Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.
INTRODUCTION Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low resource primary care settings. METHODS Track is a 12 month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity related comorbidity. Track participants are randomized to usual primary care or to a 12 month intervention consisting of algorithm generated tailored behavior change goals, self monitoring via mobile technologies, daily self weighing using a network connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self administered surveys are collected. Follow up data will be collected from the medical record at 24months. RESULTS Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2) Participants are mainly black (54% or white (33% 12.5% are Hispanic. Participants are mostly employed and low income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression. CONCLUSIONS Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high risk patient population in need of evidence based obesity treatment.
Contemporary clinical trials