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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Once-Weekly HIIT
* Behavioral: Thrice-Weekly HIIT
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once-Weekly HIIT<br>Once-weekly HIIT for 16 weeks, led by certified athletic coaches | Behavioral: Once-Weekly HIIT<br>* 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.<br>|
| Experimental: Thrice-Weekly HIIT<br>Thrice-weekly HIIT for 16 weeks, led by certified athletic coaches | Behavioral: Thrice-Weekly HIIT<br>* 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.<br>|
| Other: Usual Care<br>Bi-weekly health education, led by research personnel | Other: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Fat | Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA) | Baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Fat | Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA) | Baseline and 8 months | 
| Change in Abdominal Visceral Fat | Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI) | Baseline and 4 and 8 months | 
| Change in Abdominal Subcutaneous Fat | Abdominal subcutaneous fat will be assessed using magnetic resonance imaging (MRI) | Baseline and 4 and 8 months | 
| Change in Body Mass Index | Weight and height will be assessed using a calibrated electronic digital weighing scale and stadiometer respectively | Baseline and 4 and 8 months | 
| Change in Waist Circumference | Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1cm on bare skin | Baseline and 4 and 8 months | 
| Change in Systolic Blood Pressure | Resting systolic blood pressure will be assessed | Baseline and 4 and 8 months | 
| Change in Diastolic Blood Pressure | Resting diastolic blood pressure will be assessed | Baseline and 4 and 8 months | 
| Change in Fasting Glucose | Fasting glucose will be analyzed from venous blood by an accredited medical laboratory | Baseline and 4 and 8 months | 
| Change in Fasting Triglycerides | Fasting triglycerides will be analyzed from venous blood by an accredited medical laboratory | Baseline and 4 and 8 months | 
| Change in Fasting Low Density Lipoprotein Cholesterol (LDL-C) | Fasting LDL-C will be analyzed from venous blood by an accredited medical laboratory | Baseline and 4 and 8 months | 
| Change in Fasting High Density Lipoprotein Cholesterol (HDL-C) | Fasting HDL-C will be analyzed from venous blood by an accredited medical laboratory | Baseline and 4 and 8 months | 
| Change in Fasting Total Cholesterol | Fasting total cholesterol will be analyzed from venous blood by an accredited medical laboratory | Baseline and 4 and 8 months | 
| Change in Proportion of Metabolic Syndrome Diagnosis | Metabolic syndrome diagnosis will be evaluated with waist circumference, triglycerides, HDL-C, blood pressure, and fasting glucose | Baseline and 4 and 8 months | 
| Number of Adverse Events | Adverse events related or unrelated to training will be assessed | Baseline and 4 and 8 months | 
| Change in Organ Fat | Organ fat will be assessed using magnetic resonance imaging (MRI) | Baseline and 4 and 8 months | 
| 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) | Baseline and 4 and 8 months | 
| 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) | Baseline and 4 and 8 months | 
| Change in HADS-D Score | HADS-D score will be assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) | Baseline and 4 and 8 months | 
| Change in PHQ-9 Score | PHQ-9 score will be assessed using the Patient Health Questionnaire-9 (PHQ-9) | Baseline and 4 and 8 months | 
| Change in HADS-A Score | HADS-A score will be assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) | Baseline and 4 and 8 months | 
| Change in GAD-7 Score | GAD-7 score will be assessed using the General Anxiety Disorder-7 (GAD-7) Questionnaire | Baseline and 4 and 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Central Obesity, High-Intensity Interval Training, Aerobic Exercise, Adults, Metabolic Syndrome