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 |