Skip to main content

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