Early Childhood Obesity Among Rural Residents of West Texas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2030-08-30

Brief Summary

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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.

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Detailed Description

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The study will enroll 480 children aged 3-4 years from Head Start (HS) programs in the rural areas of Crosby, Floyd, Garza, Hale, Hockley, Lamb, Lubbock, Lynn, and Terry counties, Texas. The population is predominantly Hispanic and of low socioeconomic status, with a significant proportion living in medically underserved areas.

The study is in the implementation and evaluation phase, focusing on interventions aimed at preventing and controlling obesity in a specific high-risk population of preschool-aged children in rural Texas.

Participants will be enrolled from Head Start (HS) programs in nine counties: Crosby, Floyd, Garza, Hale, Hockley, Lamb, Lubbock, Lynn, and Terry. The study will be directed through the School of Nursing (SON) at Texas Tech University Health Sciences Center, specifically through the Larry Combest Community Health and Wellness Center (LCCHWC), a nurse-led federally-qualified health center located in East Lubbock. If needed, the LCCHWC has established facilities for implementing the study interventions, including classrooms for nutrition educational and physical activity programs and spaces for gardening projects, having been a primary site for the USDA-funded research project.

Comidas Para Salud (Food for Health): Nutrition education and home-based interventions to teach healthy eating habits.

Pasos Para Salud (Steps for Health): Physical activity intervention using interactive video gaming to increase daily physical activity and reduce sedentary behavior.

Jardines Para Salud (Gardens for Health): Gardening activities conducted at both school and home to promote physical activity and healthy eating through hands-on experiences in growing fruits and vegetables.

The overall study duration is 5 years, including recruitment, intervention implementation, and follow-up assessments.

Each participant will be involved in the study for 24 months, which includes baseline assessments, 12 months of intervention, and follow-up assessments at 6 and 12 months post-intervention.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In this 5-year project, a longitudinal CBPR research design and a mixed method approach will be employed. We will use a group randomized trial (GRT) with two arms (an intervention arm and a wait-list control arm) to test the effectiveness of the Para Salud interventions compared to usual care received from the Head Start (HS) programs, because children are nested in class at the HS centers and the Pasos Para Salud intervention will be delivered in in classrooms. Data will be collected pre-intervention, at the mid-point intra-intervention, immediately post-intervention, and 6 and 12 months post-intervention. Cohort 1 will consist of the four rural sites from Terry, Hockley, Lamb and Lubbock counties. We will add Cohort 2 consisting of HS students from Hale, Floyd, Crosby, Garza and Lynn counties in project Y3.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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wait-list control

Usual Head Start activities

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

"Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health)

Intervention Type 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.

Interventions

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"Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health)

"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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in the participating HS programs,
* Aged 3-4 years,
* Live in a selected county in Texas High Plains (Crosby, Floyd, Garza, Hale, Hockley, Lamb, Lubbock, Lynn, and Terry County)
* Without a diagnosed physical or mental disability according to enrollment records,
* Parental consent

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes