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Completed

NCT Number: NCT05137990

The HIIT Cognition Study

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.

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Key information

Conditions

High Intensity Interval Training Behavior Body Weight Cognition Metabolic Disease Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Pediatric Obesity Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT Exercise Intervention

Behavioral

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.

Other names: Exercise group

Stretching Intervention

Behavioral

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.

Other names: Control group

Primary outcomes

  1. Measures of intervention feasibility

    Time frame: 14 weeks

    percent of youth who complete an average of 70% of weekly minutes and percent of youth who attend 70% of exercise sessions

  2. Measures of intervention efficacy

    Time frame: 14 weeks

    percent of sessions where youth achieve their target heart rate

  3. Intervention Feasibility Measure

    Time frame: 14 weeks

    4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility

  4. Intervention Acceptability Measure

    Time frame: 14 weeks

    4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability

  5. Intervention Appropriateness Measure

    Time frame: 14 weeks

    4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness

  6. Cognitive function measures

    Time frame: 14 weeks

    executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores

  7. Positive and Negative Affect Scale for Children

    Time frame: 14 weeks

    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

  8. Profile of Mood States for Adolescents

    Time frame: 14 weeks

    24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome

  9. State-Trait Anxiety Inventory for Children

    Time frame: 14 weeks

    20-item scale measuring acute and long-term anxiety, with a range from 20 to 80; higher scores indicate more anxiety

  10. Perceived Stress Scale

    Time frame: 14 weeks

    10-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items

  11. Stress in Children Scale

    Time frame: 14 weeks

    21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items

  12. Self-Efficacy for Physical Activity Scale

    Time frame: 14 weeks

    5-item scale with each ranging from 1 to 5; higher scores indicating a better self-efficacy for physical activity outcome

  13. Physical Activity Enjoyment Scale

    Time frame: 14 weeks

    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. Glucose Sensitivity

    Time frame: 14 weeks

    glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)

  15. Markers of inflammation

    Time frame: 14 weeks

    interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL

  16. Vascular Endothelial-Derived Growth

    Time frame: 14 weeks

    vascular endothelial growth factor (VEGF) in pg/mL

  17. Cardiorespiratory Fitness

    Time frame: 14 weeks

    maximal oxygen consumption (VO2max)

  18. Blood Pressure

    Time frame: 14 weeks

    systolic and diastolic blood pressure

  19. Body proportion

    Time frame: 14 weeks

    waist-to-height ratio

  20. Body composition

    Time frame: 14 weeks

    percent body fat

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Dana-Farber Cancer Institute

Registry information

Official study title

The Effects of High Intensity Exercise in Teens on Cognition

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2021
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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