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NCT04731506

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

Terminated NA Results posted Last updated 6 February 2026
What this trial tests

NA trial testing Family Connections in Childhood Obesity in 76 participants. Terminated before completion.

Timeline
1 June 2021
Primary endpoint
28 February 2024
22 April 2025

Quick facts

Lead sponsorUniversity of Nebraska
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment76
Start date1 June 2021
Primary completion28 February 2024
Estimated completion22 April 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska

Who can join

6 and older, any sex, with Childhood Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Child- Change in BMI Z-score at 12 Months From Baseline Primary · 12 months

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 (https://www.cdc.gov/growthcharts/extended-bmi-data-files.htm). A Z-score indicates how many standard de

GroupValue95% CI
Child- Standard Care-0.158± 0.133
Child- Waitlist-0.031± 0.276
Adult- Change in BMI at 12 Months From Baseline Primary · 12 months

Adult participant's Body Mass Index (BMI), a standardized way to measure an adult's weight in relation to their height, will be determined at the initial in-person visit, then again at 12 months. Height will be measured in stocking feet with a calibrated stadiometer with a fixed vertical backboard and adjustable headboard. Weight will be measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. BMI will be calculated in kg/m2 using the established Centers for Disease Control and Prevention protocol. Higher scores mean a worse outcome. Comparisons of

GroupValue95% CI
Parent- Standard Care-0.700± 3.14
Parent- Waitlist-4.35± 12.49

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Feasibility of a culturally adapted technology-delivered, family-based childhood obesity intervention for Latino/Hispanic families in rural Nebraska: the Hispanic Family Connections study protocol.
    Brito FA, Alves TF, Santos N, Michaud TL, et al · · 2024 · cited 3× · PMID 39424377 · DOI 10.1136/bmjopen-2024-089186
  2. Relevance and Acceptability of a Technology-delivered Childhood Obesity Intervention for Hispanic/Latino Families in Rural Nebraska: A Qualitative Approach.
    Alves TF, Santos N, Squarcini C, Marta F, et al · · 2025 · cited 1× · PMID 40418743 · DOI 10.1177/21501319251338544

Verify or expand the search:

Other trials of Family Connections

Trials testing the same drug.

Other recruiting trials for Childhood Obesity

Currently open trials in the same condition.

Other University of Nebraska trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04731506.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing