Latinx Family Wellness

Leveraging Cultural Health Beliefs and Actions to Improve Latinx Family Wellness

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).

Study Overview

• Status: Terminated
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English); Behavioral: AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)

Detailed Description

The feasibility and effectiveness of a family-oriented intervention entitled "AyUDA" will be tested. The AyUDA intervention will provide Latinx families with culturally tailored modules to take control of modifiable behaviors and help them avoid obesogenic behaviors. This study has a longitudinal RCT study design. The study will be conducted in the University of Kentucky Friendly Clinic (Clinica Amiga). Participants will be followed for six months after the intervention. At least one adult who agrees to participate will sign the informed consent and HIPAA authorization, including the children's assent form. We anticipate that recruitment would include non-English speaking subjects due to Latinx self-identity, and for this reason, consent will be obtained in Spanish. The PIs, Co-I, and RP are fluent in English/Spanish and familiar with Latinx culture. Randomization: Randomization occurs after the baseline interview. Researchers will prepare ordered envelopes that contain the treatment assignments, one set for each stratum. Within each stratum, the treatment assignments will be placed in blocks of 10 (i.e., five assignments to each of the treatment conditions). To minimize attrition, complete contact information from participants will be collected and they will be asked to provide the phone number of two individuals who will know how to contact them in the future. Escalating incentives will be provided during data collection encounters to maximize retention. Reminders will be sent monthly for the duration of the study. Data Collection: Data will be collected by the trained RS who are blind to the study conditions at the following times: T1-baseline at recruitment-pre-intervention and randomization, T2-two weeks after the intervention, T3-Three months after the intervention, and T4-Six months after the intervention.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Clinica Amiga, UK Primary Care Pediatrics, Kentucky Clinic South
    • Lexington, Kentucky, United States, 40507
      • Polk Dalton Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Latinx family of Mexican or Central American descent
• At least one parent 18 years or older; with a child between 2-5 years old and classified as overweight or obese
• Intention to remain in Central Kentucky for at least a year after recruitment
• Access to the internet.

Exclusion Criteria:

• n/a

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual; This group will participate in weekly virtual group sessions facilitated by a culturally similar and trained health educator (Promotora). The virtual modules will be on a platform such as Zoom and will last approximately 90 minutes each. Each module will last 60 minutes with the following three components: 1) 15-minute video on behavior change-related module objective, 2) 15-minute vignette/story depicting a family implementing behavior change, and 3) 15-minute discussion on creating goals and overcoming barriers for behavior change pertaining to the module. The remaining 15-minutes will ask participants to share what worked well towards achieving goals set in the prior module	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.
Active Comparator: Traditional; This group will get the same educational materials in writing (slides with information from video, written story, and instructions on goal setting and overcoming barriers) and receive a phone call from one of the researchers each week (5 weeks in a row) to provide an opportunity to respond questions, comments, and provide guidance about following the recommendations of the written material	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scores of the Child Feeding Questionnaire	Evaluate change in scores of the Child Feeding Questionnaire (CFQ). A 31-item self-report questionnaire measuring parental beliefs, attitudes, and practices in relation to child feeding. Each item is measured using a 5-point Likert-type scale, with responses across seven factor-based domains. Scores range from 1 to 5 with higher scores indicating higher levels of each domain.	Baseline and at 1, 3, and 6 months.
Change in scores of the Caregiver's Feeding Style Questionnaire	Evaluate change in scores of the Caregiver's Feeding Style Questionnaire (CFSQ). The CFSQ is a 19-item measure which classifies caregivers into 1 of 4 feeding styles. Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.	Baseline and at 1, 3, and 6 months.
Recruitment for AyUDA	Percentage of eligible participants enrolled during the planned recruitment period.	From study start until enrollment closes up to 9 months.
Intervention completion for AyUDA.	Percentage of treatment group participants that complete all intervention sessions	From enrollment to end of intervention at 6 weeks
Retention for AyUDA.	Percentage of participants retained in the study until the conclusion	From enrollment to end of study at 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI)	Evaluation of weight (kilograms) and height (meters) to calculate BMI (kg/m^2) by age and sex following the World Health Organization (WHO) Body mass index percentile by age and sex 2-5 years.	Baseline and at 6 months after the intervention.

Collaborators and Investigators

• Sponsor: Ana Maria Linares
• Collaborators: University of Kentucky
• Investigators: Principal Investigator: Ana M Linares, DNS, University of Kentucky

Publications and helpful links

General Publications

• Williams JE, Kabukuru A, Mayo R, Griffin SF. Commentary: A social-ecological perspective on obesity among Latinos. Ethn Dis. 2011 Autumn;21(4):467-72.
• Isong IA, Rao SR, Bind MA, Avendano M, Kawachi I, Richmond TK. Racial and Ethnic Disparities in Early Childhood Obesity. Pediatrics. 2018 Jan;141(1):e20170865. doi: 10.1542/peds.2017-0865.
• Beck AL, Hoeft KS, Takayama JI, Barker JC. Beliefs and practices regarding solid food introduction among Latino parents in Northern California. Appetite. 2018 Jan 1;120:381-387. doi: 10.1016/j.appet.2017.09.023. Epub 2017 Sep 23.
• Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459. Erratum In: Pediatrics. 2018 Sep;142(3):e20181916. doi: 10.1542/peds.2018-1916.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): December 28, 2024
• Study Completion (Actual): December 28, 2024

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Childhood Obesity; Intervention; Latinx; Deep level education
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 77822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to make IPD available upon request.
• IPD Sharing Time Frame: At the end of the protocol. Approximately December 2024.
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No