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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