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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
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.
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.
LKS Faculty of Medicine
Hong Kong, Hong Kong
RECRUITINGChange in Liver Fat
Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel.
Time frame: Baseline and 4 months (post-intervention)
Change in Liver Fat
Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel.
Time frame: Baseline and 10 months (follow-up)
Change in Abdominal Visceral Fat
Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
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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.
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.
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
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.
Time frame: 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.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)