NCT04887454

Brief Summary

The aim of this study is to examine the therapeutic effectiveness of two different exercise frequencies of high-intensity interval training (HIIT; once versus thrice weekly, with matched weekly exercise volume) on improving cardiometabolic risk factors in centrally obese adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

May 10, 2021

Last Update Submit

March 25, 2025

Conditions

Keywords

ObesityCentral ObesityHigh-Intensity Interval TrainingAerobic ExerciseAdultsMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in Body Fat

    Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)

    Baseline and 4 months

Secondary Outcomes (21)

  • Change in Body Fat

    Baseline and 8 months

  • Change in Abdominal Visceral Fat

    Baseline and 4 and 8 months

  • Change in Abdominal Subcutaneous Fat

    Baseline and 4 and 8 months

  • Change in Body Mass Index

    Baseline and 4 and 8 months

  • Change in Waist Circumference

    Baseline and 4 and 8 months

  • +16 more secondary outcomes

Study Arms (3)

Once-Weekly HIIT

EXPERIMENTAL

Once-weekly HIIT for 16 weeks, led by certified athletic coaches

Behavioral: Once-Weekly HIIT

Thrice-Weekly HIIT

EXPERIMENTAL

Thrice-weekly HIIT for 16 weeks, led by certified athletic coaches

Behavioral: Thrice-Weekly HIIT

Usual Care

OTHER

Bi-weekly health education, led by research personnel

Other: Usual Care

Interventions

Participants in this group will receive a 16-week intervention of HIIT once weekly supervised by certified athletic coaches. Participants will perform four 4-minute intervals at 85%-95% peak heart rate with a 3-minute active recovery between each 4-minute interval. Participants will repeat the 25-minute HIIT bout three times with 30-60 minutes break in between each 25-minute HIIT bout. Health information provided to the usual care control group will be made available to the participants in the HIIT groups.

Once-Weekly HIIT

Participants in this group will receive a 16-week intervention of HIIT thrice weekly supervised by certified athletic coaches. Participants will perform four 4-minute intervals at 85%-95% peak heart rate with a 3-minute active recovery between each 4-minute interval. Health information provided to the usual care control group will be made available to the participants in the HIIT groups.

Thrice-Weekly HIIT

Participants in the usual care control 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 obesity including causes, prevalence, epidemiology, associated diseases, healthy diet, caloric restriction advice, physical activity, stress management, adequate sleep, as well as lifestyle counseling/consultation and goal-setting/record-keeping strategies for behavioral changes.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged above 18 years
  • Ethnic Chinese
  • Overweight (BMI ≥23 for Asian)
  • Centrally obese according to IDF and NCEP with Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females)
  • Males and females

You may not qualify if:

  • Medical and somatic conditions that prevent brisk walking
  • Chronic diseases affecting mobility and motor function (e.g., neurological disease, musculoskeletal disorder, spinal cord injury, autoimmune, arthritis, Parkinson's Disease)
  • Chronic diseases affecting cardiorespiratory and metabolic health (e.g., cancers, cardio-/cerebrovascular diseases, heart disease, diabetes mellitus, pneumonia, chronic pulmonary diseases, nephritis, nephrosis)
  • Signs of cardiac arrhythmia indicated by aberrant electrocardiography during incremental VO2max test
  • Regular moderate-to-vigorous intensity exercise (≥150 min weekly) in the past 3 months, as screened by a specially designed questionnaire
  • Daily smoking habit
  • Excess alcohol consumption (daily ≥30g for men, ≥20g for women) in the past six months
  • Claustrophobia
  • Surgery, therapy or medication for obesity or weight loss in the past six months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, and dietitian-prescribed dietary program)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LKS Faculty of Medicine

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Siu PM, Leung CK, Bernal JDK, Yu AP, Recchia F, Tam BT, Fong DYT, Chan DKC, Ngai HH, Lee CH, Yung PSH, Wong SHS, Gibala M. Once and thrice weekly interval training in adults with central obesity: a randomized controlled trial. Nat Commun. 2026 Jan 10. doi: 10.1038/s41467-025-68149-7. Online ahead of print.

  • Leung CK, Bernal JDK, Yu AP, Recchia F, Tam BT, Fong DYT, Chan DKC, Ngai HH, Lee CH, Yung PSH, Wong SHS, Gibala M, Siu PM. Effects of volume-matched once-weekly and thrice-weekly high-intensity interval training (HIIT) on body adiposity in adults with central obesity: Study protocol for a randomized controlled trial. J Exerc Sci Fit. 2024 Oct;22(4):329-340. doi: 10.1016/j.jesf.2024.05.001. Epub 2024 Jun 14.

MeSH Terms

Conditions

ObesityObesity, AbdominalMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Parco M. Siu, PhD

    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

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 14, 2021

Study Start

September 1, 2021

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

The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. 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.

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