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건강한 학교를 위한 강한 십대 클럽 변경: 신체 활동 및 건강한 식습관 개선을 위한 시민 참여 접근 방식

2026년 9월 29일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

500

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

8년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: STHS Intervention

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

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.

다른: 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.

No STHS program

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Presence or absence of metabolic syndrome (MetS)
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Blood pressure level
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: Baseline to 9 months

Sedentary time will be measured using Actigraph accelerometers.

Baseline to 9 months
Time spent sleeping
기간: Baseline to 9 months

Sleep time will be measured using Actigraph accelerometers.

Baseline to 9 months
Physical fitness capacity estimation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 9월 27일

기본 완료 (추정된)

2027년 4월 15일

연구 완료 (추정된)

2027년 4월 15일

연구 등록 날짜

최초 제출

2023년 4월 11일

QC 기준을 충족하는 최초 제출

2023년 5월 10일

처음 게시됨 (실제)

2023년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB2022-1159D
  • R01MD018214 (미국 NIH 보조금/계약)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다