Non-Alcoholic Fatty Liver Disease, Obesity
Conditions
Keywords
Non-Alcoholic Fatty Liver Disease, Overweight, Central Obesity, Obesity, Adults, Aerobic Exercise, Exercise Frequency
Brief 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 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).
Interventions
BEHAVIORALOnce-a-week Exercise
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.
BEHAVIORALThrice-a-week Exercise
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.
OTHERUsual Care Control
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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. Cantonese, Mandarin, or English speaking Chinese; 2. Aged 18-69; 3. Male or female; 4. Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23; 5. With NAFLD (defined as \>5% intrahepatic triglycerides assessed by 1H-MRS); 6. Willing to participate in exercise training to improve NAFLD.
Exclusion criteria
1. Regular exercise training (\>3 sessions of \>60 min of moderate-intensity exercise training weekly) in the past 6 months; 2. Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD; 3. Somatic conditions that limit exercise participation (e.g., limb loss); 4. Impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases); 5. Daily smoking habit; 6. Excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year; 7. Consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis; 8. 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); 9. Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Fat | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat | Baseline, 4 months (post-intervention), and 10 months (follow-up) | Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA). |
| Change in Liver Fat | Baseline and 10 months (follow-up) | Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel. |
| Change in Body Mass Index | Baseline, 4 months (post-intervention), and 10 months (follow-up) | Weight and height will be assessed using a calibrated electronic digital weighing scale and a stadiometer, respectively. |
| Change in Waist Circumference | Baseline, 4 months (post-intervention), and 10 months (follow-up) | Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1 cm on bare skin. |
| Change in Abdominal Visceral Fat | Baseline, 4 months (post-intervention), and 10 months (follow-up) | Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI). |
| Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 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. |
| Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 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. |
| Number of Adverse Events | Baseline, 4 months (post-intervention), and 10 months (follow-up) | Adverse events related or unrelated to the intervention will be assessed. |
| Change in Maximal Oxygen Consumption | Baseline, 4 months (post-intervention), and 10 months (follow-up) | Maximal oxygen consumption will be assessed using the modified Bruce protocol. |
Countries
Hong Kong
Contacts
Primary ContactParco M. Siu, PhD
Outcome results
None listed