ObesityNCT06831097
Early Childhood Obesity Among Rural Residents of West Texas
A study testing "Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health) in people with Obesity, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- "Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- "Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health)
- Keywords
- Obesity, Children, Obesity prevention in children
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health)Behavioural
"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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: "Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), 6 months (T1), 12 months (T2), and follow-ups at 6 and 12 months after the intervention starts for the control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Dec 2025
- Primary completion30 Mar 2026
- Study completion30 May 2026
Why it stopped: Enrollment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831097
- Sponsor's protocol ID
- 25-0166
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will be meeting with the Community Advisory Board before this decision will be made.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Obesity Among Rural Residents of West Texas
- ClinicalTrials.gov ID
- NCT06831097
- Acronym / sponsor ID
- 25-0166
- Conditions
- Obesity
- Keywords
- Obesity, Children, Obesity prevention in children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| wait-list control | No intervention | –Usual Head Start activities |
| Para Salud | Experimental | Behavioral: "Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health)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. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Behavioural | Para Salud |
Primary outcome
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
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.
Primary Outcome 2
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
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.
Primary Outcome 3
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.
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.
Primary Outcome 4
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
Nutrition Knowledge: This will be assessed using the Nutritional Knowledge Assessment (NKT), which includes questions on energy intake, nutrient content, and food knowledge.
Primary Outcome 5
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
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided. We will be meeting with the Community Advisory Board before this decision will be made.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Comidas Para Salud" (Food for Health), "Pasos Para Salud" (Steps for Health), "Jardines Para Salud" (Gardens for Health) in people with Obesity, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.