Abstract
BACKGROUND: Low-income Hispanic families face marked disparities in obesity, but interventions for obesity prevention and treatment have rarely been designed with this population as a focus. Hispanic culture is characterized by Familism, a value that prioritizes familial respect, cooperation, and togetherness. We describe the rationale and design of a trial of the Healthy Living Program (HeLP), a bilingual whole-family behavioral obesity prevention and treatment intervention designed around the value Familism and addressing food insecurity. METHODS/DESIGN: This two-group randomized comparative effectiveness trial will compare the effects of HeLP versus a primary care counseling intervention (Recommended Treatment of Obesity in Primary Care, or RTOP) on decreasing body mass index (BMI; kg/m(2)) in Hispanic children 2-16 years of age with obesity and preventing BMI increase among siblings without obesity. 164 families per arm will be recruited from primary care practices. Families randomized to HeLP will participate in 12 two-hour sessions, followed by booster sessions. HeLP sessions include family meals and instruction in parenting skills, nutrition, culinary skills, fitness, and mindfulness delivered at community recreation centers by bilingual health educators and athletic trainers. Families randomized to RTOP will be offered individual visits in primary care every 3 months throughout the 18-month follow-up period. Secondary outcomes include changes to objectively measured child fitness, the home environment related to nutrition, physical activity, and media usage, food insecurity, child eating behaviors, quality of life, parent BMI and waist circumference, and implementation outcomes. DISCUSSION: This protocol paper describes the rationale and planned methods for the comparative effectiveness trial. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT05041855 (6/13/2023).