search
Back to results

Effectiveness of High-intensity Interval Training (HIIT) Versus Moderate-intensity Continuous Training (MICT) in Reducing Visceral Fat in Adults With Central Obesity

Primary Purpose

Central Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Usual care control group
HIIT group
MICT group
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Obesity focused on measuring Central Obesity, Visceral Fat, HIIT, MICT

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults aged 18 - 60,
  2. Central obesity, defined as BMI ≥25 (obesity classification adopted by the Hong Kong Government) with waist circumference of ≥90 cm for men and ≥80 cm for women (abdominal obesity according to the International Diabetes Federation's Chinese ethnic-specific criterion),
  3. Males and females will be included to enhance generalizability.

Exclusion Criteria:

  1. ≥150 minutes moderate-intensity or ≥75 minutes vigorous-intensity exercise weekly,
  2. Regular HIIT or MICT (≥1 weekly) in the past 6 months,
  3. Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, etc.,
  4. Somatic conditions that limit exercise participation (e.g., limb loss),
  5. Impaired mobility due to chronic diseases (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal and autoimmune diseases),
  6. Daily smoking and drinking habit,
  7. Surgery, therapy or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, and dietitian-prescribed dietary program).

Sites / Locations

  • Li Ka Shing Faculty of Medicine, The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Usual care control group

HIIT group

MICT group

Arm Description

Subjects in the usual care control group will receive a health education program to provide the usual care information. This program will include 3-month biweekly sessions (70 minutes each session, total 6 sessions) for obesity-related health briefing, dietary caloric restriction advice, lifestyle counselling/consultation and stretching exercise.

A 3-month intervention of HIIT will be given to participants allocated to this group. The once-a-week HIIT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform brisk walking for four 4-min bouts at 85%-95% maximal heart rate (HRmax) with a 3-min active recovery walk at 50%-70% HRmax between each session. There will be a 5-min warm-up and cool-down in each exercise session. The duration of each exercise session will be 35 minutes. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor.

A 3-month intervention of MICT will be given to participants allocated to this group. The once-a-week MICT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform mild walking exercise for ~47 minutes at an intensity of 65-75% HRmax. This exercise volume matches the HIIT volume. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor.

Outcomes

Primary Outcome Measures

Visceral fat
The amounts of visceral fat (VAT) at the abdominal region will be assessed by a 1.5-Teala whole-body scanner. A breath-hold localizer scan will be performed prior to the MRI scan. T1-weighted in-phase images will be obtained by fast spoiled gradient-echo sequences during suspended end-expiration. The VAT and between the thoracic diaphragm and the upper broader of the first sacral vertebra will be manually marked on each transverse image to calculate the volume of abdominal VAT.

Secondary Outcome Measures

Subcutaneous fat
The amounts of subcutaneous fat (SAT) at the abdominal region will be assessed by a 1.5-Teala whole-body scanner. A breath-hold localizer scan will be performed prior to the MRI scan. T1-weighted in-phase images will be obtained by fast spoiled gradient-echo sequences during suspended end-expiration. The SAT between the thoracic diaphragm and the upper broader of the first sacral vertebra will be manually marked on each transverse image to calculate the volume of abdominal SAT.
Body fat mass
Total body fat mass will be determined using a full body dual-energy X-ray absorptiometry (DXA) scanner (Explorer S/N 91075, Hologic Inc., Waltham, USA). A trained technician who is blinded to the group allocation will perform the tests and analyze the results.
Body fat percentage
Total body fat percentage will be determined using a full body dual-energy X-ray absorptiometry (DXA) scanner (Explorer S/N 91075, Hologic Inc., Waltham, USA). A trained technician who is blinded to the group allocation will perform the tests and analyze the results.
Body Mass Index
BMI will be determined by the equation BMI (kg/m2) = bodyweight/height^2. A calibrated electronic balance(UC-321,A&D Weighing, Australia, 150 kg capacity, ± 0.05 kg accuracy) and a stadiometer (Seva 231, Seca, Germany, 205 cm limit, ± 0.05 cm accuracy; ) will be used for the measurements.
Waist Circumference 1
Waist circumference will be measured on bare skin midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm following the WHO guideline. Measurement will be performed at the end of normal expiration.
Waist Circumference 2
Waist circumference will be measured on bare skin following the National Institutes of Health (NIH) guideline method (the superior border of the iliac crest)using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm. Measurement will be performed at the end of normal expiration.
Cardiorespiratory fitness
A maximal exercise test adopting the modified Bruce protocol will be be conducted to determine the maximal oxygen uptake (VO2max) of the subjects. The test will be conducted on a calibrated motor-driven treadmill with continuous metabolic VO2 measurement using a COSMED Quark CPET gas analysis system.
Bone Mineral Density
Bone mineral density will be simultaneously determined during the DXA scan for total body fat mass.
Lean Mass
Lean mass will be simultaneously determined during the DXA scan for total body fat mass.
Health-related Quality of Life
The validated Chinese version 12-item short form survey measures health-related quality of life covering physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning. A higher overall score indicates better quality of life.
Adherence
Class attendance will be analysed to indicate adherence to the interventions.
Adverse Events
Adverse events will be closely monitored regularly by athletic coaches and research personnel, and by subjects' voluntary reports. Adverse events will be recorded as a secondary outcome.
Medication
Detailed information (e.g., drug name, type, dose and daily frequency) on the use of dyslipidemic and hypertensive medications will be recorded at baseline. Subjects altering the dosage of medications after consultation with their physician over the study period will also be recorded as a secondary outcome. The lowest recommended dose (LRD) for 7 days will be used for the analysis.
Habitual Physical Activity
Actigraph activity monitor (wGT3X-BT, Actigraph, USA) worn at the wrist region for 24 h over 7 consecutive days will be used to objectively determine habitual daily physical movement/activities.
Dietary Intake
Habitual dietary intake will be assessed by 3-day food diary using an electronic scale (KD-400, Tanita, Japan)to determine the daily caloric intake and the relative proportions of macronutrients (carbohydrate, fat, and protein).
Blood pressure
Blood pressure will be obtained at the same day with blood collection. Subjects will visit our laboratory in the morning after 10 hours of overnight fasting in order to retrain from consuming caffeine, alcohol, and blood pressure drugs at least 10 hours before the assessment. After 10 minutes of seated rest, blood pressure will be measured on the left arm using a sphygmomanometer. Systolic and diastolic blood pressure and mean arterial pressure will be obtained over the brachial artery region with the arm supported at the heart level using an appropriately sized cuff. Three measurements will be taken with a one-minute interval, and the average value will be recorded for analysis.
Hip circumference
Hip circumference will be be taken on bare skin around the widest portion of the buttocks using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm and the tape should be placed parallel to the floor.
Self-report habitual physical activity
Self-report habitual physical activity will be measured by International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher level of physical activity.
Enjoyment
Enjoyment towards exercise will be quantitatively measured by the Physical Activity Enjoyment Scale. This Chinese scale has an overall score from 18 to 126. While a higher score indicates higher level of enjoyment towards the exercise.

Full Information

First Posted
September 3, 2020
Last Updated
November 3, 2022
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04545320
Brief Title
Effectiveness of High-intensity Interval Training (HIIT) Versus Moderate-intensity Continuous Training (MICT) in Reducing Visceral Fat in Adults With Central Obesity
Official Title
Effectiveness of Once-a-week High-intensity Interval Training (HIIT) Versus Moderate-intensity Continuous Training (MICT) in Reducing Visceral Fat in Adults With Central Obesity, a Pilot Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled in this study due to the COVID-19 pandemic.
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

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

5. Study Description

Brief Summary
Obesity is a major risk factor for cardiovascular disease and diabetes as well as all-cause mortality. The prevalence of obesity has continuously increased in most countries and has doubled in over 70 countries since 1980. The World Health Organization (WHO) estimated in 2014 that ~600 million (13%) adults were obese and ~1.9 billion (39%) were overweight worldwide. Notably, United States and China have the highest numbers of obese adults. According to a national survey in China in 2014 conducted among 146,703 Chinese adults aged 20-59, the prevalence of obesity was 13%, central obesity was 25% and overweight was 41%. In Hong Kong, the Behavioural Risk Factor Survey conducted by the Government in 2016 found 39% of adults were classified as overweight or obese, of which 21% were obese. The prevalence of central obesity has also risen steadily since 1999 in America. By 2030 is projected to reach 55.6% in men, 80.0% in women, 47.6% among girls and 38.9% among boys in the United States. Overweight, obesity and central obesity are now already pandemic public health issues causing heavy burden on healthcare system. Nowadays, lifestyle modification interventions still remain as the primary strategy to manage obesity and obesity-related complications, among which exercise is low-cost and effective. Substantial evidences have demonstrated effectiveness of HIIT and MICT in reducing body adiposity and improving body Anthropometry. However, studies have also pointed out "lack of time" is one of the major barriers preventing patients from exercise participation. Therefore, studies have put focus on low-frequency or low-volume exercise in improving health to reduce time commitment and increase exercise adherence. Among substantial evidence, our recent study demonstrated once-a-week HIIT is effectively in improving body composition. The effectiveness of low-frequency exercise in reducing visceral fat has also been explored. However, a recent meta-analysis showed low-frequency exercise is not effective in reducing visceral fat. Notably, the authors pointed out most of studies included in the meta-analysis adopted cycling exercise modality and they suggested walking or running exercise which recruits more body muscles may exert better results. In this study, we propose to adopt walking exercise modality to fill the research gap identified by the meta-analysis. Also, no study has compared the effectiveness of low-frequency HIIT and MICT in reducing visceral fat determined by magnetic resonance imaging (MRI) previously. Study aim: to examine the effectiveness of once-a-week high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in reducing visceral fat in adults with central obesity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Obesity
Keywords
Central Obesity, Visceral Fat, HIIT, MICT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded from the group allocation and the participants will be instructed not to reveal his/her intervention assignment.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care control group
Arm Type
Placebo Comparator
Arm Description
Subjects in the usual care control group will receive a health education program to provide the usual care information. This program will include 3-month biweekly sessions (70 minutes each session, total 6 sessions) for obesity-related health briefing, dietary caloric restriction advice, lifestyle counselling/consultation and stretching exercise.
Arm Title
HIIT group
Arm Type
Experimental
Arm Description
A 3-month intervention of HIIT will be given to participants allocated to this group. The once-a-week HIIT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform brisk walking for four 4-min bouts at 85%-95% maximal heart rate (HRmax) with a 3-min active recovery walk at 50%-70% HRmax between each session. There will be a 5-min warm-up and cool-down in each exercise session. The duration of each exercise session will be 35 minutes. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor.
Arm Title
MICT group
Arm Type
Experimental
Arm Description
A 3-month intervention of MICT will be given to participants allocated to this group. The once-a-week MICT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform mild walking exercise for ~47 minutes at an intensity of 65-75% HRmax. This exercise volume matches the HIIT volume. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor.
Intervention Type
Behavioral
Intervention Name(s)
Usual care control group
Intervention Description
Health education
Intervention Type
Behavioral
Intervention Name(s)
HIIT group
Intervention Description
Once-a-week HIIT
Intervention Type
Behavioral
Intervention Name(s)
MICT group
Intervention Description
Once-a-week MICT
Primary Outcome Measure Information:
Title
Visceral fat
Description
The amounts of visceral fat (VAT) at the abdominal region will be assessed by a 1.5-Teala whole-body scanner. A breath-hold localizer scan will be performed prior to the MRI scan. T1-weighted in-phase images will be obtained by fast spoiled gradient-echo sequences during suspended end-expiration. The VAT and between the thoracic diaphragm and the upper broader of the first sacral vertebra will be manually marked on each transverse image to calculate the volume of abdominal VAT.
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Subcutaneous fat
Description
The amounts of subcutaneous fat (SAT) at the abdominal region will be assessed by a 1.5-Teala whole-body scanner. A breath-hold localizer scan will be performed prior to the MRI scan. T1-weighted in-phase images will be obtained by fast spoiled gradient-echo sequences during suspended end-expiration. The SAT between the thoracic diaphragm and the upper broader of the first sacral vertebra will be manually marked on each transverse image to calculate the volume of abdominal SAT.
Time Frame
3-month follow-up
Title
Body fat mass
Description
Total body fat mass will be determined using a full body dual-energy X-ray absorptiometry (DXA) scanner (Explorer S/N 91075, Hologic Inc., Waltham, USA). A trained technician who is blinded to the group allocation will perform the tests and analyze the results.
Time Frame
3-month follow-up
Title
Body fat percentage
Description
Total body fat percentage will be determined using a full body dual-energy X-ray absorptiometry (DXA) scanner (Explorer S/N 91075, Hologic Inc., Waltham, USA). A trained technician who is blinded to the group allocation will perform the tests and analyze the results.
Time Frame
3-month follow-up
Title
Body Mass Index
Description
BMI will be determined by the equation BMI (kg/m2) = bodyweight/height^2. A calibrated electronic balance(UC-321,A&D Weighing, Australia, 150 kg capacity, ± 0.05 kg accuracy) and a stadiometer (Seva 231, Seca, Germany, 205 cm limit, ± 0.05 cm accuracy; ) will be used for the measurements.
Time Frame
3-month follow-up
Title
Waist Circumference 1
Description
Waist circumference will be measured on bare skin midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm following the WHO guideline. Measurement will be performed at the end of normal expiration.
Time Frame
3-month follow-up
Title
Waist Circumference 2
Description
Waist circumference will be measured on bare skin following the National Institutes of Health (NIH) guideline method (the superior border of the iliac crest)using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm. Measurement will be performed at the end of normal expiration.
Time Frame
3-month follow-up
Title
Cardiorespiratory fitness
Description
A maximal exercise test adopting the modified Bruce protocol will be be conducted to determine the maximal oxygen uptake (VO2max) of the subjects. The test will be conducted on a calibrated motor-driven treadmill with continuous metabolic VO2 measurement using a COSMED Quark CPET gas analysis system.
Time Frame
3-month follow-up
Title
Bone Mineral Density
Description
Bone mineral density will be simultaneously determined during the DXA scan for total body fat mass.
Time Frame
3-month follow-up
Title
Lean Mass
Description
Lean mass will be simultaneously determined during the DXA scan for total body fat mass.
Time Frame
3-month follow-up
Title
Health-related Quality of Life
Description
The validated Chinese version 12-item short form survey measures health-related quality of life covering physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning. A higher overall score indicates better quality of life.
Time Frame
3-month follow-up
Title
Adherence
Description
Class attendance will be analysed to indicate adherence to the interventions.
Time Frame
3-month follow-up
Title
Adverse Events
Description
Adverse events will be closely monitored regularly by athletic coaches and research personnel, and by subjects' voluntary reports. Adverse events will be recorded as a secondary outcome.
Time Frame
3-month follow-up
Title
Medication
Description
Detailed information (e.g., drug name, type, dose and daily frequency) on the use of dyslipidemic and hypertensive medications will be recorded at baseline. Subjects altering the dosage of medications after consultation with their physician over the study period will also be recorded as a secondary outcome. The lowest recommended dose (LRD) for 7 days will be used for the analysis.
Time Frame
3-month follow-up
Title
Habitual Physical Activity
Description
Actigraph activity monitor (wGT3X-BT, Actigraph, USA) worn at the wrist region for 24 h over 7 consecutive days will be used to objectively determine habitual daily physical movement/activities.
Time Frame
3-month follow-up
Title
Dietary Intake
Description
Habitual dietary intake will be assessed by 3-day food diary using an electronic scale (KD-400, Tanita, Japan)to determine the daily caloric intake and the relative proportions of macronutrients (carbohydrate, fat, and protein).
Time Frame
3-month follow-up
Title
Blood pressure
Description
Blood pressure will be obtained at the same day with blood collection. Subjects will visit our laboratory in the morning after 10 hours of overnight fasting in order to retrain from consuming caffeine, alcohol, and blood pressure drugs at least 10 hours before the assessment. After 10 minutes of seated rest, blood pressure will be measured on the left arm using a sphygmomanometer. Systolic and diastolic blood pressure and mean arterial pressure will be obtained over the brachial artery region with the arm supported at the heart level using an appropriately sized cuff. Three measurements will be taken with a one-minute interval, and the average value will be recorded for analysis.
Time Frame
3-month follow-up
Title
Hip circumference
Description
Hip circumference will be be taken on bare skin around the widest portion of the buttocks using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm and the tape should be placed parallel to the floor.
Time Frame
3-month follow-up
Title
Self-report habitual physical activity
Description
Self-report habitual physical activity will be measured by International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher level of physical activity.
Time Frame
3-month follow-up
Title
Enjoyment
Description
Enjoyment towards exercise will be quantitatively measured by the Physical Activity Enjoyment Scale. This Chinese scale has an overall score from 18 to 126. While a higher score indicates higher level of enjoyment towards the exercise.
Time Frame
3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 - 60, Central obesity, defined as BMI ≥25 (obesity classification adopted by the Hong Kong Government) with waist circumference of ≥90 cm for men and ≥80 cm for women (abdominal obesity according to the International Diabetes Federation's Chinese ethnic-specific criterion), Males and females will be included to enhance generalizability. Exclusion Criteria: ≥150 minutes moderate-intensity or ≥75 minutes vigorous-intensity exercise weekly, Regular HIIT or MICT (≥1 weekly) in the past 6 months, Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, etc., Somatic conditions that limit exercise participation (e.g., limb loss), Impaired mobility due to chronic diseases (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal and autoimmune diseases), Daily smoking and drinking habit, Surgery, therapy or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, and dietitian-prescribed dietary program).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Fai Parco Siu, PhD
Organizational Affiliation
Li Ka Shing Faculty of Medicine, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Ka Shing Faculty of Medicine, The University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for the data requests, a data-access agreement needs to be signed.
IPD Sharing Time Frame
Beginning 3 months after study publication and ending 3 years.
IPD Sharing Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for the data requests, a data-access agreement needs to be signed.

Learn more about this trial

Effectiveness of High-intensity Interval Training (HIIT) Versus Moderate-intensity Continuous Training (MICT) in Reducing Visceral Fat in Adults With Central Obesity

We'll reach out to this number within 24 hrs