The HIIT Cognition Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Rationale: Existing literature supports the premise that physical activity (PA) has beneficial effects on cognitive function in youth, but prior studies have limitations, such as cross-sectional designs with limited insights on the intensity or duration of PA or the biological underpinnings linking physical activity and mental health and cognitive function in adolescents. A limited number of studies (and none in the U.S.) have evaluated the effects of HIIT on cognitive processes in youth, particularly in youth with overweight/obesity whose age-related declines in PA puts them at increased risk for poor outcomes. This study is particularly timely during the current COVID-19 related public health crisis because our HIIT exercise intervention is time efficient, delivered remotely, and completed using space-efficient equipment in the home. Intervention: Participants (youth ages 12-16 years with overweight/obesity) will be randomly assigned to complete a) 14 weeks of a home-based virtual, interactive HIIT intervention or b) 14 weeks of a stretching intervention (control group). Objectives/Purpose: The overall goal is to improve cognitive and cardiometabolic outcomes in youth with overweight/obesity by implementing an at-home HIIT intervention. The aims of this study are: 1) to determine the feasibility, acceptability, and efficacy of HIIT in adolescents with overweight/obesity, 2) to examine the effectiveness of HIIT on cognitive and mental health outcomes, and 3) to examine the effectiveness of HIIT on cardiometabolic health. Study Population: This study will consist of youth ages 12-16 years with overweight/obesity (BMI >=85th percentile) who do not meet current PA guidelines. Study Methodology: 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 (HIIT group) or b) 14 weeks of a stretching intervention (control group). Those randomized to the HIIT group will receive the intervention 3 times/week and will be given a pre-assembled stationary bicycle to use to complete each exercise session, an iPad to Zoom with the exercise trainers, and a Fitbit to assess real-time heart rate. Exercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session. Those randomized to the control group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred. Study arms: Study participants will be randomly assigned to receive either the HIIT intervention (HIIT group) or receive the stretching intervention (control group). Endpoints/Outcomes: The primary cognitive and mental health endpoints are: executive function, episodic memory, working memory, affect, mood, anxiety, stress, self-efficacy for PA, and PA enjoyment. The primary cardiometabolic endpoints are: glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance), IL-6, IL-1, TNF-a, and VEGF. Statistical analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants.

Official Title
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The Effects of High Intensity Exercise in Teens on Cognition

Conditions
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High Intensity Interval Training, Overweight and Obesity, Metabolic Disease, Cognition

Intervention / Treatment
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* Behavioral: HIIT Exercise Intervention
* Behavioral: Stretching Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Typically developing youth. Overweight/obese (BMI >= 85th percentile) Does not meet current PA guidelines Able and willing to complete HIIT exercise intervention. Space for a stationary bike in the residence. Exclusion Criteria: Diagnoses of neurodevelopment or psychiatric disorders. Diabetes, cardiovascular, pulmonary, or other significant medical problems. Taking medications know to alter metabolism. Allergy to metals. Inability to participate in HIIT-based exercise or active involvement in sports/exercise programs. Pregnancy.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to complete one of two conditions: 1) 14 weeks of a home-based virtual HIIT exercise intervention or 2) 14 weeks of a stretching intervention (control group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIT Exercise Intervention<br>At home (N=12): Participants will complete an exercise session 3 times a week for 14 weeks. Each participant will receive a pre-assembled stationary bicycle to use to complete each session, an iPad to receive the intervention virtually from exercise trainers through Zoom, and a Fitbit to assess real-time heart rate. | Behavioral: HIIT Exercise Intervention<br>* Exercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session.<br>* Other names: Exercise group;|
| Placebo Comparator: Stretching Intervention<br>At home (N=12): Participants will complete a stretching protocol 3 times a week for 14 weeks. Participants will be asked to complete weekly records of flexibility compliance. | Behavioral: Stretching Intervention<br>* This group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred. To increase compliance and aid in the standardization of the home-based stretching, participants will be provided a booklet of the flexibility exercises. Participants will be shown how to use the booklet and instructed in the stretching exercises by an exercise trainer prior to the intervention.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Measures of intervention efficacy | percent of sessions where youth achieve their target heart rate | 14 weeks | 
| 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 | 
| 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 | 
| 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 | 
| Cognitive function measures | executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores | 14 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Glucose Sensitivity | glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance) | 14 weeks | 
| Markers of inflammation | interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL | 14 weeks | 
| Vascular Endothelial-Derived Growth | vascular endothelial growth factor (VEGF) in pg/mL | 14 weeks | 
| Cardiorespiratory Fitness | maximal oxygen consumption (VO2max) | 14 weeks | 
| Blood Pressure | systolic and diastolic blood pressure | 14 weeks | 
| Body proportion | waist-to-height ratio | 14 weeks | 
| Body composition | percent body fat | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Intensity Interval Training, Physical Activity, Pediatric Obesity, Metabolic Disturbances, Mental Health