Effect of a Home-Visiting Intervention to Reduce Early Childhood Obesity Among Native American Children: A Randomized Clinical Trial.

Importance: Early childhood obesity disproportionately affects Native American communities. Home visiting is a promising strategy for promoting optimal infant growth in this population. Objective: To assess the impact of a brief home-visiting approach, Family Spirit Nurture (FSN), on sugar-sweetened beverage (SSB) consumption, responsive parenting and infant feeding practices, and optimal growth through 12 months post partum. Design, Setting, and Participants: This study was a 1:1 randomized clinical trial comparing FSN with an injury prevention education control condition in a reservation-based community. Participants were Navajo mothers 13 years or older with infants younger than 14 weeks recruited between March 22, 2017, and May 18, 2018, and followed up through 12 months post partum. Intent-to-treat analyses were conducted. Interventions: The 6-lesson FSN curriculum, delivered 3 to 6 months post partum by Navajo paraprofessionals, targeted optimal responsive and complementary feeding practices and avoidance of SSBs. The control group received 3 injury prevention lessons. Main Outcomes and Measures: Primary outcomes established a priori were infant SSB consumption and responsive parenting and complementary feeding practices (responsive feeding scale, age at complementary food introduction, and percentage of mothers who introduced complementary food to infants at 6 months of age or older). The secondary outcome was the effect of the intervention on infant body mass index z scores (zBMIs). Results: A total of 134 Navajo mothers of infants younger than 14 weeks were enrolled in the randomized clinical trial, including 68 (mean [SD] maternal age at enrollment, 27.4 [6.4] years) in the intervention group and 66 (mean [SD] maternal age at enrollment, 27.5 [6.1] years) in the control group. Intervention participants reported statistically significantly lower infant SSB consumption through 12 months post partum (mean [SE], 0.56 [0.12] cups per week in the intervention group and 1.78 [0.18] cups per week in the control group; incidence rate ratio, 0.31; 95% CI, 0.19-0.50). Improvements in responsive feeding practices were observed through 9 months post partum (mean [SE], 3.48 [0.07] in the intervention group and 3.22 [0.08] in the control group) (difference, 0.26; 95% CI, 0.06-0.47); statistical significance was lost at 12 months post partum. Age at which the infant was given first food was younger in the intervention group (mean [SE] age, 4.61 [0.21] months in the intervention group and 5.28 [0.23] months in the control group) (difference, -0.67; 95% CI, -0.04 to -1.29). Infants in the intervention group had lower zBMI at 6 and 9 months compared with those in the control group (mean [SE] at 9 months, 0.27 [0.14] in the intervention group and 0.81 [0.14] in the control group; difference, -0.54; 95% CI, -0.94 to -0.14). The 12-month between-group difference was meaningful but not statistically significant (mean [SE], 0.61 [0.16] in the intervention group and 1.07 [0.20] in the control group; difference, -0.46; 95% CI, -0.92 to 0.01). Conclusions and Relevance: Infants of Native American mothers who participated in a home-visiting intervention had substantially lower SSB consumption and improvements in responsive feeding practices and infant zBMI scores, suggesting the intervention is effective for promoting healthy infant feeding and growth. Trial Registration: ClinicalTrials.gov Identifier: NCT03101943.

Family Spirit Nurture (FSN) - a randomized controlled trial to prevent early childhood obesity in American Indian populations: trial rationale and study protocol.

BACKGROUND: Childhood overweight and obesity is a persistent public health issue in the US. Risk for obesity and obesity-related morbidity throughout the life course begins in utero. Native Americans suffer the greatest disparities in the US in childhood overweight and obesity status of any racial or ethnic group. Existing early childhood home-visiting interventions provide an opportunity for addressing obesity during the first 1000 days. However, to date, no evidence-based model has been specifically designed to comprehensively target early childhood obesity prevention. METHODS: This study is a randomized controlled trial to test the efficacy of home-visiting intervention, called Family Spirit Nurture, on reducing early childhood obesity in Native American children. Participants are expectant Native American mothers ages 14-24 and their child, enrolled from pregnancy to 24 months postpartum and randomized 1:1 to receive the Family Spirit Nurture intervention or a control condition. The intervention includes 36 lessons delivered one-on-one by locally-hired Native American Family Health Coaches to participating mothers from pregnancy until 18 months postpartum. A mixed methods assessment includes maternal self-reports, maternal and child observations, and physical and biological data collected at 11 time points from 32 weeks gestation to 2 years postpartum to measure the intervention's primary impact on maternal feeding behaviors; 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. DISCUSSION: None of the 20 current federally-endorsed home-visiting models have demonstrated impacts on preventing early childhood obesity. The original Family Spirit program, upon which Family Spirit Nurture is based, demonstrated effect on maternal and child behavioral health, not including obesity related risk factors. This trial has potential to inform the effectiveness of home-visiting intervention to reduce obesity risk for tribal communities and other vulnerable populations and expand public health solutions for the world's obesity crisis. TRIAL REGISTRATION: Clinicaltrials.gov (Identifier: NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months; Retrospectively registered on 07 November 2017).