Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months

Completed · Not applicable

Conditions studied: Obesity, Infant Obesity, Mother-Child Relations, Dietary Habits, Breast Feeding, Physical Activity, Childhood Obesity, Feeding Behavior

In brief

This study aims to assess the impact of a home-visiting program, called "Family Spirit Nurture" (FSN), on reducing early childhood obesity in American Indian (AI) children. The FSN intervention targets parent feeding practices, young children's diet and physical activity (PA) and early childhood (0-2 years of age) weight status, all associated with risk for early childhood obesity and, consequently, risk for obesity over the life course. The investigators will also explore whether maternal psychosocial factors (stress, depression and substance use), household food/water security and/or constrained physical activity environments moderate FSN intervention impacts on: mother's feeding behaviors for infants and toddlers; and, children's diets, PA patterns, and weight status. Finally, the investigators will examine how maternal/infant characteristics, diet and behaviors impact the underlying biologic mechanisms of early childhood obesity and whether social and behavioral interventions can impact infant metabolic health. The investigators evaluation will employ a randomized controlled design, in which both the intervention and comparison condition receive assisted transportation to prenatal and well-baby visits (called "Optimized Standard Care"), and the comparison condition also receives potentially beneficial injury prevention education at 8 assessment visits. Primary Aims: Efficacy of Family Spirit Nurture (FSN) + Optimized Standard Care (OSC) versus Injury Prevention Education (IPE) + OSC will be assessed for each of the following from birth to 24 months postpartum: Aim 1. Mothers' implementation of recommended feeding behaviors. Hypothesis 1. FSN + OSC mothers will be more likely to meet breastfeeding and complementary feeding recommendations and engage in responsive parenting/feeding behaviors compared to IPE + OSC mothers. Aim 2. Children's consumption of healthy diet and physical activity engagement. Hypothesis 2. FSN + OSC children will consume more fruits and vegetables and fewer calories from sugar sweetened beverages (SSB), snacks and desserts, and they will have higher physical activity and reduced screen time/other sedentary activities compared to IPE + OSC children. Aim 3. Children's weight status. Hypothesis 3. Mean BMI z-scores for FSN + OSC children will be closer to zero (the mean age- and sex- specific BMI z-score for the World Health Organization standard reference population) compared to IPE + OSC children.

Key facts

Study ID

NCT03334266

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

259

Starts

2017-09-25

Expected to finish

2023-02-28

Last updated by the study team

2023-03-06

Who can join

Age: 14 and older, up to 24. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Willingness to participate
• 14 to 24 years old at the time of conception
• < 32 weeks gestation at the time of enrollment
• Reside within 1 hour (50 miles) of local Indian Health Service medical facility
• Willingness to undergo random assignment and participate in all aspects of the study

You may not qualify if…

• Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)

Where it is running

• Johns Hopkins Center for American Indian Health — Fort Defiance, Arizona, United States
• Johns Hopkins Center for American Indian Health — Whiteriver, Arizona, United States
• Johns Hopkins Center for American Indian Health — Shiprock, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.