Latinx Family Wellness

Childhood Obesity Clinical Trial

Official title:

Leveraging Cultural Health Beliefs and Actions to Improve Latinx Family Wellness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735600
• Other study ID #: 77822
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: University of Kentucky
• Contact: Sheila M Barnhart, PhD
• Phone: 8593237282
• Email: Sheila.Barnhart[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Clinica Amiga, UK Primary Care Pediatrics, Kentucky Clinic South	Lexington	Kentucky
United States	Polk Dalton Clinic	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Ana Maria Linares	University of Kentucky

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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): — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Recruitment for AyUDA	Percentage of eligible participants enrolled during the planned recruitment period.	From study start until enrollment closes up to 9 months.
Primary	Intervention completion for AyUDA.	Percentage of treatment group participants that complete all intervention sessions	From enrollment to end of intervention at 6 weeks
Primary	Retention for AyUDA.	Percentage of participants retained in the study until the conclusion	From enrollment to end of study at 8 months
Secondary	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.