Early Childhood Obesity Among Rural Residents of West Texas
Part of paid clinical trials in Lubbock, Texas.
- Sponsor
- Texas Tech University Health Sciences Center
- Study ID
- NCT06831097
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - 4 Years
- Healthy Volunteers
- Accepted
Interventions
- "Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health) — BEHAVIORAL"Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health) Description: 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.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2025
- Status verified
- Feb 2025
- Primary completion
- Mar 30, 2030
- Completion
- Aug 30, 2030
Study Design
- Enrollment
- 480 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- PREVENTION
Arms
- No Intervention: wait-list controlUsual Head Start activities
- Experimental: Para SaludArm 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.
Primary Outcome Measure
Primary Outcome 1 [ Time Frame: Baseline (T0), 6 months (T1.), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group ]
Central Contacts
- Christina Esperat, PhD8062245817
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | Christina Esperat, PhD (PRINCIPAL_INVESTIGATOR) |
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