Healthy Eating Program for Childhood Obesity

Overseen By Martha Rojo, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Illiteracy

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

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve healthy eating habits among Hispanic families in rural Arkansas. It will test a culturally tailored program called the La CASA (Comunidad, Alimentación, Seguridad y Amén) Program, which includes cooking workshops and educational activities to determine if it helps mothers with healthy food preparation and increases children's fruit and vegetable intake. Participants will be divided into two groups: one receiving the healthy eating program and the other receiving informative videos on topics like mental health and dental care. The trial seeks mothers who have lived in the U.S. for at least a year, have a child aged 7 to 12, and can speak English or Spanish. As an unphased trial, this study offers a unique opportunity for families to contribute to research that could enhance community health and wellness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on healthy eating and cooking, so it's unlikely that medication changes are required.

What prior data suggests that this healthy eating program is safe for children?

Research has shown that family-based programs, such as the La CASA Program, are generally safe and effective for treating childhood obesity. These programs include activities that promote healthy eating and exercise, and participants typically manage them well. No negative effects have been reported from the La CASA Program itself.

In other studies on similar programs, participants often engage in activities like cooking workshops and group learning sessions. These activities are designed to be safe and supportive for both children and their families. Families frequently find these activities enjoyable and helpful, indicating they are well-received.

Overall, programs like La CASA have demonstrated a strong safety record. They focus on practical, everyday changes rather than medical treatments, which usually results in fewer safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the La CASA Program because it takes a community-centered approach to tackle childhood obesity. Unlike standard treatments, which often focus on individual diet plans or exercise regimens, this program leverages Community Health Workers to deliver personalized healthy eating modules directly in the home. Additionally, it incorporates cooking demonstrations in a church setting, fostering a supportive community environment. This unique method not only targets dietary habits but also engages families and communities, potentially leading to more sustainable lifestyle changes.

What evidence suggests that the Growing Healthy Children and Families in Rural Arkansas intervention could be effective for childhood obesity?

Research has shown that family-based programs like the La CASA Program, which participants in this trial may receive, effectively treat childhood obesity. These programs involve the whole family and focus on healthy eating habits. This trial will compare the La CASA Program with a Control/Attention Group that receives video recordings on various health topics. Studies indicate that community-based efforts can greatly help prevent children from becoming overweight or obese. A similar program succeeded by working with Hispanic families and emphasizing culturally important aspects. This approach helps families make lasting changes in their diet and lifestyle, leading to healthier children. ^{4 6 7 8 9}

Who Is on the Research Team?

Martha Rojo, PhD

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

This trial is for Hispanic children with obesity and their mothers. Participants will be from churches involved in the study, willing to attend cooking workshops, and report on diet and physical activity. They must not have conditions that exclude them as per the trial's specific criteria.

Inclusion Criteria

Living in the United States for at least one year

I have a child aged 7 to 12.

Exclusion Criteria

I cannot read or write in English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive seven healthy eating modules delivered by Community Health Workers in the home setting, plus two to three cooking demonstrations in the church setting.

14 weeks

Bi-weekly home visits, 2-3 church workshops

Control

Participants in the control group receive seven bi-weekly messaging videos via Facebook/WhatsApp.

12 weeks

7 video messages

Follow-up

Participants are monitored for changes in diet quality and dietary behaviors using questionnaires and Veggie Meter measures.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• La CASA (Comunidad, Alimentación, Seguridad y Amén) Program

Trial Overview

The CASA program aims to promote healthy eating among Hispanic families by providing culturally tailored interventions through churches. The effectiveness of this program on improving diet quality and changing cooking behaviors will be assessed in a comparison between an intervention group and a control group.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Seven healthy eating modules, delivered by Community Health Workers (CHW) in the home setting, for 14 weeks. Plus two to three cooking demonstration in the church setting.

Group II: Control/Attention Group Active Control 1 Intervention

Five video recordings via Facebook/WhatsApp for three months. Video topics: * Mental Health * Cord Blood Banking * Dental Care * Immunizations * Behavioral Problems in Children

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

In a randomized controlled trial involving 72 obese children, family-based behavioral treatment (FBBT) showed no significant difference in BMI reduction compared to a waiting-list control group, indicating that both groups experienced similar improvements in weight.

The treatment group did report significant reductions in systolic blood pressure and improvements in quality of life and eating attitudes, with no adverse effects noted, suggesting that while FBBT may not lead to greater weight loss, it can have positive health impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. Croker, H., Viner, RM., Nicholls, D., et al.[2022]

School-based interventions can lead to long-term positive health behavior changes in children, as they spend a significant amount of time in school, although their impact on weight measures is less clear due to common limitations.

Family-based interventions are effective in influencing children's behaviors, but issues like selection bias and high dropout rates can affect the reliability of their results; thus, a multidisciplinary approach that includes both school and family involvement is recommended for managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. Kelishadi, R., Azizi-Soleiman, F.[2022]

The introduction of a Bilingual Case Manager in a pediatric weight management clinic significantly increased enrollment of Hispanic families, boosting participation over ten-fold.

Outcomes for Hispanic families in the program were equal to or better than those of other racial/ethnic groups, highlighting the effectiveness of a family-centered and culturally sensitive approach in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a tertiary-care pediatric weight management clinic to better reach Spanish-speaking families. Guzman, A., Irby, MB., Pulgar, C., et al.[2021]

In a study of 75 participants in the Building Healthy Families program, those who achieved the largest reductions in BMI z-scores had high attendance and self-regulation skills, particularly among both children and mothers.

Successful outcomes were linked to mothers achieving clinically meaningful weight loss and children maintaining high attendance rates, suggesting that both parental involvement and self-regulation are crucial for effective obesity treatment in families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. Golden, CA., Heelan, KA., Hill, JL., et al.[2022]

Citations

1.

clinconnect.io

clinconnect.io/trials/NCT06565455

La CASA (Comunidad, Alimentación, Seguridad y Amén)

The La CASA Healthy Eating Intervention is a clinical trial aimed at tackling childhood obesity, particularly among Hispanic children.

2.

withpower.com

withpower.com/trial/healthy-eating-program-for-childhood-obesity-a75ae

Healthy Eating Program for Childhood Obesity

Research shows that family-based programs, like the La CASA Program, are effective in treating childhood obesity. Programs that involve families and focus on ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32887403/

Effectiveness of Community-Based Interventions Programs ...

The overall results of the study confirmed the effectiveness of community-based interventions in terms of childhood overweight/obesity prevention.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27884047/

Childhood obesity prevention cluster randomized trial for ...

The Healthy Families Study assessed the efficacy of a culturally targeted, family-based weight gain prevention intervention for Hispanic immigrant families.

5.

mdpi.com

mdpi.com/2072-6643/12/9/2680

Effectiveness of Community-Based Interventions Programs ...

... program. The overall results of the study confirmed the effectiveness of community-based interventions in terms of childhood overweight/obesity prevention.

6.

ajpmonline.org

ajpmonline.org/article/S0749-3797(12)00885-9/fulltext

Latina Voices in Childhood Obesity

This is a qualitative pilot study with 12 Latina mothers using Photovoice to identify barriers and opportunities for physical activity for their children.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5267322/

Home visitation programs: An untapped opportunity for the ...

This concept paper proposes an innovative model of obesity prevention implemented in infancy and sustained throughout early childhood.

8.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/367446

Family Intervention to Prevent Childhood Obesity

The study's intervention is a parenting/caregiver training program that includes 1-month of weekly in-person sessions plus multi-media ...

9.

reporter.nih.gov

reporter.nih.gov/project-details/9458227

Pediatric Obesity Management Intervention Trial for ...

The POM trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and ...