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NCT03334266 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.

Completed
Registry status
NA
Development phase
259
Enrollment target

NCT03334266: Completed NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.

NCT03334266 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 259 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03334266, a NA study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.

COMPLETED
Registry status
NA
Development phase
259 participants
Enrollment target

Study Summary

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 an

Primary Outcome

Mothers will be asked questions from an adapted version of the Pre-School-Aged Beverage Intake Questionnaire (BEVQ-15) in addition to items developed by the study team and based on previous studies conducted by the co-investigators. The assessment will be used to assess feeding practices, duration of exclusive and non-exclusive breastfeeding, timing of introduction of complementary foods and types of first foods, and introduction of SSBs among infants/toddlers, including questions about the freq

Interventions

  • BEHAVIORAL Family Spirit Nurture (FSN)
  • OTHER Optimized Standard Care (OSC)
  • OTHER Injury Prevention Education (IPE)

Trial Details

FieldValue
Enrollment Target 259 participants
Start Date 2017-09-25
Est. Completion 2023-02-28
Phase NA

What the finished NCT03334266 record still lists

NCT03334266 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 3 interventions - of which Family Spirit Nurture (FSN) is the first listed.

NCT03334266 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03334266 about?

NCT03334266 is a clinical study titled "Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months". 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-...

What is the current status of trial NCT03334266?

This trial is currently completed. It is a NA study. The enrollment target is 259 participants. The study started on 2017-09-25. Estimated completion is 2023-02-28.

What interventions are being tested in trial NCT03334266?

The interventions under investigation include: Family Spirit Nurture (FSN) (BEHAVIORAL), Optimized Standard Care (OSC) (OTHER), Injury Prevention Education (IPE) (OTHER).

Who is sponsoring clinical trial NCT03334266?

This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03334266's enrollment target sits among peer trials

259 400th of 2000 higher than 1,599 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03334266, the US trial registry maintained by the National Library of Medicine. NCT03334266 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.