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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once-a-week Exercise | Experimental | Once-a-week vigorous-intensity exercise for 4 months. |
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| Thrice-a-week Exercise | Experimental | Thrice-a-week vigorous-intensity exercise for 4 months. |
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| Usual Care Control | Other | Bi-weekly health education for 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Once-a-week Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Fat | Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel. | Baseline and 4 months (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Fat | Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel. | Baseline and 10 months (follow-up) |
| Change in Abdominal Visceral Fat | Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parco M. Siu, PhD | LKS Faculty of Medicine, The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKS Faculty of Medicine | Hong Kong | Hong Kong |
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.
Beginning 3 months and ending 3 years following the publication of the article.
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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| Thrice-a-week Exercise | Behavioral | 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. |
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| Usual Care Control | Other | 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. |
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| 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). | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 4 months (post-intervention), and 10 months (follow-up) |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D050177 | Overweight |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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