Latinx Family Wellness

NCT05735600 | Terminated

• 1 other identifier: 77822
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Childhood Obesity; Latinx; Intervention; Deep level education

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Change in Body Mass Index (BMI)

  Baseline and at 6 months after the intervention.

Study Arms (2)

Virtual

EXPERIMENTAL

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)

Traditional

ACTIVE COMPARATOR

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)

Interventions

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

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.

Virtual

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

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.

Traditional

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• n/a

Sponsors & Collaborators

• Ana Maria Linares: lead
• University of Kentucky: collaborator

Study Sites (2)

Clinica Amiga, UK Primary Care Pediatrics, Kentucky Clinic South

Lexington, Kentucky, 40504, United States

Location

Polk Dalton Clinic

Lexington, Kentucky, 40507, United States

Location

Related Publications (4)

• 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.

  PMID: 22428352 BACKGROUND

• 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.

  PMID: 29483202 BACKGROUND

• 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.

  PMID: 29269386 BACKGROUND

• 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.

  PMID: 28951238 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ana M Linares, DNS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization occurs after the baseline interview. The investigators 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 for each of the treatment conditions). Participants will be informed in the assigned group without mentioning if it's the intervention or match control group. Data will be collected by the trained RS who are blind to the study conditions of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two complementary theoretical frameworks inform the proposed study. Social-Ecological Framework suggests that families are nested within multiple social contexts that can influence children's weight. At the macro level, policies can shape child obesity by supplementing families' ability to afford food (e.g., food stamps, income supports), at the messo (community) level, the built and social environments influence child obesity by providing or inhibiting access to healthy food options and safe areas to engage in physical activity. Within the family domain, family attributes, behaviors, functioning, and parental factors, directly shape child obesity. AyUDA targets the family domain by centering obesogenic (obesity-promoting) aspects and mechanisms within families. In concert with this domain, investigators draw from Social Learning Theory to account for how to influence change within the family domain by targeting parenting attitudes and behaviors.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 21, 2023
• Study Start: July 21, 2023
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: At the end of the protocol. Approximately December 2024.
• Access Criteria: Upon request

Locations

US (2)