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Table 1 Overview of Protocol Measures (Moms in Motion Study, Columbus, Ohio, USA)

From: Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial

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      REDCap software
Medical History, Current Health, and Health Behavior X X X (4) X X REDCap software
Delivery Outcomes X      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   X   Tanita TBF-310GS Body Composition Analyzer
Percent body fat (%) X X   X   Tanita TBF-310GS Body Composition Analyzer
Waist-hip circumference and ratio X X   X   Anthropometry performed by trained study staff
Infant health (weight and length)   X   X   Anthropometry performed by trained study staff; infant scale and infantometer
Energy expenditure and physical activity ActiGraph wGT3X-BT device X X   X   ActiLife/Centrepoint Sync software
Glycemia and Associated Biomarkers of Insulin Resistance Measures Glucose (mg/dl) In-person exam with Clinical Research Services   X   X   Blood test
Oral Glucose Tolerance Test   X   X   Blood test
Insulin (pmol/l)   X   X   Blood test
HOMA   X   X   Blood test
Hemoglobin A1c (%)   X   X   Blood test
Total cholesterol (mg/dl)   X   X   Blood test
Triglycerides (mg/dl)   X   X   Blood test
HDL-cholesterol (mg/dl)   X   X   Blood test
LDL-cholesterol (mg/dl)   X   X   Blood test
Systolic blood pressure (mmHg)   X   X   Vital sign
Diastolic blood pressure (mmHg)   X   X   Vital sign
Adiponectin (μg/ml)   X   X   Blood test
Leptin (ng/ml)   X   X   Blood test
hsCRP (mg/dl)   X   X   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   REDCap software
Diet History Questionnaire III   X   X   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   REDCap software
Perceived Stress (PSS-10) X X X (1) X   REDCap software
Process Outcome Measures Intervention acceptability, study satisfaction, suggestions for improvements Surveys    X (1) X X REDCap software
  1. Table 1 outlines the protocol measures, methodology, data sources, points of data collection, and data collection methods that will be utilized in this study