Table 2.
INVEST in Bone Health Trial Assessment Timeline
| INVEST Measurements | SV1 | SV1A | SV2 | SV3 | INT | FV1 | FV2 | INT | FV3 | FV4 |
|---|---|---|---|---|---|---|---|---|---|---|
| Participant Status | fasted | fasted | fasted | fasted | ||||||
| Weeks | −6 to 0 | 1-24 | 22-26 | 25-52 | 50-54 | |||||
| Location | WFSM or WFU | Phone | WFU | WFSM | WFSM or WFU | WFU | WFSM | WFSM or WFU | WFU | WFSM |
| Questionnaires | ||||||||||
| Phone Screener | ||||||||||
| Consent/HIP AA | • | |||||||||
| Demographics | • | |||||||||
| Medical history | • | • | ||||||||
| Medications | • | • | • | •• | • | •• | • | •• | ||
| Depression (CES-D) | • | • | •• | •• | •• | |||||
| Cognitive Assessment (MoCA) | • | • | ||||||||
| Pittsburgh Fatigability Scale | •• | •• | •• | |||||||
| PROMIS Pain Intensity and | •• | •• | •• | |||||||
| Fatigue | ||||||||||
| CHAMPS physical activity | • | • | •• | •• | •• | |||||
| Adverse Events | • | •• | •• | • | •• | •• | • | •• | ||
| Physical Exams and Physical Performance Measures | ||||||||||
| Vital signs | • | • | • | • | • | • | ||||
| Anthropometrics | • | • | • | |||||||
| eSPPB | • | • | • | |||||||
| Hand Grip Test | • | • | • | |||||||
| RMR | • | • | • | |||||||
| Activity Monitor - thigh | • | • | • | |||||||
| Activity Monitor - in vest | • | |||||||||
| 400-meter Walk – fast | • | • | • | |||||||
| TUG | • | • | • | |||||||
| Biodex | • | • | • | |||||||
| Stair climb | • | • | • | |||||||
| Musculoskeletal Assessments | ||||||||||
| DXA | • | • | • | |||||||
| QCT | • | • | • | |||||||
| D3Cr Muscle mass | • | • | • | |||||||
| Phlebotomy | ||||||||||
| CBC | • | |||||||||
| Metabolic Panel | • | |||||||||
| Vitamin D | • | |||||||||
| Plasma/Serum Storage | • | • | • | |||||||
| Other | ||||||||||
| Run-in instructions | • | • | ||||||||
| Participant Satisfaction | •• | •• | ||||||||
| Self-Efficacy | •• | •• | •• | |||||||
| Adherence monitoring | • | • | ||||||||
SV=screening visit, INT=intervention, FV=follow up visit, WFSM=Wake Forest School of Medicine, WFU=Wake Forest University, eSPPB=extended short physical performance battery, RMR=resting metabolic rate, TUG=timed up and go, DXA=dual energy x-ray absorptiometry, QCT=computed tomography, D3Cr-Deuterated creatine dilution method for directly measuring muscle mass, CBC=complete blood count. Occurrence of assessment indicated by •, collected via phone indicated by •• Phone screening will be completed prior to SV1