TY - JOUR
T1 - Family Spirit Nurture (FSN) - A randomized controlled trial to prevent early childhood obesity in American Indian populations
T2 - Trial rationale and study protocol
AU - Ingalls, Allison
AU - Rosenstock, Summer
AU - Foy Cuddy, Reese
AU - Neault, Nicole
AU - Yessilth, Samantha
AU - Goklish, Novalene
AU - Nelson, Leonela
AU - Reid, Raymond
AU - Barlow, Allison
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/5/6
Y1 - 2019/5/6
N2 - 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).
AB - 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).
KW - American Indian
KW - Childhood obesity
KW - Home-visiting
KW - Parenting
KW - Pregnancy and childbirth
KW - Prevention
KW - Randomized controlled trials
UR - http://www.scopus.com/inward/record.url?scp=85065332674&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85065332674&partnerID=8YFLogxK
U2 - 10.1186/s40608-019-0233-9
DO - 10.1186/s40608-019-0233-9
M3 - Article
C2 - 31080627
AN - SCOPUS:85065332674
SN - 2052-9538
VL - 6
JO - BMC Obesity
JF - BMC Obesity
IS - 1
M1 - 18
ER -