Family Wellness Education for Childhood Obesity

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a family-focused program can reduce early childhood obesity in Latinx children aged 2-5. The program, AyUDA (Aprender y Utilizar Decisiones Apreciables - Learning and Utilizing Significant Choices), teaches healthy eating and lifestyle habits. Families will either join virtual sessions (AyuDa Virtual) or receive written materials (AyuDa Written), both designed to promote healthy behavior changes. Latinx families from Mexican or Central American backgrounds with young children who are overweight or obese, living in Central Kentucky, and having internet access are encouraged to participate. As an unphased trial, this study provides families a unique chance to contribute to research that may improve health outcomes for young children.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on family education and lifestyle changes for childhood obesity.

What prior data suggests that this family-oriented intervention is safe for childhood obesity?

Research has shown that virtual education programs for childhood obesity are generally well-liked. Studies have found that these online programs can improve children's lifestyle habits and involve parents in the process. While many recognize the benefits of using technology for health education, some have mixed feelings about it.

For written materials, evidence suggests that focusing on diet, behavior changes, and physical activity is safe and effective. Programs combining these strategies tend to reduce childhood obesity effectively.

These findings indicate that both virtual and written methods are safe and can help manage childhood obesity. Studies have not reported any major safety concerns with these educational approaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for childhood obesity because they offer a culturally tailored and interactive approach to education, which is not commonly found in standard care options like dietary counseling or exercise programs. The "AyuDa Virtual" treatment is unique because it provides engaging virtual group sessions led by a culturally similar health educator, making it easier for families to connect and implement behavior changes. Meanwhile, the "AyuDa Written" treatment offers flexibility with written materials and weekly phone support, ensuring families can access the information at their convenience while still receiving personalized guidance. Both treatments focus on making significant lifestyle choices, aiming to empower families in a culturally relevant way.

What evidence suggests that this trial's interventions could be effective for childhood obesity?

Research has shown that online programs for childhood obesity can be as effective as traditional, in-person methods. One study found that a virtual program for families improved children's healthy habits and increased parental support, similar to in-person programs. Another study highlighted that online methods are well-received and can make managing obesity more flexible and accessible for families. In this trial, participants in the AyuDa Virtual arm will engage in weekly virtual group sessions, potentially helping children adopt healthier lifestyles by involving families through online platforms. Meanwhile, the AyuDa Written arm will provide the same educational materials in writing, supplemented by weekly phone calls for guidance. ^{2 3 4 6 7}

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

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

Latinx family of Mexican or Central American descent

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11505602/

Effectiveness of Smartphone App for the Treatment of ... Background: Pediatric obesity treatment is based on high-intensity lifestyle counseling. However, high dropout rates and low effectiveness have been reported, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25777493/

A Virtual Childhood Obesity Collaborative: Satisfaction ... This study demonstrated that a virtual childhood obesity collaborative is an acceptable delivery method for continuing education.

3. pediatrics.jmir.org pediatrics.jmir.org/2022/4/e40431

Evaluating the Effectiveness of a Family-Based Virtual ... The study findings suggested that the virtual GH program was as effective as the blended program for improving child lifestyle behaviors and parental support– ...

4. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02640-1

The effectiveness of pediatric obesity prevention policies: a ... In the current meta-analysis, we summarized the results of controlled trials that evaluated the effect of obesity prevention policies in children and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36054663/

Evaluating the Effectiveness of a Family-Based Virtual ... The virtual program has the potential to improve the flexibility and scalability of family-based childhood obesity management interventions.

6. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20593-8

Effect of virtual education on health responsibility of ... The current research aimed to investigate the effect of virtual education programs on the health responsibility of overweight students during ...

7. ajmc.com ajmc.com/view/digital-learning-could-prevent-obesity-in-low-income-children

Digital Learning Could Prevent Obesity in Low-Income ... In 30-minute individual virtual interviews, home visitation staff voiced positive and negative attitudes toward using technology during home ...