Domains of Protocol Measures | Methodology | Data Source | Point of Data Collection | Data Collection Methods | ||||
---|---|---|---|---|---|---|---|---|
Visit 1 | Visit 2 | Check-in Calls (4) | Visit 3 | Follow-Up Call | ||||
Demographics and Medical Health Measures | Contact and sociodemographic factors (age, ethnicity, race, birthplace (country), average monthly income, government food assistance, insurance, parity, relationship status) | Surveys | X | Â | Â | Â | Â | REDCap software |
Medical History, Current Health, and Health Behavior | X | X | X (4) | X | X | REDCap software | ||
Delivery Outcomes | X | Â | Â | Â | Â | REDCap software | ||
New pregnancy | X | X | X (4) | X | X | REDCap software | ||
Body Composition and Physical Activity Measures | Weight (kg) | In-person exam with study staff | X | X | Â | X | Â | Tanita TBF-310GS Body Composition Analyzer |
Percent body fat (%) | X | X | Â | X | Â | Tanita TBF-310GS Body Composition Analyzer | ||
Waist-hip circumference and ratio | X | X | Â | X | Â | Anthropometry performed by trained study staff | ||
Infant health (weight and length) | Â | X | Â | X | Â | Anthropometry performed by trained study staff; infant scale and infantometer | ||
Energy expenditure and physical activity | ActiGraph wGT3X-BT device | X | X | Â | X | Â | ActiLife/Centrepoint Sync software | |
Glycemia and Associated Biomarkers of Insulin Resistance Measures | Glucose (mg/dl) | In-person exam with Clinical Research Services | Â | X | Â | X | Â | Blood test |
Oral Glucose Tolerance Test | Â | X | Â | X | Â | Blood test | ||
Insulin (pmol/l) | Â | X | Â | X | Â | Blood test | ||
HOMA | Â | X | Â | X | Â | Blood test | ||
Hemoglobin A1c (%) | Â | X | Â | X | Â | Blood test | ||
Total cholesterol (mg/dl) | Â | X | Â | X | Â | Blood test | ||
Triglycerides (mg/dl) | Â | X | Â | X | Â | Blood test | ||
HDL-cholesterol (mg/dl) | Â | X | Â | X | Â | Blood test | ||
LDL-cholesterol (mg/dl) | Â | X | Â | X | Â | Blood test | ||
Systolic blood pressure (mmHg) | Â | X | Â | X | Â | Vital sign | ||
Diastolic blood pressure (mmHg) | Â | X | Â | X | Â | Vital sign | ||
Adiponectin (μg/ml) |  | X |  | X |  | Blood test | ||
Leptin (ng/ml) | Â | X | Â | X | Â | Blood test | ||
hsCRP (mg/dl) | Â | X | Â | X | Â | Blood test | ||
Psychosocial Outcome Measures | Health Promoting Lifestyle Profile II | Surveys | X | X | X (1) | X | X | REDCap software |
Motivation/Confidence for Behavior Change | X | X | X (1) | X | X | REDCap software | ||
Body Shape Questionnaire | X | X | X (1) | X | Â | REDCap software | ||
Diet History Questionnaire III | Â | X | Â | X | Â | Web-based survey tool | ||
Breast/Infant Feeding | X | X | X (4) | X | X | REDCap software | ||
Pittsburgh Sleep Quality Index | X | X | X (1) | X | X | REDCap software | ||
Depression (CES-D) | X | X | X (1) | X | Â | REDCap software | ||
Perceived Stress (PSS-10) | X | X | X (1) | X | Â | REDCap software | ||
Process Outcome Measures | Intervention acceptability, study satisfaction, suggestions for improvements | Surveys | Â | Â | X (1) | X | X | REDCap software |