Study Period | ||||||
---|---|---|---|---|---|---|
Staff Member | Pre-study Screening/ Consent | Baseline | Allocation | Post-Allocation | ||
Time Point | Visit 1 | Visit 2 | Visit 3 | Retrieval | ||
RECRUITMENT/ENROLLMENT | ||||||
Eligibility Screen | Research Team Member | x | ||||
Medical Record Release and Medical Release for Exercise | Medical Provider/Arkansas Fertility and Gynecology | x | ||||
Informed Consent | Research Team Member | x | ||||
Allocation of Treatment Groups | Clinical Coordinator or PI | x | ||||
Compensation | Research Team Member | x | x | x | ||
INTERVENTION | ||||||
Diet, Exercise, Coaching* | Research Team Member | x | x1 | x1 | x | |
Standard of Care | Arkansas Fertility and Gynecology | x | x | x | x | |
ASSESSMENTS | ||||||
Demographic and Contact Information | Research Team Member | x | x | |||
Medical History | Research Team Member | x | x | |||
Vitals and Anthropometrics | Research Team Member | x | x | |||
Fasted blood collection | Phlebotomist | x | x | |||
Urine sample collection | Participant | x | x | |||
Stool sample collection | Participant | x | x | |||
Body Composition | Research Team Member | x | x | |||
Resting Energy Expenditure | Research Team Member | x | x | |||
Activity Energy Expenditure | Participant Worn Monitor | x | x | |||
Fitness Testing | Exercise Physiologist | x | x | |||
3 Day Food Records | Nutritionist | x | ||||
Coaching | Research Team Member | x1 | x1 | |||
Physical Activity Questionnaire | Participant Self-Assessment | x | x | |||
Cohen’s Perceived Stress Scale | Participant Self-Assessment | x | x | |||
Beck Depression Inventory-II | Participant Self-Assessment | x | x | |||
Oocyte and Follicular Fluid Retrieval | Arkansas Fertility and Gynecology | x | ||||
Hormonal Panel and Birth Outcomes | Arkansas Fertility and Gynecology | x | ||||
Feasibility Qualitative Interviews | Research Team Member | x1 |