12-Month Once-a-week HIIT Improves Body Adiposity and Liver Fat

NCT03912272 | Completed DMC

• 1 other identifier: RF-9835-NAFLD-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Liver Fat

  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.

  Change from baseline amount of intrahepatic triglycerides content at 12 months

• Body Adiposity

  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

  Change from baseline amount of body fat mass at 12 months

• Liver Fat

  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.

  Change from baseline amount of intrahepatic triglycerides content at 24 months

• Body Adiposity

  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

  Change from baseline amount of body fat mass at 24 months

Secondary Outcomes (30)

• Visceral Adiposity

  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

• Waist Circumference

  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

Study Arms (2)

Usual Care Control

PLACEBO COMPARATOR

Subjects in the usual care control group will receive a health education program. This program includes 12-month twice-a-month sessions (70 minutes each session) for obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation. The class will be conducted in small group setting (4-8 participants each group). The same health information will be delivered to the subjects in the HIIT group throughout the 12-month intervention period. Subjects will be asked to attend \>70% of the classes.

Behavioral: Usual Care Control

High-intensity Interval Training Group

EXPERIMENTAL

HIIT will be prescribed once weekly under the supervision of certified athletics coaches for 12 months. HIIT training will be performed in a small group setting (4-8 participants each group) in laboratories. In each session, subjects will run for four 4-minute intervals at 85%-95% of the peak heart rate (HRpeak) with a 3-minute active recovery at 50%-70% of the HRpeak between each interval. A 5-minute jog at an intensity of 70% of the HRpeak will be included for warm-up and cool-down before and after, respectively. Subjects will be asked to attend \>70% of the classes.

Behavioral: High-intensity Interval Training

Interventions

High-intensity Interval Training BEHAVIORAL

In the high-intensity interval training group, subjects will receive respective prescribed exercise once a week.

High-intensity Interval Training Group

Usual Care Control BEHAVIORAL

In the usual care control group, obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation will be provided.

Usual Care Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• ≥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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Li Ka Shing Faculty of Medicine, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (11)

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

  PMID: 23303884 BACKGROUND

• Siu PM, Yu AP, Benzie IF, Woo J. Effects of 1-year yoga on cardiovascular risk factors in middle-aged and older adults with metabolic syndrome: a randomized trial. Diabetol Metab Syndr. 2015 Apr 30;7:40. doi: 10.1186/s13098-015-0034-3. eCollection 2015.

  PMID: 26000038 BACKGROUND

• Siu PM. Efficacy of Tai Chi training to alleviate insomnia in older adults. Proceeding of The 6th International Conference on Nutrition and Physical Activity (NAPA 2015), Taipei, Taiwan 2015;p.59

  BACKGROUND

• Siu PM, Yu AP, Yu DS, Hui SS, Woo J. Effectiveness of Tai Chi training to alleviate metabolic syndrome in abdominal obese older adults: A randomized controlled trial.

  BACKGROUND

• Siu PM, Yu AP, Yu DS, Hui SS, Woo J. Effects of Tai Chi Exercise on Cardiometabolic Health and Muscle Content. Proceeding of the 3rd Asian Conference for Frailty and Sarcopenia, Seoul, Korea 2017

  BACKGROUND

• Ramos JS, Dalleck LC, Borrani F, Beetham KS, Mielke GI, Dias KA, Wallen MP, Keating SE, Fassett RG, Coombes JS. High-intensity interval training and cardiac autonomic control in individuals with metabolic syndrome: A randomised trial. Int J Cardiol. 2017 Oct 15;245:245-252. doi: 10.1016/j.ijcard.2017.07.063. Epub 2017 Jul 21.

  PMID: 28747269 BACKGROUND

• Ramos JS, Dalleck LC, Borrani F, Beetham KS, Wallen MP, Mallard AR, Clark B, Gomersall S, Keating SE, Fassett RG, Coombes JS. Low-Volume High-Intensity Interval Training Is Sufficient to Ameliorate the Severity of Metabolic Syndrome. Metab Syndr Relat Disord. 2017 Sep;15(7):319-328. doi: 10.1089/met.2017.0042. Epub 2017 Jun 22.

  PMID: 28846513 BACKGROUND

• Ramos JS, Dalleck LC, Borrani F, Mallard AR, Clark B, Keating SE, Fassett RG, Coombes JS. The effect of different volumes of high-intensity interval training on proinsulin in participants with the metabolic syndrome: a randomised trial. Diabetologia. 2016 Nov;59(11):2308-2320. doi: 10.1007/s00125-016-4064-7. Epub 2016 Aug 1.

  PMID: 27480182 BACKGROUND

• Ramos JS, Dalleck LC, Ramos MV, Borrani F, Roberts L, Gomersall S, Beetham KS, Dias KA, Keating SE, Fassett RG, Sharman JE, Coombes JS. 12 min/week of high-intensity interval training reduces aortic reservoir pressure in individuals with metabolic syndrome: a randomized trial. J Hypertens. 2016 Oct;34(10):1977-87. doi: 10.1097/HJH.0000000000001034.

  PMID: 27467767 BACKGROUND

• Siu PM, Chin EC, Wong SH, Fong DY, Chan DK, Ngai HH, Lee CH, Yung PS. Low-frequency high-intensity interval training (HIIT) improves cardiorespiratory fitness and body composition in overweight adults. Med Sci Sports Exerc 2018:abstract submitted to the 65th American College of Sports Medicine (ACSM) Annual Meeting.

  BACKGROUND

• Chin EC, Leung CK, Yu DJ, Yu AP, Bernal JK, Lai CW, Chan DKC, Ngai HH, Yung PSH, Lee CH, Fong DY, Keating SE, Coombes JS, Siu PM. Effects of one-year once-weekly high-intensity interval training on body adiposity and liver fat in adults with central obesity: Study protocol for a randomized controlled trial. J Exerc Sci Fit. 2022 Apr;20(2):161-171. doi: 10.1016/j.jesf.2022.03.003. Epub 2022 Mar 14.

  PMID: 35401766 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity, Abdominal; Fatty Liver

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ming Fai Parco Siu, PhD

  Li Ka Shing Faculty of Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Division Head, Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: January 1, 2019
• Primary Completion: September 7, 2024
• Study Completion: September 7, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years following the publication of the article
• Access Criteria: 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.

Locations

HK (1)