Table 2.
Summary of measures by aim and month
| Aim/domain | Measures | Baseline | 4 mos | 12 mos |
|---|---|---|---|---|
| Aim 1: Health effects | ||||
| Physical health | Blood tests for HbA1c (primary outcome), inflammation (hsCRP), comprehensive metabolic panel | x | x | x |
| Glucose variability (via continuous glucose monitor) | xa | xa | ||
| Body composition | Dual-energy X-ray absorptiometry (DEXA) | xa | xa | |
| PCOS symptoms | PCOS-related quality of life (PCOSQ) | x | x | x |
| Acne, hirsutism | xa | xa | ||
| PCOS-related hormones | Total testosterone, free testosterone, sex hormone-binding globulin, thyroid-stimulating hormone, follicle-stimulating hormone, luteinizing hormone, estradiol | x | x | x |
| Psychological and behavioral effects | PHQ-8, health-related quality of life (PROMIS-29), and reward-based eating | x | x | x |
| Aim 2: Potential adverse effects | ||||
| Lipids | Nuclear Magnetic Resonance lipid profile (Labcorp LipoProfile) | x | x | x |
| Diet-related symptoms | Self-report | x | x | x |
| Decreased vegetable consumption | Fruit and vegetable consumption by 24-h dietary recall | x | x | x |
| Aim 3: Assess possible moderators | ||||
| Hypothesized moderators | Insulin resistance, body mass index | x | x | x |
| Other outcomes | ||||
| Dietary adherence and changes | Self-report and 24-h dietary recall | x | x | x |
| Physical activity and sleep | Self-report | x | x | x |
| Intervention satisfaction | Self-report, optional qualitative interviews (only once per participant) | x | x | |
aAn asterisk indicates that this measure was optional or not possible for participants who were not able to attend an in-person appointment in Ann Arbor, MI