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The HIIT Cognition Study

Not Applicable
Completed
Conditions
High Intensity Interval Training
Cognition
Overweight and Obesity
Metabolic Disease
Interventions
Behavioral: HIIT Exercise Intervention
Behavioral: Stretching Intervention
Registration Number
NCT05137990
Lead Sponsor
University of Southern California
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HIIT Exercise InterventionHIIT Exercise InterventionAt 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.
Stretching InterventionStretching InterventionAt 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.
Primary Outcome Measures
NameTimeMethod
Profile of Mood States for Adolescents14 weeks

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

Self-Efficacy for Physical Activity Scale14 weeks

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

Physical Activity Enjoyment Scale14 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

Blood Pressure14 weeks

systolic and diastolic blood pressure

Measures of intervention feasibility14 weeks

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 efficacy14 weeks

percent of sessions where youth achieve their target heart rate

Intervention Feasibility Measure14 weeks

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

Intervention Appropriateness Measure14 weeks

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

Cognitive function measures14 weeks

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

Glucose Sensitivity14 weeks

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

Intervention Acceptability Measure14 weeks

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

Vascular Endothelial-Derived Growth14 weeks

vascular endothelial growth factor (VEGF) in pg/mL

Positive and Negative Affect Scale for Children14 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

State-Trait Anxiety Inventory for Children14 weeks

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

Perceived Stress Scale14 weeks

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 Scale14 weeks

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

Markers of inflammation14 weeks

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

Cardiorespiratory Fitness14 weeks

maximal oxygen consumption (VO2max)

Body proportion14 weeks

waist-to-height ratio

Body composition14 weeks

percent body fat

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Southern California

🇺🇸

Los Angeles, California, United States

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