[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505903":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":95,"studyPopulation":87,"armGroups":96,"interventions":108,"overallOfficials":87,"centralContacts":116,"locations":126,"responsibleParty":146,"collaborators":148,"id":152,"slug":87,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":87,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":158,"minAge":159,"maxAge":87,"enrollmentInfo":160,"targetDuration":87,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":87,"overallStatus":129,"whyStopped":87,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Texas A&M University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":87},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"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.\n\nMetS = (abdominal obesity) + (2 of 4 other MetS Risk factors)\n\nMeasures to determine MetS risk factors:\n\n1. Abdominal obesity: waist circumference \\>90th percentile for child's sex and age\n2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)\n3. High blood glucose: blood glucose ≥5.6 mmol\u002FL or known diabetes\n4. Low HDL cholesterol: HDL cholesterol \\\u003C1.03 mmol\u002FL\n5. High triglyceride level: Triglyceride level ≥ 1.7mmol\u002FL","Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention",{"measure":14,"description":15,"timeFrame":12},"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)\n\nMeasures to determine MetS risk factors:\n\n1. Abdominal obesity: waist circumference \\>90th percentile for child's sex and age\n2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)\n3. High blood glucose: blood glucose ≥5.6 mmol\u002FL or known diabetes\n4. Low HDL cholesterol: HDL cholesterol \\\u003C1.03 mmol\u002FL\n5. High triglyceride level: Triglyceride level ≥ 1.7mmol\u002FL",{"measure":17,"description":18,"timeFrame":12},"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.\n\nThe five dimensions measured are:\n\n1. Competence (sense of proficiency)\n2. Confidence (self-worth, self-efficacy)\n3. Character (adherence to societal and cultural rules)\n4. Connection (bonds with people and institutions)\n5. Caring (sympathy and empathy towards others)",[20,23,26,29,32,35,38,41,44,47,51,54,57,60,63,66,69,72,75,78,81,84],{"measure":21,"description":22,"timeFrame":12},"Blood pressure level","Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.",{"measure":24,"description":25,"timeFrame":12},"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.",{"measure":27,"description":28,"timeFrame":12},"Waist circumference","Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.",{"measure":30,"description":31,"timeFrame":12},"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.",{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":37,"timeFrame":12},"Height","Height will be measured using a stadiometer in inches.",{"measure":39,"description":40,"timeFrame":12},"Weight","Weight will be measured with a scale in pounds.",{"measure":42,"description":43,"timeFrame":12},"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)\u002Fheight (inches)2) x 703.",{"measure":45,"description":46,"timeFrame":12},"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.",{"measure":48,"description":49,"timeFrame":50},"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",{"measure":52,"description":53,"timeFrame":50},"Sedentary time","Sedentary time will be measured using Actigraph accelerometers.",{"measure":55,"description":56,"timeFrame":50},"Time spent sleeping","Sleep time will be measured using Actigraph accelerometers.",{"measure":58,"description":59,"timeFrame":12},"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\u002Fhour and a progressive 0.5-km\u002Fhour 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.",{"measure":61,"description":62,"timeFrame":50},"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.",{"measure":64,"description":65,"timeFrame":50},"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.",{"measure":67,"description":68,"timeFrame":50},"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).",{"measure":70,"description":71,"timeFrame":50},"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).",{"measure":73,"description":74,"timeFrame":50},"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).",{"measure":76,"description":77,"timeFrame":50},"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).",{"measure":79,"description":80,"timeFrame":50},"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.",{"measure":82,"description":83,"timeFrame":50},"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)\u002Fheight (inches)2) x 703.",{"measure":85,"description":86,"timeFrame":50},"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\u002Fhour and a progressive 0.5-km\u002Fhour 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.",null,{"allocation":89,"interventionModel":90,"interventionModelDescription":91,"primaryPurpose":92,"observationalModel":87,"timePerspective":87,"maskingInfo":93},"RANDOMIZED","PARALLEL","School-based cluster randomized controlled trial","PREVENTION",{"masking":94,"maskingDescription":87,"whoMasked":87},"NONE","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.\n\nTitle 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).\n\nThe 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.",[97,103],{"label":98,"type":99,"description":100,"interventionNames":101},"STHS Intervention","EXPERIMENTAL","Participants in this group (10 schools) will participate in the STHS program.",[102],"Behavioral: STHS Intervention",{"label":104,"type":6,"description":105,"interventionNames":106},"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.",[107],"Behavioral: Usual Care",[109,113],{"type":110,"name":98,"description":111,"armGroupLabels":112,"otherNames":87},"BEHAVIORAL","STHS program\n\nThe 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.",[98],{"type":110,"name":104,"description":114,"armGroupLabels":115,"otherNames":87},"No STHS program\n\nThe usual care group will be offered the same activities as the intervention group after the conclusion of the research study.",[104],[117,122],{"name":118,"role":119,"phone":120,"phoneExt":87,"email":121},"Jacob S Szeszulski, PhD","CONTACT","972-231-5362","jacob.szeszulski@ag.tamu.edu",{"name":123,"role":119,"phone":124,"phoneExt":87,"email":125},"Alexandra L MacMillan Uribe, PhD","972-952-9275","lexi.macmillanuribe@ag.tamu.edu",[127],{"facility":128,"status":129,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"Texas A&M AgriLife Dallas Center","RECRUITING","Dallas","Texas","75252","United States","US",{"type":136,"coordinates":137},"Point",[138,139],-96.80667,32.78306,{"lat":139,"lon":138},[142,144],{"name":143,"role":119,"phone":120,"phoneExt":87,"email":121},"Jacob Szeszulski, PhD",{"name":145,"role":119,"phone":124,"phoneExt":87,"email":125},"Alexander MacMillan Uribe, PhD",{"type":147,"investigatorFullName":87,"investigatorTitle":87,"investigatorAffiliation":87,"oldNameTitle":87,"oldOrganization":87},"SPONSOR",[149],{"name":150,"class":151},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100505903",false,"NCT05867433","Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments","School Inclusion Criteria:\n\n* \\> 50 6th and 7th grade students\n* \\> 40% economically disadvantaged students\n* \\> 40% Black and Hispanic students\n\nSchool Exclusion Criteria:\n\nStudent Inclusion Criteria:\n\n* 6th or 7th grade student\n* Attend a Title 1 middle school that is participating in the STHS intervention\n* Read and understand English\n\nStudent Exclusion Criteria:\n\n* Participation in a weight loss program in the past 3 months\n* Presence of a condition that prevents participation in physical activity",true,"ALL","8 Years",{"count":161,"type":162},500,"ESTIMATED","INTERVENTIONAL",[165],"NA","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.",[168,169,170],"Cardiovascular Diseases","Nutrition","Physical Activity","2025-09-05",{"date":173,"type":174},"2025-09-12","ACTUAL",{"date":176,"type":174},"2023-09-27",{"date":178,"type":162},"2027-04-15",{"name":5,"class":6},1]