Latinx Family Wellness

NCT05735600 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-03-17

No results posted yet for this study

Summary

Childhood is an opportune time to intervene in obesity because behaviors that are developed during this time can have long-lasting effects and disrupt trajectories of obesity. This proposal aims to test the feasibility (i.e., participant acceptance, adherence, and retention) of a family-oriented intervention "AyUDA" (Aprender y Utilizar Decisiones Apreciables-Learning and Utilizing Significant Choices). The culturally tailored, two-arm adapted intervention to engage Latinx parents in healthy feeding and lifestyle practices for their children 2-5 years old, thereby reducing early childhood overweight and obesity. The investigators will use concepts of the Social-Ecological Framework for Obesity among Latinx, and the Social Learning Theory that emphasizes the importance of observing, modeling, and imitating behaviors. This approach includes a community engagement partnership with one clinic that serves a great number of Latinx families with 2-5 aged children in Central Kentucky (General Pediatric Clinic-Clinica Amiga). The investigators propose a two-arm randomized clinical trial (RCT) randomly assigning participants to either a telehealth deep cultural level group or a culturally traditional educational group in a sample of 40 Latinx families who will be followed for six months after the intervention. Moreover, investigators will explore short-term changes of the intervention on dietary behavior changes and anthropometric measurements among family members. The feasibility study will inform effect sizes that will be used to estimate statistical power for a future R01 on Community Level Interventions to Improve Minority Health and Reduce Health Disparities, National Institute of Health (NIH).

Conditions

  • Childhood Obesity

Interventions

BEHAVIORAL

AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)

The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration.

BEHAVIORAL

AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)

The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration.

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER
  • Ana Maria Linares

    lead OTHER

Principal Investigators

  • Ana M Linares, DNS · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2024-12-28
Completion
2024-12-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735600 on ClinicalTrials.gov