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Sterke tieners voor gezonde scholen veranderen van club: een aanpak voor burgerbetrokkenheid om lichaamsbeweging en gezonde eetomgevingen te verbeteren

29 september 2026 bijgewerkt door: Texas A&M University

Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the Strong Teens for Healthy Schools (STHS) program on cardiovascular disease-related outcomes. STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (CVD) outcomes among 6th and 7th-grade students.

Title 1 middle schools in Texas (n=20) with > 40% Hispanic and Black students will be randomized at baseline to the intervention condition (STHS program) or control condition (will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming) (n=20-25 students per school).

The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.

Studietype

Ingrijpend

Inschrijving (Geschat)

500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

8 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

School Inclusion Criteria:

  • > 50 6th and 7th grade students
  • > 40% economically disadvantaged students
  • > 40% Black and Hispanic students

School Exclusion Criteria:

Student Inclusion Criteria:

  • 6th or 7th grade student
  • Attend a Title 1 middle school that is participating in the STHS intervention
  • Read and understand English

Student Exclusion Criteria:

  • Participation in a weight loss program in the past 3 months
  • Presence of a condition that prevents participation in physical activity

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: STHS Intervention

Participants in this group (10 schools) will participate in the STHS program.
Gedragsmatig: STHS Intervention

STHS program

The intervention group (10 schools) will participate in the STHS program. During the fall semester (September to December), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that provide education on civic engagement, healthy eating, and physical activity. During the spring semester (February to May), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that focus on implementing the school health environmental change project and receive support for maintaining individual-level healthy eating and physical activity behaviors.
Ander: Usual Care

Participants in this group (10 schools) will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming.
Gedragsmatig: Usual Care

No STHS program

The usual care group will be offered the same activities as the intervention group after the conclusion of the research study.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Presence or absence of metabolic syndrome (MetS)
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

MetS is present after identifying abdominal obesity plus at least two of the four other MetS Risk factors: high blood pressure, high blood sugar, low HDL cholesterol, and high triglyceride levels.

MetS = (abdominal obesity) + (2 of 4 other MetS Risk factors)

Measures to determine MetS risk factors:

  1. Abdominal obesity: waist circumference >90th percentile for child's sex and age
  2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
  3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
  4. Low HDL cholesterol: HDL cholesterol <1.03 mmol/L
  5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Change in the number of MetS risk factors
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors)

Measures to determine MetS risk factors:

  1. Abdominal obesity: waist circumference >90th percentile for child's sex and age
  2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
  3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
  4. Low HDL cholesterol: HDL cholesterol <1.03 mmol/L
  5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Positive Youth Development score
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Positive youth development will be measured using a 5 C's Model of Positive Youth Development Scale-Short Form (PYD-SF): A 34-item scale that assesses the strength of psychological, behavioral, and social development in youth.

The five dimensions measured are:

  1. Competence (sense of proficiency)
  2. Confidence (self-worth, self-efficacy)
  3. Character (adherence to societal and cultural rules)
  4. Connection (bonds with people and institutions)
  5. Caring (sympathy and empathy towards others)
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood pressure level
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of blood glucose
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Glucose will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Waist circumference
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of HDL cholesterol
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

HDL-C will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of serum triglycerides
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Triglycerides will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Height
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Height will be measured using a stadiometer in inches.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Weight
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Weight will be measured with a scale in pounds.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Body mass index (BMI)
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Weight will be measured with a scale, and height will be measured using a stadiometer. BMI will be calculated as BMI = (weight (lb)/height (inches)2) x 703.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of subdermal carotenoids
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

The concentration of subdermal carotenoids will assess the changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Accelerometer-derived physical activity estimation
Tijdsspanne: Baseline to 9 months

Physical activity will be measured using Actigraph accelerometers. Measurements will include light physical activity (PA), moderate PA, moderate to vigorous PA, and vigorous PA.
Baseline to 9 months
Sedentary time
Tijdsspanne: Baseline to 9 months

Sedentary time will be measured using Actigraph accelerometers.
Baseline to 9 months
Time spent sleeping
Tijdsspanne: Baseline to 9 months

Sleep time will be measured using Actigraph accelerometers.
Baseline to 9 months
Physical fitness capacity estimation
Tijdsspanne: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness.
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
School physical activity and nutrition environment assessment
Tijdsspanne: Baseline to 9 months

The school's physical activity and nutrition environments will be measured using a self-reported School Environment Survey.
Baseline to 9 months
Assessment of perceptions of school environments and school-specific dietary intake patterns
Tijdsspanne: Baseline to 9 months

Perceptions related to physical activity and nutrition within the school setting will be measured using the Perceptions of the Environment and Patterns of Diet at School (PEA-PODS) survey.
Baseline to 9 months
Assessment of perceived sociopolitical control
Tijdsspanne: Baseline to 9 months

Perceived sociopolitical control will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' perceived sociopolitical control (i.e., participation in advocacy programs and optimism for change).
Baseline to 9 months
Assessment of assertiveness
Tijdsspanne: Baseline to 9 months

Assertiveness will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' assertiveness (i.e., ability to engage with adults and peers).
Baseline to 9 months
Assessment of participatory competence and decision-making
Tijdsspanne: Baseline to 9 months

Participatory competence and decision-making will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' participatory competence and decision-making (i.e., ability to influence group decision-making).
Baseline to 9 months
Assessment of advocacy outcome efficacy
Tijdsspanne: Baseline to 9 months

Advocacy outcome efficacy will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' advocacy outcome efficacy (i.e., belief in their ability to work with others to improve the school's physical activity and nutrition environment).
Baseline to 9 months
Peer concentration of subdermal carotenoids
Tijdsspanne: Baseline to 9 months

The concentration of subdermal carotenoids will assess peers' engagement in health behaviors changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy.
Baseline to 9 months
Peer Body mass index (BMI)
Tijdsspanne: Baseline to 9 months

Peers' engagement in health behaviors will be measured by the change in peers' BMI. Weight will be measured with a scale, and height will be measured using a stadiometer. Calculate BMI with the formula: BMI = (weight (lb)/height (inches)2) x 703.
Baseline to 9 months
Peer physical fitness capacity estimation
Tijdsspanne: Baseline to 9 months

Peers' engagement in health behaviors will be measured by the change in peers' physical fitness. Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness.
Baseline to 9 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Texas A&M University

Medewerkers

National Institute on Minority Health and Health Disparities (NIMHD)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 september 2023

Primaire voltooiing (Geschat)

15 april 2027

Studie voltooiing (Geschat)

15 april 2027

Studieregistratiedata

Eerst ingediend

11 april 2023

Eerst ingediend dat voldeed aan de QC-criteria

10 mei 2023

Eerst geplaatst (Werkelijk)

22 mei 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

29 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB2022-1159D
  • R01MD018214 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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