Nutrition, Physical Activity, and Gardening for Childhood Obesity

Overseen By Christina Esperat, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Texas Tech University Health Sciences Center

Disqualifiers: Physical, mental disabilities, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to find better ways to prevent and manage obesity in preschool children in rural Texas through healthy eating, exercise, and gardening activities. It will test three approaches: teaching healthy eating habits (Comidas Para Salud), using fun games to boost physical activity (Pasos Para Salud), and involving families in gardening projects (Jardines Para Salud). The goal is to determine if these activities can improve health markers like weight and body fat and encourage healthier lifestyle choices, such as increased physical activity and better eating habits. Families with children aged 3-4 enrolled in certain programs in the Texas High Plains, who do not have diagnosed physical or mental disabilities, may be a good fit for this trial. As an unphased trial, this study offers families the chance to contribute to innovative strategies for healthier childhoods.

Do I need to stop my child's current medications for this trial?

The trial information does not specify whether children need to stop taking their current medications. It focuses on nutrition, physical activity, and gardening interventions for obesity prevention.

What prior data suggests that these interventions are safe for preschool children?

Research shows that the activities in the Para Salud study, including Comidas Para Salud, Pasos Para Salud, and Jardines Para Salud, are generally safe and well-tolerated.

For Comidas Para Salud, evidence indicates that promoting healthy eating, such as increasing fruit and vegetable intake, is safe for children. Studies have found that reducing sugary drinks can help alleviate obesity-related issues without causing harm.

Pasos Para Salud involves increasing physical activity through fun exercises like video games that require movement. Evidence suggests these activities are safe and beneficial for children, enhancing their physical health without negative effects.

Jardines Para Salud includes gardening activities. Research shows that gardening can improve children's body mass index (BMI) and waist size, and it is considered safe. These activities also promote a healthy lifestyle without risks.

Overall, these activities aim to improve lifestyle habits, and research supports them as safe ways to manage childhood obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for childhood obesity because they integrate nutrition education, physical activity, and gardening in a way that's different from current options. "Comidas Para Salud" teaches healthy eating habits directly to preschoolers and their caregivers, aiming to create lasting dietary changes. "Pasos Para Salud" uses interactive video games to make physical activity fun, encouraging kids to move more and sit less. Meanwhile, "Jardines Para Salud" involves children and their families in gardening, making it a hands-on way to promote a healthy lifestyle. This holistic approach targets lifestyle changes rather than just focusing on diet or exercise alone, offering a comprehensive strategy to tackle childhood obesity.

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

This trial will evaluate the effectiveness of three programs—Comidas Para Salud, Pasos Para Salud, and Jardines Para Salud—in reducing childhood obesity. Studies have shown that programs focusing on nutrition, exercise, and gardening can help reduce obesity in children. Comidas Para Salud, which participants in this trial may receive, teaches kids healthy eating habits, crucial for managing weight. Research shows that Pasos Para Salud, another program in this trial, uses fun video games to encourage physical activity, reducing sedentary behavior and improving fitness. Jardines Para Salud, also part of this trial, involves gardening activities to promote a healthy lifestyle. Evidence suggests these programs help kids eat more fruits and vegetables and improve their body mass index (BMI) and waist size. These programs hold promise for tackling obesity in young children within communities. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for preschool children aged 3-4 years living in rural Texas, specifically targeting young Hispanic children at higher risk of obesity. Participants should be interested in interventions involving nutrition, physical activity, and gardening to reduce obesity-related metrics.

Inclusion Criteria

Parental consent

Enrolled in the participating HS programs

Live in a selected county in Texas High Plains (Crosby, Floyd, Garza, Hale, Hockley, Lamb, Lubbock, Lynn, and Terry County)

Exclusion Criteria

Health Status: Children with diagnosed physical or mental disabilities according to enrollment records

Lack of Consent: Children without parental/guardian consent to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in nutrition education, physical activity, and gardening interventions to prevent and control obesity

12 months

Regular visits for intervention activities

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

Follow-up assessments at 6 and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Comidas Para Salud
• Jardines Para Salud
• Pasos Para Salud

Trial Overview 'Para Salud' study tests three community-based programs: 'Comidas Para Salud' focusing on healthy eating, 'Pasos Para Salud' encouraging physical activity, and 'Jardines Para Salud' promoting gardening. The goal is to see if these can lower obesity measures like BMI percentile over two years.

How Is the Trial Designed?

Group I: Para Salud Experimental Treatment 1 Intervention

Arm Description: "Comidas Para Salud" (Food for Health), will focus on assisting young children to learn skills in healthy eating. The Bienestar Preschool Curriculum is home-based and directed to both the primary caregivers as well as the child participants. The "Pasos Para Salud" (Steps for Health), which will use IVG/exergaming to increase children's physical activity level and reduce their sedentary behavior. "Jardines Para Salud" (Gardens for Health), will involve planting gardens in the HS settings and supervised home gardening projects for the preschool participants and their parents/guardians. This will instill the value of gardening and gardening skills in promoting a healthy lifestyle.

Group II: wait-list control Active Control 1 Intervention

Usual Head Start activities

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

University of Nevada, Las Vegas

Collaborator

Trials

81

Recruited

14,700+

Published Research Related to This Trial

School-based interventions that combine diet and physical activity are the most effective strategies for preventing childhood obesity, based on a systematic review of 41 studies.

There is a need for more rigorous research in non-school settings, as evidence for preschool, community, and home-based interventions is limited and varied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to prevent global childhood overweight and obesity: a systematic review. Bleich, SN., Vercammen, KA., Zatz, LY., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06831097

Early Childhood Obesity Among Rural Residents of West ... The Para Salud study is a longitudinal, community-based participatory research (CBPR) initiative aimed at preventing and controlling obesity among preschool ...

2. withpower.com withpower.com/trial/nutrition-physical-activity-and-gardening-for-childhood-obesity-63f04

Nutrition, Physical Activity, and Gardening for Childhood ... Primary Objective: To assess the effectiveness of the Para Salud interventions in reducing obesity-related metrics, including BMI percentile, waist-to-height ...

3. reporter.nih.gov reporter.nih.gov/project-details/10003235

Obesity Prevention in Head Start: The Miranos! Program The proposed study is designed to test the efficacy of an early childhood obesity prevention program, “Obesity Prevention in Head Start: The Míranos! Program”, ...

4. mskcc.org mskcc.org/departments/psychiatry-behavioral-sciences/immigrant-health/working-diverse-communities/consumo-de-opciones-mas-ideales-de-alimentos-eating-more-ideal-food-options

Consumo de Opciones Más Ideales De Alimentos (Eating ... Childhood obesity is a significant predictor of obesity in adulthood. Parental obesity more than doubles the risk of future adult obesity among obese and ...

5. researchgate.net researchgate.net/publication/51979204_Results_of_a_Multi-level_Intervention_to_Prevent_and_Control_Childhood_Obesity_among_Latino_Children_The_Aventuras_Para_Nios_Study

Results of a Multi-level Intervention to Prevent and Control ... A promotora-based behavioral intervention was efficacious at changing parental factors and child obesity-related health behaviors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9920526/

Association between Food, Beverages and Overweight ... In conclusion, a higher intake of sugar-sweetened beverages and a higher intake of fast food was identified as the primary dietary risk factors ...

7. publications.aap.org publications.aap.org/pediatrics/article/153/4/e2023063749/196881/Universal-Free-School-Meals-Policy-and-Childhood

Universal Free School Meals Policy and Childhood Obesity CEP increases school meal participation by providing free meals to all students; however, its impact on obesity remains uncertain.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323000339

Unhealthy Food and Beverage Consumption in Children ... Evidence indicated that consumption of sugar-sweetened beverages (SSBs) and unhealthy foods in childhood may increase BMI/BMI z-score, percentage body fat, or ...

9. cdc.gov cdc.gov/obesity/family-action/index.html

Preventing Childhood Obesity: 6 Things Families Can Do 1. Model a healthy eating pattern. Offer a variety of fruits and vegetables throughout the day. Frozen and canned fruits and vegetables are often less ...

10. who.int who.int/news/item/03-07-2023-who-recommends-stronger-policies-to-protect-children-from-the-harmful-impact-of-food-marketing

WHO recommends stronger policies to protect children ... TheWHO guideline on Policies to protect children from the harmful impact of food marketing will be available from 03 July 2023, 12:30 pm CEST.