Clinical trial NCT04887454: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Central Obesity
High-Intensity Interval Training
Aerobic Exercise
Adults
Metabolic Syndrome
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Body Fat
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change in Body Fat
timeFrame: Baseline and 8 months
measure: Change in Abdominal Visceral Fat
timeFrame: Baseline and 4 and 8 months
measure: Change in Abdominal Subcutaneous Fat
timeFrame: Baseline and 4 and 8 months
measure: Change in Body Mass Index
timeFrame: Baseline and 4 and 8 months
measure: Change in Waist Circumference
timeFrame: Baseline and 4 and 8 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 4 and 8 months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and 4 and 8 months
measure: Change in Fasting Glucose
timeFrame: Baseline and 4 and 8 months
measure: Change in Fasting Triglycerides
timeFrame: Baseline and 4 and 8 months
measure: Change in Fasting Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline and 4 and 8 months
measure: Change in Fasting High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline and 4 and 8 months
measure: Change in Fasting Total Cholesterol
timeFrame: Baseline and 4 and 8 months
measure: Change in Proportion of Metabolic Syndrome Diagnosis
timeFrame: Baseline and 4 and 8 months
measure: Number of Adverse Events
timeFrame: Baseline and 4 and 8 months
measure: Change in Organ Fat
timeFrame: Baseline and 4 and 8 months
measure: Change in SF-12 Physical Component Summary Score
timeFrame: Baseline and 4 and 8 months
measure: Change in SF-12 Mental Component Summary Score
timeFrame: Baseline and 4 and 8 months
measure: Change in HADS-D Score
timeFrame: Baseline and 4 and 8 months
measure: Change in PHQ-9 Score
timeFrame: Baseline and 4 and 8 months
measure: Change in HADS-A Score
timeFrame: Baseline and 4 and 8 months
measure: Change in GAD-7 Score
timeFrame: Baseline and 4 and 8 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: LKS Faculty of Medicine
Study officials:
affiliation: The University of Hong Kong
name: Parco M. Siu, PhD
role: PRINCIPAL_INVESTIGATOR
References: