Clinical trial NCT06831097: Early Childhood Obesity Among Rural Residents of West Texas
Official title: Early Childhood Obesity Among Rural Residents of West Texas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Children
Obesity prevention in children
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: University of Nevada, Las Vegas
First posted: 2025-02-17
Enrollment: 480
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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
* The inclusion criteria will be verified through children's enrollment records and the demographic information sheet. The parental/guardian participants will be the primary caregiver of each participating child, who lives in the same household of the child.

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.

Primary outcomes:
measure: Primary Outcome 1
timeFrame: Baseline (T0), 6 months (T1.), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group
measure: Primary Outcome 2
timeFrame: Baseline (T0), 6 months (T1.), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group
measure: Primary Outcome 3
timeFrame: Baseline (T0), 6 months (T1), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group.
measure: Primary Outcome 4
timeFrame: Baseline (T0), 6 months (T1), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group
measure: Primary Outcome 5
timeFrame: Baseline (T0), 6 months (T1), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References: