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Family Spirit Nurture (FSN) for Obesity (PECO1-LTF Trial)

N/A
Waitlist Available
Led By Allison Barlow
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 to 5 years of age
Awards & highlights

PECO1-LTF Trial 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.

Eligible Conditions
  • Obesity
  • Dehydration
  • Childhood Obesity
  • Feeding Disorders
  • Parent-Child Relationship
  • Eating Habits

PECO1-LTF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 5 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 5 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Examine whether point-of-use (POU) water filters impact water security, and/or moderate intervention impact on water intake and SSB consumption.
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.
Group differences in sugar sweetened beverage (SSB) consumption & water intake.
Secondary outcome measures
Between study group differences, post booster lesson, in age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake.
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.

PECO1-LTF Trial Design

2Treatment groups
Experimental Treatment
Group I: Family Spirit Nurture (FSN)Experimental Treatment1 Intervention
Intervention group participants receive 1 Family Spirit Nurture lesson taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The lesson focuses on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs and promotion of water consumption. The lesson is highly visual and interactive, and incorporates cultural teachings related to child feeding and nutrition that support aims. The Family Health Coaches also provide social support and will facilitate referrals to community resources.
Group II: Control Vehicle SafetyExperimental Treatment1 Intervention
Control group participants receive 1 lesson with vehicle safety information, taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The Family Health Coaches also provide social support and will facilitate referrals to community resources.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family Spirit Nurture (FSN)
2017
N/A
~510

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,820 Total Patients Enrolled
21 Trials studying Obesity
5,489 Patients Enrolled for Obesity
Allison BarlowPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research study still ongoing?

"According to the clinicaltrials.gov website, enrollment for this medical trial has been closed since June 15th 2022 and no further participants are being accepted at this time. However, there remain over a thousand other trials actively recruiting patients right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Preventing Early Childhood Obesity, Part 1: Long-term Follow-up
2021. "Preventing Early Childhood Obesity, Part 1: Long-term Follow-up". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424471.
~28 spots leftby Apr 2025
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