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NCT03101943 · ClinicalTrials.gov registry record · NA
Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
A NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- NA
- Development phase
- 136
- Enrollment target
NCT03101943: Completed NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT03101943 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 136 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03101943, a NA study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 136 participants
- Enrollment target
Study Summary
This study aims to assess the impact of a brief home-visiting module, called "Family Spirit Nurture" (FSN), on American Indian (AI) parent feeding practices associated with increased risk for early childhood obesity, with a primary focus on delaying introduction of infants' Sugar Sweetened Beverage (SSB) (including soda, energy drinks, juice with added sugar and other drinks with added sugar) intake while teaching mothers complementary feeding and responsive parenting practices. The investigators will also assess how water insecurity may moderate parents' feeding of SSBs to young children. Finally, the investigators will explore whether maternal knowledge of oral health practices and/or reduction of infants' SSB intake influences early indicators of infant's oral health (i.e., infants' oral microbiome and plaque formation). Our evaluation will employ a randomized controlled design, in which the control condition receives a beneficial home-safety educational model and assistance in safety proofing their homes for small children. Assessments in both groups will occur at baseline (between 6 and 10 weeks postpartum) and 4 months, 6 months, 9 months and 12 months postpartum. Primary Aims: Aim 1: To determine the effectiveness of the brief (6 lessons) FSN home-visiting parent feeding practice module on reducing SSB initiation and frequency among infants between 3 and 12 months of age. Hypothesis 1: Infants whose mothers receive FSN vs. controls will be less likely to introduce SSBs between 3 and 12 months of age. Aim 2: To determine the effectiveness of FSN to promote optimal complementary feeding and responsive parenting practices. Hypothesis 2: Mothers who receive FSN vs. controls will be more likely to practice recommended complementary feeding and responsive parenting practices between 3 and 12 months of age. Aim 3: To determine the impact of water insecurity on SSB consumption among infants between 3 and 6 months of age. Hypothesis 2: Parents who report water ins
Primary Outcome
To determine the effectiveness of the brief (6 lessons) FSN home-visiting parent feeding practice module on reducing SSB initiation and frequency among infants between 3 months and 12 months of age
Interventions
- OTHER Control Program
- BEHAVIORAL Family Spirit Nurture (FSN)
- OTHER Water Delivery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2019-10-18 |
| Phase | NA |
What the finished NCT03101943 record still lists
NCT03101943 is an interventional study that assigns participants to a tested intervention. The registered 136 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 (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Control Program is the first listed.
NCT03101943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03101943 about?
NCT03101943 is a clinical study titled "Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months". This study aims to assess the impact of a brief home-visiting module, called "Family Spirit Nurture" (FSN), on American Indian (AI) parent feeding practices associated with increased risk for early childhood obesity, with a primary focus on delaying introduction of infants' Sugar Sweetened Beverage ...
What is the current status of trial NCT03101943?
This trial is currently completed. It is a NA study. The enrollment target is 136 participants. The study started on 2017-03-29. Estimated completion is 2019-10-18.
What interventions are being tested in trial NCT03101943?
The interventions under investigation include: Control Program (OTHER), Family Spirit Nurture (FSN) (BEHAVIORAL), Water Delivery (OTHER).
Who is sponsoring clinical trial NCT03101943?
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
How this trial's enrollment target compares
Where NCT03101943's enrollment target sits among peer trials
136 722nd of 2000 higher than 1,275 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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