Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Presence or absence of metabolic syndrome (MetS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •School Inclusion Criteria:
- •> 50 6th and 7th grade students
- •> 40% economically disadvantaged students
- •> 40% Black and Hispanic students
排除标准
- •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
研究组 & 干预措施
STHS Intervention
Participants in this group (10 schools) will participate in the STHS program.
干预措施: STHS Intervention (Behavioral)
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.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Presence or absence of metabolic syndrome (MetS)
时间窗: 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
Change in the number of MetS risk factors
时间窗: 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
Positive Youth Development score
时间窗: 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)
次要结局
- Concentration of serum triglycerides(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Waist circumference(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Height(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Concentration of HDL cholesterol(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Blood pressure level(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Accelerometer-derived physical activity estimation(Baseline to 9 months)
- Concentration of blood glucose(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Assessment of perceptions of school environments and school-specific dietary intake patterns(Baseline to 9 months)
- Assessment of participatory competence and decision-making(Baseline to 9 months)
- Peer concentration of subdermal carotenoids(Baseline to 9 months)
- Concentration of subdermal carotenoids(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Assessment of advocacy outcome efficacy(Baseline to 9 months)
- Weight(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Physical fitness capacity estimation(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Body mass index (BMI)(Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention)
- Sedentary time(Baseline to 9 months)
- Time spent sleeping(Baseline to 9 months)
- School physical activity and nutrition environment assessment(Baseline to 9 months)
- Assessment of perceived sociopolitical control(Baseline to 9 months)
- Assessment of assertiveness(Baseline to 9 months)
- Peer Body mass index (BMI)(Baseline to 9 months)
- Peer physical fitness capacity estimation(Baseline to 9 months)