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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 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 136 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03101943
The ClinicalTrials.gov registry entry for NCT03101943 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 136 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 Control Program is the first listed.
NCT03101943 reports 0 study locations.
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.
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