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The HIIT Cognition Study

Primary Purpose

High Intensity Interval Training, Overweight and Obesity, Metabolic Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIIT Exercise Intervention
Stretching Intervention
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for High Intensity Interval Training focused on measuring High Intensity Interval Training, Physical Activity, Pediatric Obesity, Metabolic Disturbances, Mental Health

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HIIT Exercise Intervention

Stretching Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Measures of intervention efficacy
percent of sessions where youth achieve their target heart rate
Intervention Feasibility Measure
4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility
Intervention Acceptability Measure
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability
Intervention Appropriateness Measure
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness
Cognitive function measures
executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores
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
Profile of Mood States for Adolescents
24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome
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
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
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
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
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
Glucose Sensitivity
glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)
Markers of inflammation
interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL
Vascular Endothelial-Derived Growth
vascular endothelial growth factor (VEGF) in pg/mL
Cardiorespiratory Fitness
maximal oxygen consumption (VO2max)
Blood Pressure
systolic and diastolic blood pressure
Body proportion
waist-to-height ratio
Body composition
percent body fat

Secondary Outcome Measures

Full Information

First Posted
October 6, 2021
Last Updated
February 27, 2023
Sponsor
University of Southern California
Collaborators
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05137990
Brief Title
The HIIT Cognition Study
Official Title
The Effects of High Intensity Exercise in Teens on Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Intensity Interval Training, Overweight and Obesity, Metabolic Disease, Cognition
Keywords
High Intensity Interval Training, Physical Activity, Pediatric Obesity, Metabolic Disturbances, Mental Health

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIT Exercise Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching Intervention
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIIT Exercise Intervention
Other Intervention Name(s)
Exercise group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stretching Intervention
Other Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measures of intervention feasibility
Description
percent of youth who complete an average of 70% of weekly minutes and percent of youth who attend 70% of exercise sessions
Time Frame
14 weeks
Title
Measures of intervention efficacy
Description
percent of sessions where youth achieve their target heart rate
Time Frame
14 weeks
Title
Intervention Feasibility Measure
Description
4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility
Time Frame
14 weeks
Title
Intervention Acceptability Measure
Description
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability
Time Frame
14 weeks
Title
Intervention Appropriateness Measure
Description
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness
Time Frame
14 weeks
Title
Cognitive function measures
Description
executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores
Time Frame
14 weeks
Title
Positive and Negative Affect Scale for Children
Description
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
Time Frame
14 weeks
Title
Profile of Mood States for Adolescents
Description
24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome
Time Frame
14 weeks
Title
State-Trait Anxiety Inventory for Children
Description
20-item scale measuring acute and long-term anxiety, with a range from 20 to 80; higher scores indicate more anxiety
Time Frame
14 weeks
Title
Perceived Stress Scale
Description
10-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items
Time Frame
14 weeks
Title
Stress in Children Scale
Description
21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items
Time Frame
14 weeks
Title
Self-Efficacy for Physical Activity Scale
Description
5-item scale with each ranging from 1 to 5; higher scores indicating a better self-efficacy for physical activity outcome
Time Frame
14 weeks
Title
Physical Activity Enjoyment Scale
Description
18-item scale with each ranging from 1 to 7; higher scores indicate a better physical activity enjoyment outcome after reverse coding applicable items
Time Frame
14 weeks
Title
Glucose Sensitivity
Description
glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)
Time Frame
14 weeks
Title
Markers of inflammation
Description
interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL
Time Frame
14 weeks
Title
Vascular Endothelial-Derived Growth
Description
vascular endothelial growth factor (VEGF) in pg/mL
Time Frame
14 weeks
Title
Cardiorespiratory Fitness
Description
maximal oxygen consumption (VO2max)
Time Frame
14 weeks
Title
Blood Pressure
Description
systolic and diastolic blood pressure
Time Frame
14 weeks
Title
Body proportion
Description
waist-to-height ratio
Time Frame
14 weeks
Title
Body composition
Description
percent body fat
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Britni R. Belcher, PhD
Phone
323 442 8225
Email
bbelcher@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen A. Page, MD
Phone
323 442 2806
Email
katie.page@usc.edu
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britni R. Belcher, PhD
Phone
323-442-8225
Email
bbelcher@usc.edu
First Name & Middle Initial & Last Name & Degree
Kathleen A. Page, MD
Phone
323 442 2806
Email
katie.page@usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not intend to share IPD with other researchers outside of our study.

Learn more about this trial

The HIIT Cognition Study

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