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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Liver Fat
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Exclusion criteria:
- •≥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,
- •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.
排除标准
- 未提供
结局指标
主要结局
Liver Fat
时间窗: 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
时间窗: 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
次要结局
- Fasting glucose(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Medication usage(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Habitual Physical Activity(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Visceral Adiposity(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Bone Mineral Density(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- LDL cholesterol(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Class adherence(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Waist Circumference(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Insulin(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Blood Pressure(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Lean Mass(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Triglycerides(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.)
- Subcutaneous Adiposity(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Body Mass Index(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Hip Circumference(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- VO2max(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- HbA1c(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- HDL cholesterol(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.)
- Dropout rate(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(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Alanine aminotransferase ALT(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Aspartate aminotransferase AST(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Total cholesterol(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(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)(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)(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)(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Sleep Quality(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
- Adverse Events(The adverse events will be recorded during the one-year intervention period)
- Dietary Intake(All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up)
研究者
Parco M. Siu, PhD
Associate Professor and Division Head, Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine
The University of Hong Kong