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Clinical Trials/NCT05867433
NCT05867433RecruitingNot Applicable

Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments

Texas A&M University2 sites in 1 country500 target enrollmentStarted: September 27, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
500
Locations
2
Primary Endpoint
Presence or absence of metabolic syndrome (MetS)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
8 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • > 50 6th and 7th grade students
  • > 40% economically disadvantaged students
  • > 40% Black and Hispanic students

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

Outcomes

Primary Outcomes

Presence or absence of metabolic syndrome (MetS)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Secondary Outcomes

  • 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)
  • Concentration of serum triglycerides(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)
  • Waist circumference(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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