Ingalls 2019.

Study name	Family Spirit Nurture (FSN) – a randomized controlled trial to prevent early childhood obesity in American Indian populations: trial rationale and study protocol
Methods	Primary research questions include 1) Is the intervention effective in increasing mothers’ likelihood of meeting breastfeeding and complementary feeding recommendations? 2) Does the intervention improve responsive parenting/feeding behaviours? 3) Is the intervention effective in decreasing children’s consumption of sugar sweetened beverages, snacks and desserts, and increasing consumption of age‐appropriate fruit and vegetables?; 4) Is the intervention effective in increasing children’s physical activity levels and decreasing children’s screen time and other sedentary activities? 5) Does the intervention improve children’s BMI z‐scores? Study design: 2‐arm RCT
Participants	N = 338 expectant Native American mothers aged 14–24 who are having their first or second baby
Interventions	A home‐visiting programme called Family Spirit Nurture (FSN). The intervention includes 36 lessons delivered one‐on‐one by locally hired Native American Family Health Coaches
Outcomes	Primary outcomes: impact on maternal feeding behaviours; children’s healthy diet and physical activity; children’s weight status. Secondary measures include maternal psychosocial factors; household food and water security; infant sleep and temperament; and maternal and child metabolic status.
Starting date	25 September 2017
Contact information	aingalls@jhu.edu
Notes	NCT03334266 ‐ Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal ‐ 18 Months