Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities
NCT04731506 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2026-02-06
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
Interventions
- BEHAVIORAL
-
Family Connections
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.
Sponsors & Collaborators
-
National Institute of General Medical Sciences (NIGMS)
collaborator NIH -
University of Nebraska Lincoln
collaborator OTHER -
University of Nebraska
lead OTHER
Principal Investigators
-
Tzeyu Michaud, PhD · University of Nebraska
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-01
- Primary Completion
- 2024-02-28
- Completion
- 2025-04-22
Countries
- United States
Study Locations
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