Table 3.
Outcome measures and timing for the BBCS and ASCS studies
| Baseline | 4 mo | 8 mo | 12 mo | 24 mo | |
|---|---|---|---|---|---|
| PRIMARY OUTCOMES (feasibility and acceptability) | |||||
| FEASIBILITY | |||||
| Process Data: accrual of ≥80% of target within 6 months | BBCS/ASCS | - | - | - | - |
| Process Data: retention of ≥80% of study participants | - | - | - | BBCS/ASCS | BBCS |
| Safety: Absence of Serious Adverse Events Attributable to the Intervention |
Measured continuously after Baseline (BBCS/ASCS) | ||||
| ACCEPTABILITY | |||||
| Debriefing | - | - | - | BBCS/ASCS | BBCS |
| SECONDARY OUTCOMES (to evaluate magnitude and variation of change for future studies) | |||||
| PHYSICAL FUNCTIONING | |||||
| 30-second Chair Stand | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Arm Curl | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Chair Sit and Reach | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Back Scratch | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| 8-Foot Get Up and Go | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Timed 8-Foot Walk | ASCS | - | - | ASCS | - |
| Balance Testing | ASCS | - | - | ASCS | - |
| Hand Grip Strength | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| 2-Minute Step Test | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| BIOLOGICAL SAMPLES | |||||
| Blood Biomarkers | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Stool Sample | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Fingernail & Toenail Sample | BBCS/ASCS | ASCS | ASCS | BBCS/ASCS | BBCS |
| Saliva Sample | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| ANTHROPOMETRICS | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| DIETARY INTAKE | |||||
| EATS Questionnaire | ASCS | ASCS | ASCS | ASCS | - |
| Diet History Questionnaire | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| PHYSICAL ACTIVITY | |||||
| CHAMPS | ASCS | ASCS | ASCS | ASCS | - |
| Godin | BBCS/ASCS | ASCS | ASCS | BBCS/ASCS | BBCS |
| Accelerometry | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| HEALTH-RELATED QUALITY OF LIFE | |||||
| SF-36 HRQOL Index | BBCS/ASCS | ASCS | ASCS | BBCS/ASCS | BBCS |
| COMORBIDITIES | |||||
| OARS | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| PSYCHOSOCIAL | |||||
| Social Provisions Scale | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Perceived Stress Scale | BBCS/ASCS | ASCS | ASCS | BBCS/ASCS | BBCS |
| FACIT-SP | BBCS/ASCS | ASCS | ASCS | BBCS/ASCS | BBCS |
| Social Readjustment Scale | ASCS | ASCS | ASCS | ASCS | - |
| Super-Utilizer Screener | ASCS | - | - | ASCS | - |
| PSQI | ASCS | ASCS | ASCS | ASCS | - |
| Mindfulness Attention Awareness Scale | ASCS | ASCS | ASCS | ASCS | - |
| MEDIATORS/MODERATORS | |||||
| Community Support | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Self-Efficacy | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| Social Support | BBCS/ASCS | - | - | BBCS/ASCS | BBCS |
| DEMOGRAPHICS | |||||
| Participant Information | BBCS/ASCS | - | - | - | - |