Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 259 participants.
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
Interventions
- BEHAVIORAL Family Spirit Nurture (FSN)
- OTHER Optimized Standard Care (OSC)
- OTHER Injury Prevention Education (IPE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2023-02-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03334266
The ClinicalTrials.gov registry entry for NCT03334266 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Family Spirit Nurture (FSN) is the first listed.
NCT03334266 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.