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

Research output: Contribution to journalArticle

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).

Original languageEnglish (US)
Article number18
JournalBMC Obesity
Volume6
Issue number1
DOIs
StatePublished - May 6 2019

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North American Indians
Pediatric Obesity
Randomized Controlled Trials
Mothers
Obesity
Population
Postpartum Period
Pregnancy
Public Health
Maternal Behavior
Temperament
Food Supply
Family Health
Vulnerable Populations
Feeding Behavior
Ethnic Groups
Self Report
Sleep
Exercise
Psychology

Keywords

  • American Indian
  • Childhood obesity
  • Home-visiting
  • Parenting
  • Pregnancy and childbirth
  • Prevention
  • Randomized controlled trials

ASJC Scopus subject areas

  • Epidemiology
  • Endocrinology, Diabetes and Metabolism
  • Physical Therapy, Sports Therapy and Rehabilitation
  • Health Policy
  • Public Health, Environmental and Occupational Health

Cite this

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title = "Family Spirit Nurture (FSN) - A randomized controlled trial to prevent early childhood obesity in American Indian populations: Trial rationale and study protocol",
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",
author = "Allison Ingalls and Summer Rosenstock and {Foy Cuddy}, Reese and Nicole Neault and Samantha Yessilth and Novalene Goklish and Leonela Nelson and Raymond Reid and Allison Barlow",
year = "2019",
month = "5",
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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

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).

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KW - Childhood obesity

KW - Home-visiting

KW - Parenting

KW - Pregnancy and childbirth

KW - Prevention

KW - Randomized controlled trials

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