Family Spirit Nurture (FSN) for Relation, Mother-Child

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Johns Hopkins Center for American Indian Health, Shiprock, NM
Relation, Mother-Child+6 More
Family Spirit Nurture (FSN) - Behavioral
Eligibility
Any Age
Female
What conditions do you have?
Select

Study Summary

This trial will look at the long-term effects of the Family Spirit Nurture intervention designed to prevent early childhood obesity, as well as the impacts of the COVID-19 pandemic on early childhood sugar sweetened beverage consumption and growth. Family Spirit Nurture (FSN) is used to treat the relationship between mothers and children. The treatment can be done online. There are no placebo groups in this trial. Family Spirit Nurture (FSN) has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Relation, Mother-Child
  • Dietary Habits
  • Obesity
  • Feeding Behaviors
  • Water; Lack of

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Relation, Mother-Child

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 3 to 5 years of age

Year 5
Group differences in sugar sweetened beverage (SSB) consumption & water intake.
Year 5
Examine whether point-of-use (POU) water filters impact water security, and/or moderate intervention impact on water intake and SSB consumption.
5 years postpartum
Within study group comparison of pre-/during- COVID-19 child feeding practices, snack routines, SSB consumption and water intake and examination of associations with maternal depression and anxiety, and changes in food access.
Year 5
Group differences in children's mean BMI z-scores over time as assessed through child weight and length/height measurements through 5 years of age.
Year 5
Between study group differences, post booster lesson, in age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake.

Trial Safety

Safety Progress

1 of 3

Other trials for Relation, Mother-Child

Trial Design

1 Treatment Group

Family Spirit Nurture (FSN)
1 of 1
Experimental Treatment

110 Total Participants · 1 Treatment Group

Primary Treatment: Family Spirit Nurture (FSN) · No Placebo Group · N/A

Family Spirit Nurture (FSN)
Behavioral
Experimental Group · 1 Intervention: Family Spirit Nurture (FSN) · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family Spirit Nurture (FSN)
2017
N/A
~140

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 to 5 years of age
Closest Location: Johns Hopkins Center for American Indian Health · Shiprock, NM
Photo of new mexico 1Photo of new mexico 2Photo of new mexico 3
2005First Recorded Clinical Trial
3 TrialsResearching Relation, Mother-Child
11 CompletedClinical Trials

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
358 Previous Clinical Trials
2,057,310 Total Patients Enrolled
3 Trials studying Relation, Mother-Child
540 Patients Enrolled for Relation, Mother-Child
Allison BarlowPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

Eligibility Criteria

Age Any Age · Female Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.