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Optimized Standard Care (OSC) for Parent-Child Relationship

N/A
Waitlist Available
Led By Allison Barlow, PhD
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up <32 weeks gestation-24 months postpartum
Awards & highlights

Study Summary

This trial will study whether the "Family Spirit Nurture" program can reduce early childhood obesity in American Indian children.

Eligible Conditions
  • Parent-Child Relationship
  • Breastfeeding
  • Physical Activity
  • Feeding Disorders
  • Childhood Obesity
  • Eating Habits
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~<32 weeks gestation-24 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and <32 weeks gestation-24 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time.
Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time.
Group differences in children's physical activity levels as assessed by accelerometry.
+4 more
Secondary outcome measures
Examination of how the COVID-19 pandemic impacted infant/child feeding practices, food and water security, and study participation.
Examination of whether group differences in infant metabolic health at delivery, 6, 12 months postpartum are moderated/mediated by sociodemographic, biological (pre-pregnancy BMI, etc), and psychosocial characteristics of mothers at baseline.
Explore how and why the COVID-19 pandemic impacted infant/child feeding practices, food and water security, and study participation (with a subset of 25% of participants).
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Family Spirit Nurture (FSN)Experimental Treatment2 Interventions
The intervention group (n=169) will receive the Family Spirit Nurture (FSN) + Optimized Standard Care (OSC). The FSN home-visiting module consists of 36, 60-minute lessons delivered by trained local Family Health Coaches (FHCs), from 28 weeks gestation to 18 months postpartum. Lessons focus on three key content domains: 1) promotion of optimal breastfeeding, complementary and responsive feeding across early childhood; 2) promotion of healthy infant/toddler diet and physical activity, as well as reduced screen time and sedentary lifestyle; and 3) promotion of maternal psychosocial well-being, optimization of healthy food/beverage availability and identification/creation of safe play spaces in the home environment.
Group II: Control ProgramExperimental Treatment2 Interventions
The control group will receive Injury Prevention Education (IPE) + Optimized Standard Care (OSC). The IPE home-visiting module consists of 8 30-minute lessons delivered by trained local Family Health Liaisons (FHL), from 28 weeks gestation to 18 months postpartum. The lessons will be delivered at the following assessment time points: 36 weeks gestation, 2 weeks, 2 months, 4 months, 6 months, 9 months, 12 months, and 18 months postpartum. Injury prevention lessons focus on injury prevention topics relevant to the participating communities but that will not overlap in anyway with FSN content, including: motor vehicle safety for mothers and children; preventing scald burns; fire safety; child-proofing a home; preventing falls; preventing poisonings; and preventing animal bites.
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
2,116,671 Total Patients Enrolled
Allison Barlow, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
5 Previous Clinical Trials
1,903 Total Patients Enrolled

Frequently Asked Questions

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

Would I be considered an eligible participant for this trial?

"This clinical trial is seeking 338 individuals between the ages of 14 and 24 who are currently overweight or obese. To be eligible for enrollment, candidates must reside within a 50-mile radius from an Indian Health Service clinic, have been conceived at least 14 years old, and have had < 32 weeks gestation at time of recruitment. Participants must also demonstrate their willingness to take part in all aspects of this study as well as agree to random assignment."

Answered by AI

What objectives is this medical trial attempting to fulfill?

"The primary aim of this research, evaluated over a period of 6 and 24 months post-birth, is to discern between groups in regards to the mean Body Mass Index (BMI) z-score of infants based on weight and length data gathered. Secondary goals include examining group variations regarding the correlation between maternal metabolic health at delivery and infant metabolic health as well as levels of stress experienced by mothers via the Perceived Stress Scale 4 (PSS-4). Additionally, there will be an assessment into how COVID-19 influenced feeding practices, food security & study participation."

Answered by AI

Is the research team currently looking for additional participants?

"As per the data on clinicaltrials.gov, recruitment for this trial has ended since its last edit was made on March 30th 2022. Despite no longer actively recruiting new participants, 1169 other medical studies are currently in need of volunteers."

Answered by AI

Is eligibility for this medical experiment restricted to participants of a certain age?

"This clinical trial is tailored for people aged 14 to 24. To the contrary, 297 studies exist that involve children younger than 18 and 705 trials have been created for those above 65 years old."

Answered by AI
Recent research and studies
BMC ObesityJournal
Family Spirit Nurture (FSN) – a Randomized Controlled Trial to Prevent Early Childhood Obesity in American Indian Populations: Trial Rationale and Study Protocol
Ingalls, Allison, Summer Rosenstock, Reese Foy Cuddy, Nicole Neault, Samantha Yessilth, Novalene Goklish, Leonela Nelson, Raymond Reid, and Allison Barlow. 2019. “Family Spirit Nurture (FSN) – a Randomized Controlled Trial to Prevent Early Childhood Obesity in American Indian Populations: Trial Rationale and Study Protocol”. BMC Obesity. Springer Science and Business Media LLC. doi:10.1186/s40608-019-0233-9.
clinicaltrials.govStudy
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
2017. "Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03334266.
~35 spots leftby Apr 2025
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