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 control
    Usual Head Start activities
  • Experimental: Para Salud
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Tech University Health Sciences CenterLubbockTexas79430
Associate Dean for Research and Scholarship
806-743-7771
Research Associate
8067437771
Christina Esperat, PhD (PRINCIPAL_INVESTIGATOR)

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