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Eine Studie entspricht den Filterkriterien
Kartenansicht
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05867433 ist eine interventionsstudie zur Untersuchung von Kardiovaskuläre Erkrankungen, Ernährung, Körperliche Aktivität und hat den Status offene rekrutierung. Die Studie startete am 27. September 2023 und soll 500 Teilnehmer aufnehmen. Durchgeführt von Texas A&M University ist der Abschluss für 15. April 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 12. September 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.
Offizieller Titel
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
Erkrankungen
Kardiovaskuläre ErkrankungenErnährungKörperliche AktivitätPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- IRB2022-1159D
- R01MD018214 (Zuwendung/Vertrag der US-NIH)
NCT-Nummer
Studienbeginn (tatsächlich)
2023-09-27
Zuletzt aktualisiert
2025-09-12
Studienende (vorauss.)
2027-04-15
Geplante Rekrutierung
500
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellSTHS Intervention Participants in this group (10 schools) will participate in the STHS program. | 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. |
AndereUsual 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. | Übliche Versorgung No STHS program
The usual care group will be offered the same activities as the intervention group after the conclusion of the research study. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Presence or absence of metabolic syndrome (MetS) | 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 | 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 | 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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Blood pressure level | 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 | 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 | 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 | 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 | 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 | Height will be measured using a stadiometer in inches. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Weight | 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) | 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 | 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 | 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 | Sedentary time will be measured using Actigraph accelerometers. | Baseline to 9 months |
Time spent sleeping | Sleep time will be measured using Actigraph accelerometers. | Baseline to 9 months |
Physical fitness capacity estimation | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 |
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
8 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- > 50 6th and 7th grade students
- > 40% economically disadvantaged students
- > 40% Black and Hispanic students
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
Texas A&M UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Zentrale Studienkontakte
Kontakt: Jacob S Szeszulski, PhD, 972-231-5362, [email protected]
Kontakt: Alexandra L MacMillan Uribe, PhD, 972-952-9275, [email protected]
1 Studienstandorte in 1 Ländern
Texas
Texas A&M AgriLife Dallas Center, Dallas, Texas, 75252, United States
Jacob Szeszulski, PhD, Kontakt, 972-231-5362, [email protected]
Alexander MacMillan Uribe, PhD, Kontakt, 972-952-9275, [email protected]
Offene Rekrutierung