Clinical trial NCT05867433: Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
Official title: Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Nutrition
Physical Activity
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-05-22
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: School-based cluster randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence or absence of metabolic syndrome (MetS)
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Change in the number of MetS risk factors
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Positive Youth Development score
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary outcomes:
measure: Blood pressure level
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Concentration of blood glucose
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Waist circumference
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Concentration of HDL cholesterol
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Concentration of serum triglycerides
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Height
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Weight
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Body mass index (BMI)
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Concentration of subdermal carotenoids
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: Accelerometer-derived physical activity estimation
timeFrame: Baseline to 9 months
measure: Sedentary time
timeFrame: Baseline to 9 months
measure: Time spent sleeping
timeFrame: Baseline to 9 months
measure: Physical fitness capacity estimation
timeFrame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
measure: School physical activity and nutrition environment assessment
timeFrame: Baseline to 9 months
measure: Assessment of perceptions of school environments and school-specific dietary intake patterns
timeFrame: Baseline to 9 months
measure: Assessment of perceived sociopolitical control
timeFrame: Baseline to 9 months
measure: Assessment of assertiveness
timeFrame: Baseline to 9 months
measure: Assessment of participatory competence and decision-making
timeFrame: Baseline to 9 months
measure: Assessment of advocacy outcome efficacy
timeFrame: Baseline to 9 months
measure: Peer concentration of subdermal carotenoids
timeFrame: Baseline to 9 months
measure: Peer Body mass index (BMI)
timeFrame: Baseline to 9 months
measure: Peer physical fitness capacity estimation
timeFrame: Baseline to 9 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M AgriLife Dallas Center
state: Texas
Study officials:
References: