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健全な学校のために強い十代の若者がクラブを変える:身体活動と健康的な食事環境を改善するための市民参加のアプローチ

2026年9月29日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

500

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

8年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

他の: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Presence or absence of metabolic syndrome (MetS)
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Blood pressure level
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠:Baseline to 9 months

Sedentary time will be measured using Actigraph accelerometers.

Baseline to 9 months
Time spent sleeping
時間枠:Baseline to 9 months

Sleep time will be measured using Actigraph accelerometers.

Baseline to 9 months
Physical fitness capacity estimation
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年9月27日

一次修了 (推定)

2027年4月15日

研究の完了 (推定)

2027年4月15日

試験登録日

最初に提出

2023年4月11日

QC基準を満たした最初の提出物

2023年5月10日

最初の投稿 (実際)

2023年5月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月5日

QC基準を満たした最後の更新が送信されました

2026年9月29日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB2022-1159D
  • R01MD018214 (米国 NIH グラント/契約)

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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