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

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Para Salud study is a longitudinal, community-based participatory research (CBPR) initiative aimed at preventing and controlling obesity among preschool children in rural Texas. The study will implement evidence-based interventions targeting nutrition, physical activity, and gardening. The interventions are designed to improve health outcomes, specifically in reducing obesity-related metrics among young Hispanic children, who are at a higher risk of obesity due to social determinants of health. Primary Objective: To assess the effectiveness of the Para Salud interventions in reducing obesity-related metrics, including BMI percentile, waist-to-height ratio, and percentage body fat, among preschool children aged 3-4 years in the Texas High Plains over a 24-month period. Secondary Objective: To evaluate the impact of the Para Salud interventions on increasing physical activity levels, improving dietary habits (such as increasing fruit and vegetable intake), and reducing sedentary behavior and sugar-sweetened beverage consumption among the study participants.

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.

Is the Nutrition, Physical Activity, and Gardening program safe for children?

Research on similar programs, like Texas Sprouts and Texas!Grow!Eat!Go!, shows they are generally safe for children. These programs focus on improving diet and physical activity without reported safety issues. ^{1 2 3 4 5}

How does the treatment 'Comidas Para Salud, Jardines Para Salud, Pasos Para Salud' differ from other treatments for childhood obesity?

This treatment is unique because it combines nutrition education, physical activity, and gardening to address childhood obesity, focusing on improving dietary habits and increasing physical activity through engaging, school-based programs. Unlike traditional treatments that may focus solely on diet or exercise, this approach integrates multiple lifestyle changes in a holistic manner. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Comidas Para Salud, Jardines Para Salud, Pasos Para Salud for childhood obesity?

Research shows that school-based programs combining gardening, nutrition, and physical activity can improve dietary habits and hold promise for preventing childhood obesity. Additionally, interventions involving physical activity and nutritional counseling with parental involvement have been effective in preventing obesity in young children. ^{3 4 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. Peru pubmed.ncbi.nlm.nih.gov

[Interventions to prevent the development of overweight and obesity in children younger than five years]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Perceptions of middle school educators in Hawai'i about school-based gardening and child health. [2021]

3. England pubmed.ncbi.nlm.nih.gov

School-based gardening, cooking and nutrition intervention increased vegetable intake but did not reduce BMI: Texas sprouts - a cluster randomized controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Interventions to prevent global childhood overweight and obesity: a systematic review. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Prevention and treatment of obesity in children]. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Sustainability via Active Garden Education (SAGE): results from two feasibility pilot studies. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Reductions in the energy content of meals served in the Chilean National Nursery School Council Program did not consistently decrease obesity among beneficiaries. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of a Gardening and Physical Activity Intervention in Title 1 Schools: The TGEG Study. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Childhood obesity: food, nutrient, and eating-habit trends and influences. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Is School Gardening Combined with Physical Activity Intervention Effective for Improving Childhood Obesity? A Systematic Review and Meta-Analysis. [2021]