The HIIT Cognition Study

NCT05137990 | Completed

• 1 other identifier: HS-21-00149
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

High Intensity Interval Training; Overweight and Obesity; Metabolic Disease; Cognition

Keywords

High Intensity Interval Training; Physical Activity; Pediatric Obesity; Metabolic Disturbances; Mental Health

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (2)

HIIT Exercise Intervention

EXPERIMENTAL

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

Stretching Intervention

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Exercise group

HIIT Exercise Intervention

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.

Also known as: Control group

Stretching Intervention

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Diseases; Motor Activity; Pediatric Obesity; Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 30, 2021
• Study Start: March 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)