Universal childhood obesity prevention in a rural community: Study design, methods and baseline participant characteristics of the NU-HOME randomized controlled trial.

Childhood obesity is a major health concern in the United States (US) and those living in rural communities are at higher risk than their urban counterparts. Few prevention trials have engaged whole families of school-age children in community settings, and none to date have promoted family meals, family activity and healthful home environments in rural settings through a rigorous, randomized controlled trial (RCT). The New Ulm at HOME (NU-HOME) study recruited 114 parent/child dyads in a two-arm (intervention versus wait-list control) RCT to test the efficacy of a family meals-focused program aimed to prevent excess weight gain among 7-10 year-old children in rural Minnesota. The NU-HOME program was adapted from a previously tested program for urban families through a unique community collaboration. The program included 7 monthly in-person sessions for all family members. Parents also participated in 4 motivational goal-setting phone calls. The primary outcome measures were age- and sex-adjusted child body mass index (BMI) z-score, percent body fat, and incidence of overweight and obesity post-intervention. Secondary outcomes included quality of food and beverage availability in the home, family meals and snacks; children's dietary intake quality (e.g., Healthy Eating Index (HEI)-2015, fruits and vegetables, sugar-sweetened beverages, snacks); and children's screen time and weekly minutes of moderate-to-vigorous physical activity, total physical activity, and sedentary behavior. The NU-HOME RCT was a collaborative effort of academic and health system researchers, interventionists and community leaders that aimed to prevent childhood obesity in rural communities through engagement of the whole family in an interactive intervention.