NCT05029388

Brief Summary

The increasing rate of mental health issues among adolescents has recently been a considerable concern in Hong Kong. In particular, adolescents with low socioeconomic status (SES) are likely to experience poor mental health including low self-esteem and high levels of anxiety, anger, and depression. Previous research has found that physical activities have a positive impact on improving mental health outcomes among adolescents. However, approximately 96% of adolescents in Hong Kong fail to engage in regular exercises, which potentially increase risk of poor mental health. This study aims to (1) examine whether changes in the three indicators (reduced ill-being, enhanced well-being and cognitive functions) of mental health among adolescents with low socioeconomic status are evident before and after exercises. In addition, this study (2) compares the effectiveness of aerobic exercise and high-intensity interval training in these indicators among adolescents with low SES. A range of neuropsychological tests and psychometric scales will be used to measure the executive functions and indicators of psychological well-being and ill-being, which include enjoyment, self-efficacy, mood, depression, anxiety, and stress. It is hoped that the findings will help inform policymakers and practitioners for promoting the importance of physical exercises to enhance mental health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

August 16, 2021

Last Update Submit

August 19, 2024

Conditions

Keywords

adolescentsmental healthexercisesocioeconomic statusintervention

Outcome Measures

Primary Outcomes (32)

  • Physical Activity Enjoyment Scale (S-PACES)

    This scale will be utilized to measure enjoyment. The S-PACES includes seven negatively worded items (e.g., "It is not at all interesting"), anchored on a five-point Likert scale that ranges from 1 (disagree a lot) to 5 (agree a lot).

    One week before pretest

  • Physical Activity Enjoyment Scale (S-PACES)

    This scale will be utilized to measure enjoyment. The S-PACES includes seven negatively worded items (e.g., "It is not at all interesting"), anchored on a five-point Likert scale that ranges from 1 (disagree a lot) to 5 (agree a lot).

    10 weeks after intervention

  • Physical Activity Enjoyment Scale (S-PACES)

    This scale will be utilized to measure enjoyment. The S-PACES includes seven negatively worded items (e.g., "It is not at all interesting"), anchored on a five-point Likert scale that ranges from 1 (disagree a lot) to 5 (agree a lot).

    3 months after intervention

  • General Self-Efficacy Scale (GSES)

    This scale will be administered to measure the adolescents' self-efficacy. The GSES contains 10 items (e.g., "I can constantly manage to solve difficult problems if I try hard enough"), with responses ranging from 1 (not at all true) to 4 (exactly true).

    One week before pretest

  • General Self-Efficacy Scale (GSES)

    This scale will be administered to measure the adolescents' self-efficacy. The GSES contains 10 items (e.g., "I can constantly manage to solve difficult problems if I try hard enough"), with responses ranging from 1 (not at all true) to 4 (exactly true).

    10 weeks after intervention

  • General Self-Efficacy Scale (GSES)

    This scale will be administered to measure the adolescents' self-efficacy. The GSES contains 10 items (e.g., "I can constantly manage to solve difficult problems if I try hard enough"), with responses ranging from 1 (not at all true) to 4 (exactly true).

    3 months after intervention

  • Satisfaction with Life Scale (SWLS)

    The scale will be used to measure life satisfaction. This scale is a short five-item (e.g., "I am satisfied with my life") scale based on a seven-point rating scale that ranges from 1 (strongly disagree) to 7 (strongly agree).

    One week before pretest

  • Satisfaction with Life Scale (SWLS)

    The scale will be used to measure life satisfaction. This scale is a short five-item (e.g., "I am satisfied with my life") scale based on a seven-point rating scale that ranges from 1 (strongly disagree) to 7 (strongly agree).

    10 weeks after intervention

  • Satisfaction with Life Scale (SWLS)

    The scale will be used to measure life satisfaction. This scale is a short five-item (e.g., "I am satisfied with my life") scale based on a seven-point rating scale that ranges from 1 (strongly disagree) to 7 (strongly agree).

    3 months after intervention

  • 21-item Depression Anxiety Stress Scale (DASS-21)

    The DASS-21 scale will be used to measure depression (e.g., "I felt that I lack something to look forward to"), anxiety (e.g., "I felt that I was close to panic"), and stress (e.g., "I found it difficult to relax") among adolescents. The respondents will be asked to rate the items through a four-point combined severity/frequency scale that ranges from 0 (not applicable to me at all) to 3 (extremely applicable to me) based on their experiences that are related to each item over the past week.

    One week before pretest

  • 21-item Depression Anxiety Stress Scale (DASS-21)

    The DASS-21 scale will be used to measure depression (e.g., "I felt that I lack something to look forward to"), anxiety (e.g., "I felt that I was close to panic"), and stress (e.g., "I found it difficult to relax") among adolescents. The respondents will be asked to rate the items through a four-point combined severity/frequency scale that ranges from 0 (not applicable to me at all) to 3 (extremely applicable to me) based on their experiences that are related to each item over the past week.

    10 weeks after intervention

  • 21-item Depression Anxiety Stress Scale (DASS-21)

    The DASS-21 scale will be used to measure depression (e.g., "I felt that I lack something to look forward to"), anxiety (e.g., "I felt that I was close to panic"), and stress (e.g., "I found it difficult to relax") among adolescents. The respondents will be asked to rate the items through a four-point combined severity/frequency scale that ranges from 0 (not applicable to me at all) to 3 (extremely applicable to me) based on their experiences that are related to each item over the past week.

    3 months after intervention

  • Brunel Mood Scale (BRUMS-C)

    The BRUMS-C will be created based on the work of Terry, Lane, Lane, and Keohane (1999) to assess the mood among Chinese students and adults. The BRUMS-C is a 23-item inventory with five negative mood dimensions, namely, anger, confusion, depression, fatigue, and tension. Respondents will be asked to indicate their feelings (e.g., angry, unhappy, or nervous) through a five-point Likert scale that ranges from 0 (not at all) to 4 (extremely).

    One week before pretest

  • Brunel Mood Scale (BRUMS-C)

    The BRUMS-C will be created based on the work of Terry, Lane, Lane, and Keohane (1999) to assess the mood among Chinese students and adults. The BRUMS-C is a 23-item inventory with five negative mood dimensions, namely, anger, confusion, depression, fatigue, and tension. Respondents will be asked to indicate their feelings (e.g., angry, unhappy, or nervous) through a five-point Likert scale that ranges from 0 (not at all) to 4 (extremely).

    10 weeks after intervention

  • Brunel Mood Scale (BRUMS-C)

    The BRUMS-C will be created based on the work of Terry, Lane, Lane, and Keohane (1999) to assess the mood among Chinese students and adults. The BRUMS-C is a 23-item inventory with five negative mood dimensions, namely, anger, confusion, depression, fatigue, and tension. Respondents will be asked to indicate their feelings (e.g., angry, unhappy, or nervous) through a five-point Likert scale that ranges from 0 (not at all) to 4 (extremely).

    3 months after intervention

  • Blood Pressure

    Blood pressure will be measured with an automated blood pressure monitoring device. The participants will be given 10-minute rest before the measurement. The systolic and diastolic blood pressure will be measured thrice, with a one-minute interval between readings. If the blood pressure differed by more than 5 mm Hg, then additional readings will be obtained. A mean of the three consecutive readings will be used as the examination value. The unit of measurement for blood pressure is mmHg.

    Resting state at baseline

  • Blood Pressure

    Blood pressure will be measured with an automated blood pressure monitoring device. The participants will be given 10-minute rest before the measurement. The systolic and diastolic blood pressure will be measured thrice, with a one-minute interval between readings. If the blood pressure differed by more than 5 mm Hg, then additional readings will be obtained. A mean of the three consecutive readings will be used as the examination value. The unit of measurement for blood pressure is mmHg.

    At the end of training

  • Resting Heart Rate

    The resting heart rate will be measured through a wireless heart rate monitor that will be worn by the participants (Polar Electro OY, Finland) for one minute after their 10-minute rest. The unit of measurement for heart rate is bpm (beats per minute).

    Resting state at baseline

  • Resting Heart Rate

    The resting heart rate will be measured through a wireless heart rate monitor that will be worn by the participants (Polar Electro OY, Finland) for one minute after their 10-minute rest. The unit of measurement for heart rate is bpm (beats per minute).

    At the end of training

  • Body Mass Index

    The body weight and height will be measured using an electronic digital scale and a stadiometer, respectively. The body mass index (BMI) will be calculated by dividing body weight (kg) by height (m\^2).

    Resting state at baseline

  • Body Mass Index

    The body weight and height will be measured using an electronic digital scale and a stadiometer, respectively. The body mass index (BMI) will be calculated by dividing body weight (kg) by height (m\^2).

    At the end of training

  • Waist-to-Hip Ratio

    The waist circumference and hip circumference will be measured twice using an anthropometric tape while the participants stand erect and relaxed with their arms at their sides and feet positioned close together. The waist circumference will be measured between the upper border of the iliac crest and the lowest border of the rib cage at the end of normal expiration. The hip circumference will be measured at the widest part of the hip at the level of the greatest trochanter. The tape will be positioned at a level that is parallel to the floor. The unit of measure will be in centimeters (cm) to the nearest 0.1 cm. The waist-to-hip ratio will be calculated as the ratio of the waist-to-hip circumference.

    Resting state at baseline

  • Waist-to-Hip Ratio

    The waist circumference and hip circumference will be measured twice using an anthropometric tape while the participants stand erect and relaxed with their arms at their sides and feet positioned close together. The waist circumference will be measured between the upper border of the iliac crest and the lowest border of the rib cage at the end of normal expiration. The hip circumference will be measured at the widest part of the hip at the level of the greatest trochanter. The tape will be positioned at a level that is parallel to the floor. The unit of measure will be in centimeters (cm) to the nearest 0.1 cm. The waist-to-hip ratio will be calculated as the ratio of the waist-to-hip circumference.

    At the end of training

  • Stroop Color-Word Test

    Inhibition will be measured using the non-computerized Stroop Color and Word Test (under the word condition, color condition, and color-word condition in three separate 1-minute rounds. In the word condition (W), participants are instructed to read the Chinese words and name the Chinese colors printed in black. In the color condition (C), participants are required to name the colors of printed patches. Finally, in the color-word condition (CW), the name of a color (e.g., BLUE) is presented using either a congruent color (e.g., blue) or an incongruent color (e.g., yellow) in Chinese. Participants have to name the color, instead of reading the word as quickly and accurately as possible.

    One week before pretest

  • Stroop Color-Word Test

    Inhibition will be measured using the non-computerized Stroop Color and Word Test (under the word condition, color condition, and color-word condition in three separate 1-minute rounds. In the word condition (W), participants are instructed to read the Chinese words and name the Chinese colors printed in black. In the color condition (C), participants are required to name the colors of printed patches. Finally, in the color-word condition (CW), the name of a color (e.g., BLUE) is presented using either a congruent color (e.g., blue) or an incongruent color (e.g., yellow) in Chinese. Participants have to name the color, instead of reading the word as quickly and accurately as possible.

    10 weeks after intervention

  • Stroop Color-Word Test

    Inhibition will be measured using the non-computerized Stroop Color and Word Test (under the word condition, color condition, and color-word condition in three separate 1-minute rounds. In the word condition (W), participants are instructed to read the Chinese words and name the Chinese colors printed in black. In the color condition (C), participants are required to name the colors of printed patches. Finally, in the color-word condition (CW), the name of a color (e.g., BLUE) is presented using either a congruent color (e.g., blue) or an incongruent color (e.g., yellow) in Chinese. Participants have to name the color, instead of reading the word as quickly and accurately as possible.

    3 months after intervention

  • Digit Span Test

    Working memory will be measured using the Backward Digit Span subtest of the Wechsler Intelligence Scale for Children, Third Edition \[WISC-III\]. Participants are orally presented with 18 sequences of single-digit numbers of increasing length, from two to nine (two sequences per length), and must repeat the numbers in backwards order. One point is given for each completely recalled sequence, and the test is terminated after two consecutive unsuccessful recalls.

    One week before pretest

  • Digit Span Test

    Working memory will be measured using the Backward Digit Span subtest of the Wechsler Intelligence Scale for Children, Third Edition \[WISC-III\]. Participants are orally presented with 18 sequences of single-digit numbers of increasing length, from two to nine (two sequences per length), and must repeat the numbers in backwards order. One point is given for each completely recalled sequence, and the test is terminated after two consecutive unsuccessful recalls.

    10 weeks after intervention

  • Digit Span Test

    Working memory will be measured using the Backward Digit Span subtest of the Wechsler Intelligence Scale for Children, Third Edition \[WISC-III\]. Participants are orally presented with 18 sequences of single-digit numbers of increasing length, from two to nine (two sequences per length), and must repeat the numbers in backwards order. One point is given for each completely recalled sequence, and the test is terminated after two consecutive unsuccessful recalls.

    3 months after intervention

  • Wisconsin Card Sorting Test

    The Wisconsin Card Sorting Test will be administered with Inquisit 6 by Millisecond Software to measure cognitive flexibility. Participants are presented with four stimulus cards and a deck of response cards that vary in three dimensions (i.e., color, shape, and number). They are asked to match a fifth card from the sequentially presented response cards to one of the four key cards. The rules that underpin the classification are matching by color, shape, or number. Participants need to follow the correct card classification rule in accordance with the feedback they receive after each trial. After participants correctly respond to ten consecutive trials, the classification rule changes, requiring flexible set-shifting.

    One week before pretest

  • Wisconsin Card Sorting Test

    The Wisconsin Card Sorting Test will be administered with Inquisit 6 by Millisecond Software to measure cognitive flexibility. Participants are presented with four stimulus cards and a deck of response cards that vary in three dimensions (i.e., color, shape, and number). They are asked to match a fifth card from the sequentially presented response cards to one of the four key cards. The rules that underpin the classification are matching by color, shape, or number. Participants need to follow the correct card classification rule in accordance with the feedback they receive after each trial. After participants correctly respond to ten consecutive trials, the classification rule changes, requiring flexible set-shifting.

    10 weeks after intervention

  • Wisconsin Card Sorting Test

    The Wisconsin Card Sorting Test will be administered with Inquisit 6 by Millisecond Software to measure cognitive flexibility. Participants are presented with four stimulus cards and a deck of response cards that vary in three dimensions (i.e., color, shape, and number). They are asked to match a fifth card from the sequentially presented response cards to one of the four key cards. The rules that underpin the classification are matching by color, shape, or number. Participants need to follow the correct card classification rule in accordance with the feedback they receive after each trial. After participants correctly respond to ten consecutive trials, the classification rule changes, requiring flexible set-shifting.

    3 months after intervention

Study Arms (3)

Aerobic Exercise

EXPERIMENTAL

This experimental group will receive aerobic exericse. This group will be led by a certified personal trainer with at least three years of experience in guiding adolescents in group exercises. The aerobic exercise training will be conducted in the fitness room of a local sports center that is hosted by the Leisure and Cultural Services Department in Hong Kong.

Other: Aerobic Exercise

High Intensity Interval Training

EXPERIMENTAL

This experimental group will receive high intensity interval training. This group will be led by a certified personal trainer with at least three years of experience in guiding adolescents in group exercises. The HIIT training will be conducted in the fitness room of a local sports center that is hosted by the Leisure and Cultural Services Department in Hong Kong.

Other: High Intensity Interval Training

Control Group

NO INTERVENTION

This group will not take part in aerobic exercise and HIIT training programme. Participants will be given an exercise diary or logbook to keep track of their exercise habits (i.e., record the type of exercise/activity, hours, and intensity of exercise/activity every day) throughout the intervention periods.

Interventions

The participants will complete three training sessions per week over 10 weeks. The aerobic training program will last for one hour. The session will include a 10-minute warm-up period, followed by a 45-minute aerobic workout, wherein the participants can choose to use either a treadmill, a cycle ergometer, or a rowing ergometer. After the workout, a five-minute period of stretching will be provided for cooling down. The intensity during the workout will be set at 40%-55% of the individual's maximum heart rate.

Aerobic Exercise

The intervention will be conducted over a period of 10 weeks, while the participants will complete three training sessions per week. The HIIT training program will last for 30 minutes. The session will include a 10-minute warm-up period, followed by a 15-minute HIIT workout, and a 5-minute period of stretching to cool down. The exercises will include repeated, high-intensity intermittent bursts of vigorous activity at maximal effort. The HIIT will mainly include bodyweight exercises (e.g., push-ups, squats, lunges) that disregards equipment usage. The intensity during the workout will be set to 85%-95% of the individual's maximum heart rate. A half-day training workshop will be provided to the personal trainer to ensure that he/she knows the exercises and can demonstrate them to the participants.

High Intensity Interval Training

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Studying in secondary grades one to three
  • Between 12 and 15 years old
  • Belongs to a family with a household income below half of the median household income reported in HK, which was adjusted by household size

You may not qualify if:

  • Hypertension or diabetes mellitus without control
  • A history of brain injury and other neurological disease, epilepsy, or myocardial infarction
  • Musculoskeletal disease
  • Use medication that affects heart rate (e.g., beta-blockers, asthma medications, stimulants, digoxin, antiarrhythmic agents)
  • Cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Education University of Hong Kong

Tai Po, Hong Kong

Location

Related Publications (1)

  • Poon K. Effects of Aerobic Exercise and High-Intensity Interval Training on the Mental Health of Adolescents Living in Poverty: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jan 17;11(1):e34915. doi: 10.2196/34915.

MeSH Terms

Conditions

Psychological Well-BeingMotor Activity

Interventions

ExerciseHigh-Intensity Interval Training

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A total of 78 participants with low SES who are aged between 12 and 15 and studying in secondary one to three from local secondary schools will be recruited for this study. They will be randomly assigned to either an aerobic exercise group, an HIIT group, or a no-exercise control group. Participants in the first two groups will partake in a 10-week training program period, which will be conducted thrice a week on non-consecutive days.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 31, 2021

Study Start

October 3, 2022

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations