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Table 2 Measures and Schedule of Assessments

From: Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity

Measure Description 0 m 3 m 6 m 9 m 12 m
Child and Family Characteristics
 Demographic Race and ethnicity, household income, transportation x     
 Child nutrition and activity habits; self-report (screener) FLASHE Food and Activity Screeners, Teen Version (Ages 10+) [51] x   x   x
 Parent nutrition and activity habits; self-report (screener) FLASHE Food and Activity Screeners, Parent version [51] x   x   x
 Other characteristics Parent stress [52], food insecurity [53], home food environment [54], and parental expectations for treatment [55] x     
Primary Outcome
 Child BMI Directly measured height and weight using calibrated scales x x x x x
 Child body fat percent Measured via bioelectrical impedance (Tanita, TBF 300, Arlington Heights, Ill). x x x x x
 Child Waist Circumference (cm) Standardized waist circumference measured by trained personnel, using cloth measuring tape, at level of umbilicus x x x x x
Secondary Outcomes
 Child fitness Baseline, 3-min, 4-min and 5-min heart rate after submaximal (3-min) bench-stepping test (YMCA) x   x   x
 Child physical activity; objectively tracked Garmin VivoFit 3; every week sync; day “counts” if > 10 h/d + 4/7 d/wk. Continuous
 Child blood pressure Measured with calibrated auscultatory sphygmomanometer, supine position, appropriately sized cuff [56]. x   x   x
 Fasting lipid profile Obtained as per standard protocol in Healthy Lifestyles clinic at enrollment x   x   x
 Fasting glucose Obtained as per standard protocol in Healthy Lifestyles clinic at enrollment x   x   x
 Alanine aminotransferase Obtained as per standard protocol in Healthy Lifestyles clinic at enrollment x   x   x
 Child QOL Sizing Me Up/Sizing Them Up [47] (< 10 parent/child together, 10+ child complete but with parent nearby) x   x   x
 Depression PROMIS databank x   x   x
 Anxiety PROMIS databank x   x   x
 Loneliness PROMIS databank x   x   x
 Friendship PROMIS databank x   x   x
 Parent-child relationship PROMIS databank x   x   x
 Body appreciation Body appreciation scale (13-item) x   x   x
 Parent BMI Directly measured height and weight using calibrated scales x   x   x
 Sleep duration/ quality Garmin VivoFit 3 x x x x x
Implementation Measures
 Adoption BPA usage and referrals Continuous
 Engagement Program log; number of hours of “contact” with intervention (clinic+community). Continuous
 Fidelity SOFIT Continuous
Basic Science Measures
 Research Blood Fasting serum samples x   x   
 Stool microbiome 16S rRNA gene sequencing x   x