Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Well Baby, Well Family Study
NCT06801080 · View on ClinicalTrials.gov ↗
Study Summary
BACKGROUND: The Defense Health Agency (DHA) and the Office of Military Community and Family Policy (MC\&FP) requested assistance in evaluating the effectiveness of a military pilot implementation of a civilian program designed to assist families with infants called HealthySteps (HS; HealthySteps National Office, 2018). HS is a unique pediatric primary care-based program that helps families identify and manage parenting challenges. The program interweaves the medical support of the pediatrician's office with the resources and services of a HS Specialist trained to help parents understand their infants' needs (e.g., feeding, behavior, sleep) and their role as caregivers. HS Specialists provide enhanced educational support and facilitate targeted referrals to other relevant DoD and civilian support resources. OBJECTIVE: The HS program has not been widely implemented or evaluated previously in a military context. However, a small 2-site pilot was initiated in 2017 by MC\&FP to assess the feasibility of offering the HS program in military treatment facilities (MTF). The Defense Health Agency (DHA) further determined that this pilot program could be expanded to fulfill a 2019 National Defense Authorization Act (NDAA) requirement for the implementation and evaluation of a pilot program to reduce risk factors for child abuse and neglect within the U.S. military community. APPROACH: This outcome evaluation study entailed a review of medical records for families enrolled in the HS pilot as well as the collection of prospective survey data. Survey data collected from primary caregivers enrolled in HS at seven implementation locations throughout the U.S. is being compared with survey data collected from caregivers of newborns seeking care at control locations offering pediatric treatment as usual. VALUE: The HS program is expected to improve parental engagement in well-baby care, increase targeted screenings and referrals, improve parental efficacy and knowledge, as well as
Conditions Studied
Interventions
- OTHER Treatment as Usual (TAU)
- OTHER HealthySteps (https://www.zerotothree.org/our-work/healthysteps/)
Study Locations (2)
California
- Naval Health Research Center — San Diego
Maryland
- Abt Global — Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,181 participants |
| Start Date | 2022-01-05 |
| Est. Completion | 2025-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06801080
The ClinicalTrials.gov registry entry for NCT06801080 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Naval Health Research Center, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Social Determinants of Health appearing as the primary indexed condition, and to 2 interventions — of which Treatment as Usual (TAU) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06801080 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06801080 about?
NCT06801080 is a clinical study titled "Well Baby, Well Family Study". BACKGROUND: The Defense Health Agency (DHA) and the Office of Military Community and Family Policy (MC\&FP) requested assistance in evaluating the effectiveness of a military pilot implementation of a civilian program designed to assist families with infants called HealthySteps (HS; HealthySteps Nat...
What is the current status of trial NCT06801080?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,181 participants. The study started on 2022-01-05. Estimated completion is 2025-05-31.
What conditions does trial NCT06801080 study?
This clinical trial studies the following conditions: Social Determinants of Health. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06801080?
The interventions under investigation include: Treatment as Usual (TAU) (OTHER), HealthySteps (https://www.zerotothree.org/our-work/healthysteps/) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06801080?
This trial is sponsored by Naval Health Research Center, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06801080 being conducted?
This trial has 2 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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