira i VirgiliMinisterio de Ciencia e Innovación, SpainNot yet recruitingChronic Post-operative Pain | Chronic Postsurgical Pain | Chronic Post-surgical Pain | Chronic Postoperative PainSpain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Bjorn AngKarolinska Institutet; The Swedish Research Council; Göteborg University; Forte; Dalarna...Not yet recruitingPain Management | Pain, Chronic | Chronic Pain, WidespreadSweden
-
University of FaisalabadNot yet recruiting
-
Universidade do Vale do ParaíbaCAPES Foundation - Ministry of Education, Brazil.Enrolling by invitationChronic Low Back Pain | Chronic Shoulder Pain | Chronic Knee PainBrazil
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Washington D.C. Veterans Affairs Medical CenterRecruitingChronic Back Pain | Chronic Pain (back / Neck)United States
-
Connecticut Children's Medical CenterRecruitingChronic Pain | Pain, Chronic | Chronic Pain SyndromeUnited States
-
The University of Texas Health Science Center,...RecruitingJoint Pain | Chronic Knee Pain | Chronic Pain (Back / Neck) | Chronic Pain ManagementUnited States
-
Pamukkale UniversityCompletedElderly | Pain, Chronic | Chronic Knee PainTurkey
Clinical Trials on Online Web-based Health Promotion
-
Cumhuriyet UniversityRecruitingBariatric Surgery CandidateTurkey
-
Chinese University of Hong KongCompleted
-
Marmara UniversityActive, not recruitingDiabetic Foot | Diabetes Mellitus Type 2Turkey
-
Erzincan Binali Yildirim UniversitesiAtaturk UniversityNot yet recruiting
-
Yuzuncu Yıl UniversityMarmara University; Izmir Katip Celebi University; Kocaeli University; Maltepe... and other collaboratorsNot yet recruiting
-
Cairo UniversityNot yet recruitingTemporomandibular Disorders | Smartphone Addiction
-
Arab Resource CollectiveModern University for Business and ScienceActive, not recruitingMental Health | Self Care | Performance EnhancementLebanon
-
Hitotsubashi UniversityGlobal Public Health Research FoundationCompletedBlood Pressure | Pharmacy | Cost-effectivenessBangladesh
-
Yale UniversityNational Cancer Institute (NCI)Completed
-
University of California, San FranciscoGenentech, Inc.CompletedCaregiver | Metastatic Gastrointestinal CarcinomaUnited States