search
Back to results

Optimal Frequency of High-Intensity Interval Training for Centrally Obese Adults

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Once-Weekly HIIT
Thrice-Weekly HIIT
Usual Care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Central Obesity, High-Intensity Interval Training, Aerobic Exercise, Adults, Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • LKS Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Once-Weekly HIIT

Thrice-Weekly HIIT

Usual Care

Arm Description

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

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

Bi-weekly health education, led by research personnel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Body Fat
Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)
Change in Abdominal Visceral Fat
Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI)
Change in Abdominal Subcutaneous Fat
Abdominal subcutaneous fat will be assessed using magnetic resonance imaging (MRI)
Change in Body Mass Index
Weight and height will be assessed using a calibrated electronic digital weighing scale and stadiometer respectively
Change in Waist Circumference
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1cm on bare skin
Change in Systolic Blood Pressure
Resting systolic blood pressure will be assessed
Change in Diastolic Blood Pressure
Resting diastolic blood pressure will be assessed
Change in Fasting Glucose
Fasting glucose will be analyzed from venous blood by an accredited medical laboratory
Change in Fasting Triglycerides
Fasting triglycerides will be analyzed from venous blood by an accredited medical laboratory
Change in Fasting Low Density Lipoprotein Cholesterol (LDL-C)
Fasting LDL-C will be analyzed from venous blood by an accredited medical laboratory
Change in Fasting High Density Lipoprotein Cholesterol (HDL-C)
Fasting HDL-C will be analyzed from venous blood by an accredited medical laboratory
Change in Fasting Total Cholesterol
Fasting total cholesterol will be analyzed from venous blood by an accredited medical laboratory
Change in Proportion of Metabolic Syndrome Diagnosis
Metabolic syndrome diagnosis will be evaluated with waist circumference, triglycerides, HDL-C, blood pressure, and fasting glucose
Number of Adverse Events
Adverse events related or unrelated to training will be assessed
Change in Organ Fat
Organ fat will be assessed using magnetic resonance imaging (MRI)
Change in SF-12 Physical Component Summary Score
Physical health-related quality of life will be assessed using the Physical Component Summary Score of the 12-Item Short-Form Health Survey (SF-12)
Change in SF-12 Mental Component Summary Score
Mental health-related quality of life will be assessed using the Mental Component Summary Score of the 12-Item Short-Form Health Survey (SF-12)
Change in HADS-D Score
HADS-D score will be assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Change in PHQ-9 Score
PHQ-9 score will be assessed using the Patient Health Questionnaire-9 (PHQ-9)
Change in HADS-A Score
HADS-A score will be assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Change in GAD-7 Score
GAD-7 score will be assessed using the General Anxiety Disorder-7 (GAD-7) Questionnaire

Full Information

First Posted
May 10, 2021
Last Updated
August 25, 2022
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04887454
Brief Title
Optimal Frequency of High-Intensity Interval Training for Centrally Obese Adults
Official Title
Optimal Frequency of High-Intensity Interval Training for Centrally Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
HIIT is an emerging, popular, promising, cost-effective, and time-efficient exercise modality for managing obesity. Although lower-frequency HIIT is favorable for intervention adherence, the optimal exercise frequency of HIIT for alleviating obesity is unknown. This study is a three-arm randomized controlled trial. Centrally obese adults will be randomly allocated to three groups: the usual care control, once and thrice-weekly HIIT groups. Led by research personnel, the usual care group will receive obesity-related health education. Led by athletic coaches, the HIIT intervention groups will receive 16 weeks of once or thrice weekly HIIT (with matched weekly exercise volume). Outcome measures of this study will be examined at baseline, 4 months (post-intervention), and 8 months (follow-up), by assessors blinded to group allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Central Obesity, High-Intensity Interval Training, Aerobic Exercise, Adults, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Once-Weekly HIIT
Arm Type
Experimental
Arm Description
Once-weekly HIIT for 16 weeks, led by certified athletic coaches
Arm Title
Thrice-Weekly HIIT
Arm Type
Experimental
Arm Description
Thrice-weekly HIIT for 16 weeks, led by certified athletic coaches
Arm Title
Usual Care
Arm Type
Other
Arm Description
Bi-weekly health education, led by research personnel
Intervention Type
Behavioral
Intervention Name(s)
Once-Weekly HIIT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Thrice-Weekly HIIT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Fat
Description
Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Change in Body Fat
Description
Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline and 8 months
Title
Change in Abdominal Visceral Fat
Description
Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI)
Time Frame
Baseline and 4 and 8 months
Title
Change in Abdominal Subcutaneous Fat
Description
Abdominal subcutaneous fat will be assessed using magnetic resonance imaging (MRI)
Time Frame
Baseline and 4 and 8 months
Title
Change in Body Mass Index
Description
Weight and height will be assessed using a calibrated electronic digital weighing scale and stadiometer respectively
Time Frame
Baseline and 4 and 8 months
Title
Change in Waist Circumference
Description
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1cm on bare skin
Time Frame
Baseline and 4 and 8 months
Title
Change in Systolic Blood Pressure
Description
Resting systolic blood pressure will be assessed
Time Frame
Baseline and 4 and 8 months
Title
Change in Diastolic Blood Pressure
Description
Resting diastolic blood pressure will be assessed
Time Frame
Baseline and 4 and 8 months
Title
Change in Fasting Glucose
Description
Fasting glucose will be analyzed from venous blood by an accredited medical laboratory
Time Frame
Baseline and 4 and 8 months
Title
Change in Fasting Triglycerides
Description
Fasting triglycerides will be analyzed from venous blood by an accredited medical laboratory
Time Frame
Baseline and 4 and 8 months
Title
Change in Fasting Low Density Lipoprotein Cholesterol (LDL-C)
Description
Fasting LDL-C will be analyzed from venous blood by an accredited medical laboratory
Time Frame
Baseline and 4 and 8 months
Title
Change in Fasting High Density Lipoprotein Cholesterol (HDL-C)
Description
Fasting HDL-C will be analyzed from venous blood by an accredited medical laboratory
Time Frame
Baseline and 4 and 8 months
Title
Change in Fasting Total Cholesterol
Description
Fasting total cholesterol will be analyzed from venous blood by an accredited medical laboratory
Time Frame
Baseline and 4 and 8 months
Title
Change in Proportion of Metabolic Syndrome Diagnosis
Description
Metabolic syndrome diagnosis will be evaluated with waist circumference, triglycerides, HDL-C, blood pressure, and fasting glucose
Time Frame
Baseline and 4 and 8 months
Title
Number of Adverse Events
Description
Adverse events related or unrelated to training will be assessed
Time Frame
Baseline and 4 and 8 months
Title
Change in Organ Fat
Description
Organ fat will be assessed using magnetic resonance imaging (MRI)
Time Frame
Baseline and 4 and 8 months
Title
Change in SF-12 Physical Component Summary Score
Description
Physical health-related quality of life will be assessed using the Physical Component Summary Score of the 12-Item Short-Form Health Survey (SF-12)
Time Frame
Baseline and 4 and 8 months
Title
Change in SF-12 Mental Component Summary Score
Description
Mental health-related quality of life will be assessed using the Mental Component Summary Score of the 12-Item Short-Form Health Survey (SF-12)
Time Frame
Baseline and 4 and 8 months
Title
Change in HADS-D Score
Description
HADS-D score will be assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Time Frame
Baseline and 4 and 8 months
Title
Change in PHQ-9 Score
Description
PHQ-9 score will be assessed using the Patient Health Questionnaire-9 (PHQ-9)
Time Frame
Baseline and 4 and 8 months
Title
Change in HADS-A Score
Description
HADS-A score will be assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Time Frame
Baseline and 4 and 8 months
Title
Change in GAD-7 Score
Description
GAD-7 score will be assessed using the General Anxiety Disorder-7 (GAD-7) Questionnaire
Time Frame
Baseline and 4 and 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parco M. Siu, PhD
Phone
+852 2831 5262
Email
pmsiu@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parco M. Siu, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKS Faculty of Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chit-Kay Leung, BSc
Phone
(852) 28315291
Email
lchitkay@connect.hku.hk
First Name & Middle Initial & Last Name & Degree
Chit-Kay Leung, BSc
First Name & Middle Initial & Last Name & Degree
Joshua Bernal, BSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 3 months and ending 3 years following the publication of the article.
IPD Sharing 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.

Learn more about this trial

Optimal Frequency of High-Intensity Interval Training for Centrally Obese Adults

We'll reach out to this number within 24 hrs