Table 1 Summary of pilot trial objectives, progression criteria, and outcomes
Objectives | Criteria for demonstrating feasibility | Evaluation outcome |
|---|---|---|
1. Demonstrate ability to recruit participants for the study | a) Achieve target enrollment of ≥ 100 participants (minimum of 25 females) for inclusion in the pilot survey study. Recruitment will require approaching < 133 service members (i.e., > 75% recruitment rate) within a 4-month recruitment period | Achieved |
b) Recruit at least 14 sample participants for inclusion in the laboratory sub-study. Recruitment will require approaching < 35 service members (i.e., > 40% recruitment rate) | Achieved | |
2. Demonstrate ability to retain participants in the study | a) Achieve post-BCT survey response rate (retention rate) of ≥ 65% | Achieved, some study modifications planned |
b) Achieve post-BCT laboratory visit retention rate of ≥ 85% | Achieved | |
3. Demonstrate the ability to collect complete study data | a) Achieve ≥ 90% complete surveys among survey responders | Partially achieved, some study modifications planned |
b) Achieve ≥ 80% completion of all lab tasks | Achieved | |
Exploratory aim | Evaluation plan | Outcome |
Explore ability to collect brief surveys during BCT | Assessment of whether it is feasible to collect BCT stressor data in real time during BCT or post-BCT only | Soldiers were unable to respond during BCT |