Non-Alcoholic Fatty Liver DiseaseNCT05741957
Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease
A study testing Once-a-week Exercise and Thrice-a-week Exercise in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- Once-a-week Exercise and Thrice-a-week Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cantonese, Mandarin, or English speaking Chinese;
- Aged 18-69;
- Male or female;
- Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23;
- With NAFLD (defined as >5% intrahepatic triglycerides assessed by 1H-MRS);
- Willing to participate in exercise training to improve NAFLD.
Who cannot join
- Regular exercise training (>3 sessions of >60 min of moderate-intensity exercise training weekly) in the past 6 months;
- Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD;
- Somatic conditions that limit exercise participation (e.g., limb loss);
- Impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases);
- Daily smoking habit;
- Excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year;
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- Consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis;
- 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, or dietitian-prescribed dietary program);
- Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Optimal Exercise Frequency for Alleviating Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease (NAFLD): A Comparative Randomized Controlled Trial
This study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity recommendations.
Read the detailed description
This study is a three-arm randomized controlled trial. Participants will be randomly allocated to the once-a-week exercise group, thrice-a-week exercise group, or usual care control group. The exercise intervention groups will receive once-a-week or thrice-a-week exercise (with matched weekly exercise volumes). The usual care control group will receive general health education. All interventions will last for 4 months. Outcome measures will be examined at baseline, 4 months (post-intervention), and 10 months (6-month follow-up).
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Being tested
- Once-a-week Exercise, Thrice-a-week Exercise, Usual Care Control
- Keywords
- Non-Alcoholic Fatty Liver Disease, Overweight, Central Obesity, Obesity, Adults, Aerobic Exercise, Exercise Frequency
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Overweight, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once-a-week ExerciseBehavioural
Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve one session weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 75 min. Participants will exercise with an exercising heart rate at 6-7 metabolic equivalents (METs). Health information provided to the usual care control group will be made available to the participants in this group.
Thrice-a-week ExerciseBehavioural
Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve three sessions weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 25 min. Participants will exercise with an exercising heart rate at 6-7 METs. Health information provided to the usual care control group will be made available to the participants in this group.
Usual Care ControlOther
Participants in this group will receive health education delivered by research personnel. This program will consist of eight two-hour bi-weekly sessions covering major health issues relating to general health and NAFLD, such as non-communicable diseases, infectious diseases, and a healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Once-a-week Exercise | Experimental | Once-a-week vigorous-intensity exercise for 4 months. Receives: Behavioral: Once-a-week Exercise |
| Thrice-a-week Exercise | Experimental | Thrice-a-week vigorous-intensity exercise for 4 months. Receives: Behavioral: Thrice-a-week Exercise |
| Usual Care Control | Other | Bi-weekly health education for 4 months. Receives: Other: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Fat
Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel.
Measured: Baseline and 4 months (post-intervention)
Secondary outcomes (9)
Change in Liver Fat
Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel.
Measured: Baseline and 10 months (follow-up)
Change in Abdominal Visceral Fat
Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI).
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Body Fat
Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA).
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Body Mass Index
Weight and height will be assessed using a calibrated electronic digital weighing scale and a stadiometer, respectively.
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Waist Circumference
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1 cm on bare skin.
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Maximal Oxygen Consumption
Maximal oxygen consumption will be assessed using the modified Bruce protocol.
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey
Physical health-related quality of life will be assessed using the Physical Component Summary scale of the 12-Item Short-Form Health Survey (SF-12). Scores on the scale range from 0 to 100, with higher scores indicating better physical health-related quality of life.
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey
Mental health-related quality of life will be assessed using the Mental Component Summary scale of the 12-Item Short-Form Health Survey (SF-12). Scores on the scale range from 0 to 100, with higher scores indicating better mental health-related quality of life.
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Number of Adverse Events
Adverse events related or unrelated to the intervention will be assessed.
Measured: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start2 Mar 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parco M. Siu, PhD, The University of Hong Kong
- Investigators
- Parco M. Siu, PhD, Principal investigator, LKS Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741957
- Sponsor's protocol ID
- HKU-NFF
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Optimal Exercise Frequency for Alleviating Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease (NAFLD): A Comparative Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05741957
- Acronym / sponsor ID
- HKU-NFF
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Keywords
- Non-Alcoholic Fatty Liver Disease, Overweight, Central Obesity, Obesity, Adults, Aerobic Exercise, Exercise Frequency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Feb 2023 (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.
This study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity recommendations.
Detailed description
This study is a three-arm randomized controlled trial. Participants will be randomly allocated to the once-a-week exercise group, thrice-a-week exercise group, or usual care control group. The exercise intervention groups will receive once-a-week or thrice-a-week exercise (with matched weekly exercise volumes). The usual care control group will receive general health education. All interventions will last for 4 months. Outcome measures will be examined at baseline, 4 months (post-intervention), and 10 months (6-month follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Once-a-week Exercise | Experimental | Behavioral: Once-a-week ExerciseOnce-a-week vigorous-intensity exercise for 4 months. |
| Thrice-a-week Exercise | Experimental | Behavioral: Thrice-a-week ExerciseThrice-a-week vigorous-intensity exercise for 4 months. |
| Usual Care Control | Other | Other: Usual Care ControlBi-weekly health education for 4 months. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cantonese, Mandarin, or English speaking Chinese;
- Aged 18-69;
- Male or female;
- Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23;
- With NAFLD (defined as >5% intrahepatic triglycerides assessed by 1H-MRS);
Key exclusion criteria (9 listed)
- Regular exercise training (>3 sessions of >60 min of moderate-intensity exercise training weekly) in the past 6 months;
- Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD;
- Somatic conditions that limit exercise participation (e.g., limb loss);
- Impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases);
- Daily smoking habit;
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 |
|---|---|---|
| Once-a-week ExerciseParticipants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve one session weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 75 min. Participants will exercise with an exercising heart rate at 6-7 metabolic equivalents (METs). Health information provided to the usual care control group will be made available to the participants in this group. | Behavioural | Once-a-week Exercise |
| Thrice-a-week ExerciseParticipants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve three sessions weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 25 min. Participants will exercise with an exercising heart rate at 6-7 METs. Health information provided to the usual care control group will be made available to the participants in this group. | Behavioural | Thrice-a-week Exercise |
| Usual Care ControlParticipants in this group will receive health education delivered by research personnel. This program will consist of eight two-hour bi-weekly sessions covering major health issues relating to general health and NAFLD, such as non-communicable diseases, infectious diseases, and a healthy lifestyle. | Other | Usual Care Control |
Primary outcome
Change in Liver Fat
Time frame: Baseline and 4 months (post-intervention)
Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel.
9 secondary outcomes
Change in Liver Fat
Time frame: Baseline and 10 months (follow-up)
Change in Abdominal Visceral Fat
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Body Fat
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Body Mass Index
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Waist Circumference
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Maximal Oxygen Consumption
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Number of Adverse Events
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- 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.
Parco M. Siu, PhD principal investigator
LKS 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 Once-a-week Exercise and Thrice-a-week Exercise in people with Non-Alcoholic Fatty Liver Disease and 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 6 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: under way, not looking for participants, as of the sponsor's last update on 1 May 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Liver Fat (time frame: Baseline and 4 months (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.