Early Childhood Obesity Among Rural Residents of West Texas

NCT06831097 | Not Yet Recruiting DMC

• 1 other identifier: 25-0166
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; Children; Obesity prevention in children

Outcome Measures

Primary Outcomes (5)

• Primary Outcome 1

  Height and Weight: These will be measured using a stadiometer and electronic scale (Tanita). The measurements will include Body Mass Index (BMI) percentile adjusted for age and gender, as well as body fat percentage.

  Baseline (T0), 6 months (T1.), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group

• Primary Outcome 2

  Waist Circumference (WC) and Waist-to-Height Ratio (WHTR): WC will be measured at the top of the right ilium, and WHTR will be calculated.

  Baseline (T0), 6 months (T1.), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group

• Primary Outcome 3

  A self-administered survey will collect demographic, socioeconomic, and lifestyle data, including TV in the bedroom, screen time, parental support for physical activity, sugar-sweetened beverage intake, fruit and vegetable intake, frequency of family meals, and fast food consumption.

  Baseline (T0), 6 months (T1), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group.

• Primary Outcome 4

  Nutrition Knowledge: This will be assessed using the Nutritional Knowledge Assessment (NKT), which includes questions on energy intake, nutrient content, and food knowledge.

  Baseline (T0), 6 months (T1), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group

• Primary Outcome 5

  Physical activity levels will be assessed using ActiGraph accelerometers, which will record daily activity counts and categorize them into sedentary, light, moderate, and vigorous levels.

  Baseline (T0), 6 months (T1), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group

Study Arms (2)

wait-list control

NO INTERVENTION

Usual Head Start activities

Para Salud

EXPERIMENTAL

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.

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

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.

Para Salud

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead
• University of Nevada, Las Vegas: collaborator

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Food; Health; Gardens

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Population Characteristics; Agriculture; Technology, Industry, and Agriculture; Non-Medical Public and Private Facilities

Central Study Contacts

Christina Esperat, PhD

CONTACT

8062245817; christina.esperat@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (1)