Overweight and Obesity Clinical Trial
Official title:
The Effects of High Intensity Exercise in Teens on Cognition
Verified date | May 2024 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. All participants (N=24) will complete screening via phone to determine eligibility. Eligible participants will be randomized to receive a) 14 weeks of a home-based HIIT intervention delivered via iPad or b) 14 weeks of a stretching intervention (control group). Each participant will undergo an in-lab pre- and post-test visit, where they will complete a fasting blood draw, a fitness test, and various cognitive and mental health measures.
Status | Completed |
Enrollment | 6 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. Typically developing youth. 2. Overweight/obese (BMI >= 85th percentile) 3. Does not meet current PA guidelines 4. Able and willing to complete HIIT exercise intervention. 5. Space for a stationary bike in the residence. Exclusion Criteria: 1. Diagnoses of neurodevelopment or psychiatric disorders. 2. Diabetes, cardiovascular, pulmonary, or other significant medical problems. 3. Taking medications know to alter metabolism. 4. Allergy to metals. 5. Inability to participate in HIIT-based exercise or active involvement in sports/exercise programs. 6. Pregnancy. |
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measures of intervention feasibility | percent of youth who complete an average of 70% of weekly minutes and percent of youth who attend 70% of exercise sessions | 14 weeks | |
Primary | Measures of intervention efficacy | percent of sessions where youth achieve their target heart rate | 14 weeks | |
Primary | Intervention Feasibility Measure | 4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility | 14 weeks | |
Primary | Intervention Acceptability Measure | 4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability | 14 weeks | |
Primary | Intervention Appropriateness Measure | 4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness | 14 weeks | |
Primary | Cognitive function measures | executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores | 14 weeks | |
Primary | Positive and Negative Affect Scale for Children | 10-item positive and negative affect scale with scores for each ranging from 0 to 5; higher scores indicate a worse outcome for negative affect and better outcome for positive affect | 14 weeks | |
Primary | Profile of Mood States for Adolescents | 24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome | 14 weeks | |
Primary | State-Trait Anxiety Inventory for Children | 20-item scale measuring acute and long-term anxiety, with a range from 20 to 80; higher scores indicate more anxiety | 14 weeks | |
Primary | Perceived Stress Scale | 10-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items | 14 weeks | |
Primary | Stress in Children Scale | 21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items | 14 weeks | |
Primary | Self-Efficacy for Physical Activity Scale | 5-item scale with each ranging from 1 to 5; higher scores indicating a better self-efficacy for physical activity outcome | 14 weeks | |
Primary | Physical Activity Enjoyment Scale | 18-item scale with each ranging from 1 to 7; higher scores indicate a better physical activity enjoyment outcome after reverse coding applicable items | 14 weeks | |
Primary | Glucose Sensitivity | glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance) | 14 weeks | |
Primary | Markers of inflammation | interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL | 14 weeks | |
Primary | Vascular Endothelial-Derived Growth | vascular endothelial growth factor (VEGF) in pg/mL | 14 weeks | |
Primary | Cardiorespiratory Fitness | maximal oxygen consumption (VO2max) | 14 weeks | |
Primary | Blood Pressure | systolic and diastolic blood pressure | 14 weeks | |
Primary | Body proportion | waist-to-height ratio | 14 weeks | |
Primary | Body composition | percent body fat | 14 weeks |
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