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Clinical Trials/NCT04887454
NCT04887454CompletedNot Applicable

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

The University of Hong Kong1 site in 1 country315 target enrollmentStarted: September 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
315
Locations
1
Primary Endpoint
Change in Body Fat

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Once-Weekly HIIT

Experimental

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

Intervention: Once-Weekly HIIT (Behavioral)

Thrice-Weekly HIIT

Experimental

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

Intervention: Thrice-Weekly HIIT (Behavioral)

Usual Care

Other

Bi-weekly health education, led by research personnel

Intervention: Usual Care (Other)

Outcomes

Primary Outcomes

Change in Body Fat

Time Frame: Baseline and 4 months

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

Secondary Outcomes

  • Change in Body Mass Index(Baseline and 4 and 8 months)
  • Change in Diastolic Blood Pressure(Baseline and 4 and 8 months)
  • Change in Fasting Glucose(Baseline and 4 and 8 months)
  • Change in Fasting High Density Lipoprotein Cholesterol (HDL-C)(Baseline and 4 and 8 months)
  • Change in Body Fat(Baseline and 8 months)
  • Change in Abdominal Visceral Fat(Baseline and 4 and 8 months)
  • Change in Fasting Low Density Lipoprotein Cholesterol (LDL-C)(Baseline and 4 and 8 months)
  • Change in Fasting Total Cholesterol(Baseline and 4 and 8 months)
  • Change in Proportion of Metabolic Syndrome Diagnosis(Baseline and 4 and 8 months)
  • Number of Adverse Events(Baseline and 4 and 8 months)
  • Change in Abdominal Subcutaneous Fat(Baseline and 4 and 8 months)
  • Change in Systolic Blood Pressure(Baseline and 4 and 8 months)
  • Change in PHQ-9 Score(Baseline and 4 and 8 months)
  • Change in HADS-A Score(Baseline and 4 and 8 months)
  • Change in Organ Fat(Baseline and 4 and 8 months)
  • Change in Waist Circumference(Baseline and 4 and 8 months)
  • Change in SF-12 Physical Component Summary Score(Baseline and 4 and 8 months)
  • Change in SF-12 Mental Component Summary Score(Baseline and 4 and 8 months)
  • Change in HADS-D Score(Baseline and 4 and 8 months)
  • Change in GAD-7 Score(Baseline and 4 and 8 months)
  • Change in Fasting Triglycerides(Baseline and 4 and 8 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Parco M. Siu, PhD

Associate Professor and Division Head

The University of Hong Kong

Study Sites (1)

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