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

Allison Ingalls, Summer Rosenstock, Reese Foy Cuddy, Nicole Neault, Samantha Yessilth, Novalene Goklish, Leonela Nelson, Raymond Reid, Allison Barlow, Allison Ingalls, Summer Rosenstock, Reese Foy Cuddy, Nicole Neault, Samantha Yessilth, Novalene Goklish, Leonela Nelson, Raymond Reid, Allison Barlow

Abstract

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).

Keywords: American Indian; Childhood obesity; Home-visiting; Parenting; Pregnancy and childbirth; Prevention; Randomized controlled trials.

Conflict of interest statement

All authors are members of a center that has a 35-year history of working with Native American communities in the Southwestern United States. This center is a part of the Johns Hopkins Bloomberg School of Public Health. Principal Investigator: Dr. Allison Barlow.This trial has received approval from the funding agencies and the following review boards: Johns Hopkins Bloomberg School of Public Health Institutional Review Board (FWA#0000287), Navajo Nation Human Research Review Board, and the Phoenix Area Indian Health Service Institutional Review Board (IRB00000643). The trial was approved by the participating tribal communities’ governing bodies. The manuscript will be reviewed and approved by the participating tribal communities’ governing bodies prior to publishing. All participants will complete written informed consent to participate; youth under age 18 will have written parent/guardian consent.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study Design and Data Collection
Fig. 2
Fig. 2
FSN Conceptual Model

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