Family Wellness Education for Childhood Obesity

Recruiting at 1 trial location

Overseen By Julie Plasencio, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ana Maria Linares

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

57 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Ana M Linares, DNS

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for Latinx families of Mexican or Central American descent living in Central Kentucky, with at least one parent aged 18+ and a child between 2-5 years old who is overweight or obese. They must plan to stay in the area for at least a year and have internet access.

Inclusion Criteria

Latinx family of Mexican or Central American descent

Intention to remain in Central Kentucky for at least a year after recruitment

Access to the internet.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a culturally tailored family-oriented intervention 'AyUDA' to improve healthy feeding and lifestyle practices

6 weeks

Weekly virtual sessions for the experimental group; weekly phone calls for the comparator group

Follow-up

Participants are monitored for changes in dietary behavior and anthropometric measurements

6 months

Data collection at 1, 3, and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The 'AyUDA' program aims to engage parents in healthy lifestyle choices for their young children to reduce childhood obesity. It's a study comparing two methods: one using telehealth deep cultural level group sessions, and another with traditional educational materials.

How Is the Trial Designed?

Group I: Virtual Experimental Treatment 1 Intervention

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

Group II: Traditional Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ana Maria Linares

Lead Sponsor

Trials

2

Recruited

100+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+