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NCT04731506 · ClinicalTrials.gov registry record · NA

Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities

A NA study, sponsored by University of Nebraska.

Terminated
Registry status
NA
Development phase
76
Enrollment target

NCT04731506: Clinical Trial NA study, sponsored by University of Nebraska.

NCT04731506 is a NA study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04731506, a NA study, was terminated before completion, sponsored by University of Nebraska.

TERMINATED
Registry status
NA
Development phase
76 participants
Enrollment target

Study Summary

There are marked ethnic and rural-urban disparities in the prevalence of childhood obesity (CO). Among Latino/Hispanic children, CO is almost 60% higher than that of non- Latino/Hispanic Whites, and among children in rural areas it is estimated to be 25% to almost 50% higher that of urban areas. By 2050 Latinos are expected to represent 51.2% of rural Nebraska's population, so addressing childhood obesity risk factors among Latinos/Hispanic families living in rural communities and Identifying effective interventions is an important priority. The first aim will be to collaboratively adapt all intervention materials to better fit the rural Latino/Hispanic community, including translation of materials to Spanish, inclusion of culturally relevant content and images, and use of health communication strategies to address different levels of health literacy. The second aim randomly assign enrolled participant dyads (parent and child) to either Family Connections (FC) or a waitlist standard-care (SC) group to determine preliminary effectiveness in reducing child body mass index (BMI) z-score (a standardized way to measure a child's weight in relation to their age and sex). This study will address three important questions as they apply to Latino/Hispanic in rural Nebraska: is a telephone delivered family-based childhood obesity (FBCO) program in rural Nebraska culturally relevant, usable and acceptable, is a telephone delivered FBCO program effective at reducing child BMI z-scores and what real-world factors influence the impact of the intervention to sustainably engage a meaningful population of Latino/Hispanic families who stand to benefit.

Primary Outcome

We used the mixed-effect regression model for the BMI z-score, weight, and BMI, regardless adults or kids. Weight was measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. For a child's BMI z-score, we use the formula Z=((BMI/M)\^{L}-1)/(L\\times S), where M, L, and S are parameters specific to the child's sex and age. For specific age and sex combinations, the parameters M, L, and S are obtained from reference data tables, provided by the CDC (htt

Interventions

  • BEHAVIORAL Family Connections

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2021-06-01
Est. Completion 2025-04-22
Phase NA
University of Nebraska

407 total trials

Why NCT04731506 stopped before completion

NCT04731506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Family Connections is the first listed.

NCT04731506 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04731506 about?

NCT04731506 is a clinical study titled "Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities". There are marked ethnic and rural-urban disparities in the prevalence of childhood obesity (CO). Among Latino/Hispanic children, CO is almost 60% higher than that of non- Latino/Hispanic Whites, and among children in rural areas it is estimated to be 25% to almost 50% higher that of urban areas. By ...

What is the current status of trial NCT04731506?

This trial is currently terminated. It is a NA study. The enrollment target is 76 participants. The study started on 2021-06-01. Estimated completion is 2025-04-22.

What interventions are being tested in trial NCT04731506?

The interventions under investigation include: Family Connections (BEHAVIORAL).

Who is sponsoring clinical trial NCT04731506?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04731506's enrollment target sits among peer trials

76 1062nd of 2000 higher than 932 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04731506, the US trial registry maintained by the National Library of Medicine. NCT04731506 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.