Effect of personal activity trackers on weight loss in families enrolled in a comprehensive behavioral family-lifestyle intervention program in the Federally Qualified Health Center setting: a randomized controlled trial.

Background: Childhood obesity continues to be a substantial problem despite major public health efforts, and disproportionately impacts children from low-income families. Digital health tools and consumer technology offer promising opportunities for interventions, but few studies have evaluated how they might be incorporated into existing interventions or used to create new types of interventions. It remains unclear which approaches would be most beneficial for underserved pediatric populations.

Purpose: To describe the design and rationale of a single-center randomized, controlled trial evaluating the effects of personal activity tracker (PAT) use by parents on weight-status improvement in both parents and overweight children enrolled in BodyWorks (BW), a comprehensive behavioral family-lifestyle intervention program (CBFLI), in a primary-care clinic serving a predominantly low-income Latino population.

Methods: This study is being conducted in the AltaMed general pediatrics clinic at Children's Hospital Los Angeles. Eligible participants are families (child and adult caregiver) in which the child is between 7-18 years of age, has a BMI ≥85th percentile for age and sex, and has been referred to BW by their AltaMed pediatrician. BW consists of one weekly, two-hour session for 7 weeks. In a given cycle, the program is offered on two separate nights: Monday (Spanish) and Wednesday (English). Families self sort into one of two groups based on language preference. To ensure balanced allocation of language preference groups and prevent in-group cross contamination, block randomization is used to assign whole groups to either the intervention or control arms of the study. The control arm consists of usual care, while the intervention arm adds assigning a Fitbit PAT to the parents and training them in its proper use. Study personnel are blinded to group assignment during the analysis phase. Study outcomes include attendance rate, program completion rate, and changes in weight-status improvement, defined as change in weight and BMI for adults and change in BMI z-score for children. We hypothesize that the intervention arm will have better weight-related outcomes than the control arm. Study completion is anticipated in 2017, after the enrollment of approximately 150 families.

Conclusions: The study aim is to evaluate the effects of PATs on weight-related outcomes in overweight children and parents participating in a CBFLI. The results will be important for determining whether wearable devices are an effective addition to weight loss interventions for overweight and obese children.