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

NCT04731506 | Terminated Results

• 2 other identifiers: 0745-20-EPP20GM104320
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (2)

• Child- Change in BMI Z-score at 12 Months From Baseline

  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 deviations a data point is from the mean. For children and adolescents, specific z-score ranges are used to define weight status: (Negative Z-score, below mean) underweight (\<-2), healthy weight (-2 to +1), (Positive Z-score, above mean) overweight (+1 to +2), and obese (\>+2). Z-scores \& Health: ≥0 greater risk for developing cardiovascular disease. \<-2 osteoporosis and bone fractures risk.

  12 months

• Adult- Change in BMI at 12 Months From Baseline

  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 scores at the time points will be made between groups to evaluate program effectiveness.

  12 months

Study Arms (2)

Standard Care

EXPERIMENTAL

Parent participants will receive an activity workbook that promotes increased physical activity, healthy diets and decreased screen time, two in-person support sessions spaced and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months. Participants in the "standard care" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents participate in intervention activities (workbook, classes, calls).

Behavioral: Family Connections

Waitlist

NO INTERVENTION

Participants randomized into the control group will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. They will be waitlisted (placed on a 6-month delayed start) to receive the full Family Connections program. Participants in the "waitlist" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents later participate in intervention activities (workbook, classes, calls).

Interventions

Family Connections BEHAVIORAL

Parent participants will receive an activity workbook that promotes increased physical activity and consumption of fruits and vegetables and decreased screen time and intake of sugary drink consumption, two in-person support sessions to help parents to develop an action plan spaced one week apart \& Interactive Voice Response (IVR) automated telephone system calls of 5 to 10 minutes that provide health education messages over 12 months (4 weekly, 4 biweekly (4), and 2 monthly). During each IVR call parents provide information on current physical activities, and food consumption that is used to provide feedback on success in subsequent IVR calls.

Standard Care

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Intervention Adult Participants
• Age ≥ 19 years
• Self-identified as Latino/Hispanic living in target counties
• Parent of a child aged 8-12 years with a BMI z-score ≥85th
• Willing and able to give informed consent
• Children Participants
• Age 6-12 years
• Body Mass Index (BMI) z-score ≥85th percentile
• Self-Identified as Latino/Hispanic living in target counties
• Assent to participate in the study

You may not qualify if:

• Contraindication to physical activity or weight loss
• Planning to move in the next 12 months
• Currently participating in weight loss program
• Pregnancy or planning to get pregnant in the next 12 months
• Not willing to be randomized
• Not willing to consent or assent to participate

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• University of Nebraska Lincoln: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Brito FA, Alves TF, Santos N, Michaud TL, Eisenhauer C, De Leon EB, Squarcini CFR, Kachman S, Almeida F, Estabrooks P. 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. BMJ Open. 2024 Oct 18;14(10):e089186. doi: 10.1136/bmjopen-2024-089186.

  PMID: 39424377 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tzeyu Michaud
• Organization: University of Nebraska Medical Center

tzeyu.michaud@unmc.edu

4028369195

Study Officials

• Tzeyu Michaud, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 1, 2021
• Study Start: June 1, 2021
• Primary Completion: February 28, 2024
• Study Completion: April 22, 2025
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Summary results (de-identified) will be shared at the completion of the study.
• Access Criteria: Request submitted to the to the Principal Investigator.

Locations

US (1)