Clinical trial NCT03912272: 12-Month Once-a-week HIIT Improves Body Adiposity and Liver Fat
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Central Obesity
Keywords: Long-Term Low-Frequency High-Intensity Interval Training
Non-Alcoholic Fatty Liver Disease
Central Obesity
Body Adiposity
Liver Fat
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Cantonese, Mandarin or English speaking,
2. Aged 18-60,
3. 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),
4. Willing to initiate lifestyle modification but not pharmacologic or surgical means for treating obesity.

Exclusion criteria:

1. ≥150 minutes moderate-intensity exercise or ≥75 minutes vigorous exercise weekly,
2. Regular HIIT (≥1 weekly) in the past six months,
3. Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and liver disease except for NAFLD,
4. Somatic conditions that limit exercise participation (e.g., limb loss),
5. Impaired mobility due to chronic diseases (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal and autoimmune diseases),
6. Daily smoking habit,
7. Excess alcohol consumption (daily ≥30 g of alcohol for men and ≥20 g for women) in the past six months
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, and dietitian-prescribed dietary program).
9. 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.

Primary outcomes:
measure: Liver Fat
timeFrame: Change from baseline amount of intrahepatic triglycerides content at 12 months
measure: Body Adiposity
timeFrame: Change from baseline amount of body fat mass at 12 months
measure: Liver Fat
timeFrame: Change from baseline amount of intrahepatic triglycerides content at 24 months
measure: Body Adiposity
timeFrame: Change from baseline amount of body fat mass at 24 months
Secondary outcomes:
measure: Visceral Adiposity
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Subcutaneous Adiposity
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Body Mass Index
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Waist Circumference
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Hip Circumference
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: VO2max
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Blood Pressure
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Lean Mass
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Bone Mineral Density
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Fasting glucose
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Insulin
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: HbA1c
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Alanine aminotransferase ALT
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Aspartate aminotransferase AST
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: LDL cholesterol
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: HDL cholesterol
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
measure: Total cholesterol
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
measure: Triglycerides
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up.
measure: Class adherence
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Dropout rate
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Dose-response relationship between attendance and other outcome variables
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Quality of Life measured by Short Form-12
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Mental Health measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Anxiety level measured by Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Depression level measured by Patient Health Questionnaire-9 (PHQ-9)
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Sleep Quality
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Adverse Events
timeFrame: The adverse events will be recorded during the one-year intervention period
measure: Medication usage
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Habitual Physical Activity
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
measure: Dietary Intake
timeFrame: All assessments will be repeated at 12 months post-intervention and at 24 months at the follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Li Ka Shing Faculty of Medicine, The University of Hong Kong
Study officials:
affiliation: Li Ka Shing Faculty of Medicine, The University of Hong Kong
name: Ming Fai Parco Siu, PhD
role: PRINCIPAL_INVESTIGATOR
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