Non-Alcoholic Fatty Liver DiseaseNCT03912272

12-Month Once-a-week HIIT Improves Body Adiposity and Liver Fat

A study testing High-intensity Interval Training in people with Non-Alcoholic Fatty Liver Disease and Central Obesity, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Non-Alcoholic Fatty Liver Disease, Central Obesity
What is being tested?: High-intensity Interval Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteHong Kong
Study dates: 16 Jul 2019to 7 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Cantonese, Mandarin or English speaking,
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),
Willing to initiate lifestyle modification but not pharmacologic or surgical means for treating obesity.

Who cannot join

≥150 minutes moderate-intensity exercise or ≥75 minutes vigorous exercise weekly,
Regular HIIT (≥1 weekly) in the past six months,
Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and liver disease except for NAFLD,
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 habit,

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Excess alcohol consumption (daily ≥30 g of alcohol for men and ≥20 g for women) in the past six months
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).
During the study period, subjects identified with major physical changes that would considerably affect their body composition and weight (e.g., anorexia nervosa, bulimia nervosa, and prolonged gastrointestinal and digestive disorders) will be excluded.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

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

Other trials in Hong Kong

About this study

Official title: Effectiveness of Long-term Low-frequency High-Intensity Interval Training (HIIT) to Improve Body Adiposity and Liver Fat in Adults With Central Obesity: A Randomized Controlled Trial

Obesity and non-alcoholic fatty liver disease (NAFLD) are two related growing epidemics that are becoming pressing public health concerns. High-intensity interval training (HIIT) is a promising cost-effective and time-efficient exercise modality for managing obesity and NAFLD. However, patients with obesity and NAFLD are generally inactive and unfit, and might feel intimidated by the frequency of the prescribed HIIT (conventionally three times weekly). Previous HIIT studies, mostly over 2-4 month periods, showed that the participants could accomplish this exercise frequency under a controlled laboratory environment, but the long-term adherence and sustainability, especially in a field setting, remains uncertain. The situation is more unclear if we also consider those individuals who refused to participate possibly because of their overwhelming perceptions or low self-efficacy toward HIIT. Thus, logically, HIIT at a lower frequency would be practical and more suitable for patients with obesity and NAFLD, but the minimum exercise frequency required to improve health, especially in the long-term, is unknown. This proposed study aims to examine the effectiveness of long-term low-frequency HIIT for improving body adiposity and liver fat in centrally obese adults. The premise of this proposal is supported by recent findings that HIIT performed once a week could improve cardiorespiratory fitness, blood pressure, cardiac morphology, metabolic capacity, muscle power, and lean mass. This study will provide evidence for the benefits of long-term low-frequency HIIT with a follow-up period to assess its effectiveness, safety, adherence, and sustainability. We expect this intervention will enhance the practical suitability of HIIT in inactive obese adults and will provide evidence for low-frequency HIIT as a new exercise option in the management of obesity and NAFLD.

Conditions: Non-Alcoholic Fatty Liver Disease, Central Obesity
Being tested: High-intensity Interval Training, Usual Care Control
Keywords: Long-Term Low-Frequency High-Intensity Interval Training, Non-Alcoholic Fatty Liver Disease, Central Obesity, Body Adiposity, Liver Fat
Medical subject headings: Non-alcoholic Fatty Liver Disease, Obesity, Abdominal, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High-intensity Interval TrainingBehavioural
In the high-intensity interval training group, subjects will receive respective prescribed exercise once a week.
Usual Care ControlBehavioural
In the usual care control group, obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation will be provided.

Study groups in NCT03912272
Study group	Role	What they receive
Usual Care Control	Placebo comparator	Subjects in the usual care control group will receive a health education program. This program includes 12-month twice-a-month sessions (70 minutes each session) for obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation. The class will be conducted in small group setting (4-8 participants each group). The same health information will be delivered to the subjects in the HIIT group throughout the 12-month intervention period. Subjects will be asked to attend >70% of the classes. Receives: Behavioral: Usual Care Control
High-intensity Interval Training Group	Experimental	HIIT will be prescribed once weekly under the supervision of certified athletics coaches for 12 months. HIIT training will be performed in a small group setting (4-8 participants each group) in laboratories. In each session, subjects will run for four 4-minute intervals at 85%-95% of the peak heart rate (HRpeak) with a 3-minute active recovery at 50%-70% of the HRpeak between each interval. A 5-minute jog at an intensity of 70% of the HRpeak will be included for warm-up and cool-down before and after, respectively. Subjects will be asked to attend >70% of the classes. Receives: Behavioral: High-intensity Interval Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Liver Fat
Intrahepatic triglycerides will be examined by 1H-MR spectroscopy in a 3×3×3 cm voxel using a 1.5-Tesla scanner (SIGNA™ Explorer - 60cm, General Electric Healthcare) housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results. NAFLD will be defined as >5% intrahepatic triglycerides assessed by 1H-MR spectroscopy.
Measured: Change from baseline amount of intrahepatic triglycerides content at 12 months
Body Adiposity
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 will operate the DXA machine, position the subjects and analyze the results. The typical coefficients of variation of the DXA scanner for each body compartment from duplicate analyses are 0.4% for lean mass, 1.4% for fat mass and 1.0% for bone mass
Measured: Change from baseline amount of body fat mass at 12 months
Liver Fat
Intrahepatic triglycerides will be examined by 1H-MR spectroscopy in a 3×3×3 cm voxel using a 1.5-Tesla scanner (SIGNA™ Explorer - 60cm, General Electric Healthcare) housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results. NAFLD will be defined as >5% intrahepatic triglycerides assessed by 1H-MR spectroscopy.
Measured: Change from baseline amount of intrahepatic triglycerides content at 24 months
Body Adiposity
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 will operate the DXA machine, position the subjects and analyze the results. The typical coefficients of variation of the DXA scanner for each body compartment from duplicate analyses are 0.4% for lean mass, 1.4% for fat mass and 1.0% for bone mass
Measured: Change from baseline amount of body fat mass at 24 months

Secondary outcomes (30)

Visceral Adiposity
Abdominal visceral fat will be measured using a three-point Dixon sequence using a 1.5-Tesla scanner (SIGNA™ Explorer - 60cm, General Electric Healthcare) housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results. The abdominal visceral fat between the thoracic diaphragm and the upper bORDER of the first sacral vertebra will be manually marked on each MRI transverse image to calculate the volume of abdominal visceral fat.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Subcutaneous Adiposity
Subcutaneous fat will be measured using a three-point Dixon sequence using 1.5-Tesla scanner (SIGNA™ Explorer - 60cm, General Electric Healthcare) housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results. The abdominal subcutaneous fat between the thoracic diaphragm and the upper border of the first sacral vertebra will be manually marked on each MRI transverse
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Body Mass Index
A calibrated electronic digital weighing scale (UC321, A\&D Medical) with a capacity from 0.05kg to 150kg (± 0.05kg accuracy) will be used to weigh the subjects. A stadiometer (Holtain Ltd., UK) with 200 cm limit and ± 0.01 cm accuracy will be used to measure body height. The BMI will be calculated from the body weight and height.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Waist Circumference
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 to the nearest 0.1 cm. Measurement will be performed at the end of normal expiration.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Hip Circumference
Hip circumference will be be taken on bare skin around the widest portion of the buttocks using an inelastic measuring tape to the nearest 0.1 cm and the tape should be placed parallel to the floor.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
VO2max
VO2max test will be conducted using a calibrated motor-driven treadmill (LE500C, Jaeger, Germany) by continuous metabolic VO2 measurement using a Cosmed K5 portable telemetric gas analysis system. The test will be performed using a ramp protocol where the speed will be constant and the incline will be increased by 2% every second minute until VO2max is reached. Capillary blood will be obtained before and immediately after the test for the blood lactate analysis. The highest value of VO2 which meets one of the following criteria will be considered as the VO2max: 1) plateau of VO2 with increasing intensity, 2) respiratory exchange ratio (RER) ≥1.05, and 3) post-exercise blood lactate exceeding 8 mmol/L.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Blood Pressure
Subjects will abstain from consuming caffeine and alcohol at least 10 hours prior to the assessment. After 10 minutes rest in the seated position, blood pressure will be measured on the right arm using a blood pressure monitor (M3 Vital Signs Monitor, EDAN). 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. Measurements will be repeated after 10 minutes and the average of two separate measurements will be recorded for the analysis.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Lean Mass
Total body lean mass will be determined by using DXA scan.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Bone Mineral Density
Bone mineral density will be determined by using DXA scan.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Fasting glucose
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of fasting glucose.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Insulin
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of insulin.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
HbA1c
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of HbA1c.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Alanine aminotransferase ALT
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of ALT.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Aspartate aminotransferase AST
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of AST.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
LDL cholesterol
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of LDL cholesterol.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
HDL cholesterol
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of HDL cholesterol.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
Total cholesterol
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of total cholesterol.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
Triglycerides
Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of triglycerides.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
Class adherence
Class attendance will be recorded to indicate adherence to HIIT intervention. Subjects will be encouraged to achieve >70% class attendance over the year.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Dropout rate
The reasons for dropout will be ascertained and reported.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Dose-response relationship between attendance and other outcome variables
Secondary analysis will be performed based on the attendance rate to examine the dose-response relationship between HIIT and the other outcome variables.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Quality of Life measured by Short Form-12
The validated Chinese version Standard SF-12 Health Survey will be used to measure health-related quality of life. This 12-item questionnaire assesses physical functioning, emotional and mental health, bodily pain, general health, vitality and social functioning. A higher overall score indicates better quality of life.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Mental Health measured by the Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) will also be used to evaluate the severity of depression and anxiety. This 7-item questionnaire has an overall score ranging from 0 to 21 (with subscales for both anxiety and depression). A higher score indicates more severe symptoms.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Anxiety level measured by Generalized Anxiety Disorder-7 (GAD-7)
Generalized Anxiety Disorder-7 (GAD-7) will also be used to measure the anxiety level of the subjects. This 7-item questionnaire has an overall score ranging from 0 to 21. A higher score indicates more severe symptoms.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Depression level measured by Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9) will also be used to measure the depression level of the subjects. This 10-item questionnaire has an overall score ranging from 0 to 30. A higher score indicates more severe symptoms.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) will be used to measure the subjective sleep quality of the subjects. The score of this scale ranges from 0 to 21. Higher score indicates worse subjective sleep quality.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Adverse Events
Adverse events will be closely monitored through regular surveys by the athletics coaches and research personnel, and by voluntary reports from the subjects. The incidence rate in both usual care control group and HIIT group will be calculated as incidence rate = number of adverse events in each group / number of participants in each group.
Measured: The adverse events will be recorded during the one-year intervention period
Medication usage
The number of participants in each group using dyslipidemic and hypertensive medications will be recorded, including e.g., drug name, type, dose and weekly frequency).
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Habitual Physical Activity
Habitual physical activity will be measured by International Physical Activity Questionnaire (IPAQ) and 7-day actigraph. Subjects will wear the actigraph at the hip region for 24 hours over 8 consecutive days. The first day will be a trial and not be included into the analysis.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Dietary Intake
The dietary intake will be measured by 3-day weighed food record and analyzed by Food Processor, ESHA. A food ingestion report will be generated by the software, including total calories intake, proportion of major macro nutrients.
Measured: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 20197 Sep 2024

First posted11 Apr 2019
Study start16 Jul 2019
Primary completion7 Sep 2024
Study completion7 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03912272
Sponsor's protocol ID: RF-9835-NAFLD-001
Status last verified: Sep 2026
First submitted: 9 Apr 2019
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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 data request, a data-access agreement needs to be signed.

Publications

Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884
Siu PM, Yu AP, Benzie IF, Woo J. Effects of 1-year yoga on cardiovascular risk factors in middle-aged and older adults with metabolic syndrome: a randomized trial. Diabetol Metab Syndr. 2015 Apr 30;7:40. doi: 10.1186/s13098-015-0034-3. eCollection 2015.
PubMed 26000038
Siu PM. Efficacy of Tai Chi training to alleviate insomnia in older adults. Proceeding of The 6th International Conference on Nutrition and Physical Activity (NAPA 2015), Taipei, Taiwan 2015;p.59
Siu PM, Yu AP, Yu DS, Hui SS, Woo J. Effectiveness of Tai Chi training to alleviate metabolic syndrome in abdominal obese older adults: A randomized controlled trial.
Siu PM, Yu AP, Yu DS, Hui SS, Woo J. Effects of Tai Chi Exercise on Cardiometabolic Health and Muscle Content. Proceeding of the 3rd Asian Conference for Frailty and Sarcopenia, Seoul, Korea 2017
Ramos JS, Dalleck LC, Borrani F, Beetham KS, Mielke GI, Dias KA, Wallen MP, Keating SE, Fassett RG, Coombes JS. High-intensity interval training and cardiac autonomic control in individuals with metabolic syndrome: A randomised trial. Int J Cardiol. 2017 Oct 15;245:245-252. doi: 10.1016/j.ijcard.2017.07.063. Epub 2017 Jul 21.
PubMed 28747269
Ramos JS, Dalleck LC, Borrani F, Beetham KS, Wallen MP, Mallard AR, Clark B, Gomersall S, Keating SE, Fassett RG, Coombes JS. Low-Volume High-Intensity Interval Training Is Sufficient to Ameliorate the Severity of Metabolic Syndrome. Metab Syndr Relat Disord. 2017 Sep;15(7):319-328. doi: 10.1089/met.2017.0042. Epub 2017 Jun 22.
PubMed 28846513
Ramos JS, Dalleck LC, Borrani F, Mallard AR, Clark B, Keating SE, Fassett RG, Coombes JS. The effect of different volumes of high-intensity interval training on proinsulin in participants with the metabolic syndrome: a randomised trial. Diabetologia. 2016 Nov;59(11):2308-2320. doi: 10.1007/s00125-016-4064-7. Epub 2016 Aug 1.
PubMed 27480182
Ramos JS, Dalleck LC, Ramos MV, Borrani F, Roberts L, Gomersall S, Beetham KS, Dias KA, Keating SE, Fassett RG, Sharman JE, Coombes JS. 12 min/week of high-intensity interval training reduces aortic reservoir pressure in individuals with metabolic syndrome: a randomized trial. J Hypertens. 2016 Oct;34(10):1977-87. doi: 10.1097/HJH.0000000000001034.
PubMed 27467767
Siu PM, Chin EC, Wong SH, Fong DY, Chan DK, Ngai HH, Lee CH, Yung PS. Low-frequency high-intensity interval training (HIIT) improves cardiorespiratory fitness and body composition in overweight adults. Med Sci Sports Exerc 2018:abstract submitted to the 65th American College of Sports Medicine (ACSM) Annual Meeting.
Chin EC, Leung CK, Yu DJ, Yu AP, Bernal JK, Lai CW, Chan DKC, Ngai HH, Yung PSH, Lee CH, Fong DY, Keating SE, Coombes JS, Siu PM. Effects of one-year once-weekly high-intensity interval training on body adiposity and liver fat in adults with central obesity: Study protocol for a randomized controlled trial. J Exerc Sci Fit. 2022 Apr;20(2):161-171. doi: 10.1016/j.jesf.2022.03.003. Epub 2022 Mar 14.
PubMed 35401766

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Long-term Low-frequency High-Intensity Interval Training (HIIT) to Improve Body Adiposity and Liver Fat in Adults With Central Obesity: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03912272
Acronym / sponsor ID: RF-9835-NAFLD-001
Conditions: Non-Alcoholic Fatty Liver Disease, Central Obesity
Keywords: Long-Term Low-Frequency High-Intensity Interval Training, Non-Alcoholic Fatty Liver Disease, Central Obesity, Body Adiposity, Liver Fat
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: 16 Jul 2019 (actual)
Primary completion: 7 Sep 2024 (actual)
Study completion: 7 Sep 2024 (actual)
First posted: 11 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Usual Care Control	Placebo comparator	Behavioral: Usual Care ControlSubjects in the usual care control group will receive a health education program. This program includes 12-month twice-a-month sessions (70 minutes each session) for obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation. The class will be conducted in small group setting (4-8 participants each group). The same health information will be delivered to the subjects in the HIIT group throughout the 12-month intervention period. Subjects will be asked to attend >70% of the classes.
High-intensity Interval Training Group	Experimental	Behavioral: High-intensity Interval TrainingHIIT will be prescribed once weekly under the supervision of certified athletics coaches for 12 months. HIIT training will be performed in a small group setting (4-8 participants each group) in laboratories. In each session, subjects will run for four 4-minute intervals at 85%-95% of the peak heart rate (HRpeak) with a 3-minute active recovery at 50%-70% of the HRpeak between each interval. A 5-minute jog at an intensity of 70% of the HRpeak will be included for warm-up and cool-down before and after, respectively. Subjects will be asked to attend >70% of the classes.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Cantonese, Mandarin or English speaking,
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),
Willing to initiate lifestyle modification but not pharmacologic or surgical means for treating obesity.

Key exclusion criteria (9 listed)

≥150 minutes moderate-intensity exercise or ≥75 minutes vigorous exercise weekly,
Regular HIIT (≥1 weekly) in the past six months,
Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and liver disease except for NAFLD,
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),

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High-intensity Interval TrainingIn the high-intensity interval training group, subjects will receive respective prescribed exercise once a week.	Behavioural	High-intensity Interval Training Group
Usual Care ControlIn the usual care control group, obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation will be provided.	Behavioural	Usual Care Control

Primary outcome

Liver Fat
Time frame: Change from baseline amount of intrahepatic triglycerides content at 12 months
Intrahepatic triglycerides will be examined by 1H-MR spectroscopy in a 3×3×3 cm voxel using a 1.5-Tesla scanner (SIGNA™ Explorer - 60cm, General Electric Healthcare) housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results. NAFLD will be defined as >5% intrahepatic triglycerides assessed by 1H-MR spectroscopy.
Body Adiposity
Time frame: Change from baseline amount of body fat mass at 12 months
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 will operate the DXA machine, position the subjects and analyze the results. The typical coefficients of variation of the DXA scanner for each body compartment from duplicate analyses are 0.4% for lean mass, 1.4% for fat mass and 1.0% for bone mass
Liver Fat
Time frame: Change from baseline amount of intrahepatic triglycerides content at 24 months
Intrahepatic triglycerides will be examined by 1H-MR spectroscopy in a 3×3×3 cm voxel using a 1.5-Tesla scanner (SIGNA™ Explorer - 60cm, General Electric Healthcare) housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results. NAFLD will be defined as >5% intrahepatic triglycerides assessed by 1H-MR spectroscopy.
Body Adiposity
Time frame: Change from baseline amount of body fat mass at 24 months
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 will operate the DXA machine, position the subjects and analyze the results. The typical coefficients of variation of the DXA scanner for each body compartment from duplicate analyses are 0.4% for lean mass, 1.4% for fat mass and 1.0% for bone mass

30 secondary outcomes

Visceral Adiposity
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Subcutaneous Adiposity
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Body Mass Index
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Waist Circumference
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Hip Circumference
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
VO2max
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Blood Pressure
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Lean Mass
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Bone Mineral Density
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Fasting glucose
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Insulin
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
HbA1c
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Alanine aminotransferase ALT
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Aspartate aminotransferase AST
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
LDL cholesterol
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
HDL cholesterol
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
Total cholesterol
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
Triglycerides
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
Class adherence
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Dropout rate
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Dose-response relationship between attendance and other outcome variables
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Quality of Life measured by Short Form-12
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Mental Health measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Anxiety level measured by Generalized Anxiety Disorder-7 (GAD-7)
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Depression level measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Sleep Quality
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Adverse Events
Time frame: The adverse events will be recorded during the one-year intervention period
Medication usage
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Habitual Physical Activity
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Dietary Intake
Time frame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
Background: PubMed 26000038Siu PM, Yu AP, Benzie IF, Woo J. Effects of 1-year yoga on cardiovascular risk factors in middle-aged and older adults with metabolic syndrome: a randomized trial. Diabetol Metab Syndr. 2015 Apr 30;7:40. doi: 10.1186/s13098-015-0034-3. eCollection 2015.
BackgroundSiu PM. Efficacy of Tai Chi training to alleviate insomnia in older adults. Proceeding of The 6th International Conference on Nutrition and Physical Activity (NAPA 2015), Taipei, Taiwan 2015;p.59
BackgroundSiu PM, Yu AP, Yu DS, Hui SS, Woo J. Effectiveness of Tai Chi training to alleviate metabolic syndrome in abdominal obese older adults: A randomized controlled trial.
BackgroundSiu PM, Yu AP, Yu DS, Hui SS, Woo J. Effects of Tai Chi Exercise on Cardiometabolic Health and Muscle Content. Proceeding of the 3rd Asian Conference for Frailty and Sarcopenia, Seoul, Korea 2017
Background: PubMed 28747269Ramos JS, Dalleck LC, Borrani F, Beetham KS, Mielke GI, Dias KA, Wallen MP, Keating SE, Fassett RG, Coombes JS. High-intensity interval training and cardiac autonomic control in individuals with metabolic syndrome: A randomised trial. Int J Cardiol. 2017 Oct 15;245:245-252. doi: 10.1016/j.ijcard.2017.07.063. Epub 2017 Jul 21.
Background: PubMed 28846513Ramos JS, Dalleck LC, Borrani F, Beetham KS, Wallen MP, Mallard AR, Clark B, Gomersall S, Keating SE, Fassett RG, Coombes JS. Low-Volume High-Intensity Interval Training Is Sufficient to Ameliorate the Severity of Metabolic Syndrome. Metab Syndr Relat Disord. 2017 Sep;15(7):319-328. doi: 10.1089/met.2017.0042. Epub 2017 Jun 22.
Background: PubMed 27480182Ramos JS, Dalleck LC, Borrani F, Mallard AR, Clark B, Keating SE, Fassett RG, Coombes JS. The effect of different volumes of high-intensity interval training on proinsulin in participants with the metabolic syndrome: a randomised trial. Diabetologia. 2016 Nov;59(11):2308-2320. doi: 10.1007/s00125-016-4064-7. Epub 2016 Aug 1.
Background: PubMed 27467767Ramos JS, Dalleck LC, Ramos MV, Borrani F, Roberts L, Gomersall S, Beetham KS, Dias KA, Keating SE, Fassett RG, Sharman JE, Coombes JS. 12 min/week of high-intensity interval training reduces aortic reservoir pressure in individuals with metabolic syndrome: a randomized trial. J Hypertens. 2016 Oct;34(10):1977-87. doi: 10.1097/HJH.0000000000001034.
BackgroundSiu PM, Chin EC, Wong SH, Fong DY, Chan DK, Ngai HH, Lee CH, Yung PS. Low-frequency high-intensity interval training (HIIT) improves cardiorespiratory fitness and body composition in overweight adults. Med Sci Sports Exerc 2018:abstract submitted to the 65th American College of Sports Medicine (ACSM) Annual Meeting.
Derived from this study: PubMed 35401766Chin EC, Leung CK, Yu DJ, Yu AP, Bernal JK, Lai CW, Chan DKC, Ngai HH, Yung PSH, Lee CH, Fong DY, Keating SE, Coombes JS, Siu PM. Effects of one-year once-weekly high-intensity interval training on body adiposity and liver fat in adults with central obesity: Study protocol for a randomized controlled trial. J Exerc Sci Fit. 2022 Apr;20(2):161-171. doi: 10.1016/j.jesf.2022.03.003. Epub 2022 Mar 14.
Individual participant dataSharing planned: Yes. 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 data request, a data-access agreement needs to be signed.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ming Fai Parco Siu, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity Interval Training in people with Non-Alcoholic Fatty Liver Disease and Central Obesity, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver Fat (time frame: Change from baseline amount of intrahepatic triglycerides content at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912272, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.