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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Thrice-Weekly HIIT; Behavioral: Once-Weekly HIIT; Other: Usual Care

• Registration Number: NCT04887454
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-14
• Study Start: 2021-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 315

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thrice-Weekly HIIT	Thrice-Weekly HIIT	Thrice-weekly HIIT for 16 weeks, led by certified athletic coaches
Once-Weekly HIIT	Once-Weekly HIIT	Once-weekly HIIT for 16 weeks, led by certified athletic coaches
Usual Care	Usual Care	Bi-weekly health education, led by research personnel

Primary Outcome Measures

Name	Time	Method
Change in Body Fat	Baseline and 4 months	Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)

Secondary Outcome Measures

Name	Time	Method
Change in Body Mass Index	Baseline and 4 and 8 months	Weight and height will be assessed using a calibrated electronic digital weighing scale and stadiometer respectively
Change in Body Fat	Baseline and 8 months	Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)
Change in Abdominal Visceral Fat	Baseline and 4 and 8 months	Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI)
Change in Fasting Low Density Lipoprotein Cholesterol (LDL-C)	Baseline and 4 and 8 months	Fasting LDL-C will be analyzed from venous blood by an accredited medical laboratory
Change in Fasting Total Cholesterol	Baseline and 4 and 8 months	Fasting total cholesterol will be analyzed from venous blood by an accredited medical laboratory
Change in Proportion of Metabolic Syndrome Diagnosis	Baseline and 4 and 8 months	Metabolic syndrome diagnosis will be evaluated with waist circumference, triglycerides, HDL-C, blood pressure, and fasting glucose
Change in Diastolic Blood Pressure	Baseline and 4 and 8 months	Resting diastolic blood pressure will be assessed
Change in Fasting Glucose	Baseline and 4 and 8 months	Fasting glucose will be analyzed from venous blood by an accredited medical laboratory
Number of Adverse Events	Baseline and 4 and 8 months	Adverse events related or unrelated to training will be assessed
Change in Abdominal Subcutaneous Fat	Baseline and 4 and 8 months	Abdominal subcutaneous fat will be assessed using magnetic resonance imaging (MRI)
Change in Systolic Blood Pressure	Baseline and 4 and 8 months	Resting systolic blood pressure will be assessed
Change in Fasting High Density Lipoprotein Cholesterol (HDL-C)	Baseline and 4 and 8 months	Fasting HDL-C will be analyzed from venous blood by an accredited medical laboratory
Change in PHQ-9 Score	Baseline and 4 and 8 months	PHQ-9 score will be assessed using the Patient Health Questionnaire-9 (PHQ-9)
Change in HADS-A Score	Baseline and 4 and 8 months	HADS-A score will be assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Change in Organ Fat	Baseline and 4 and 8 months	Organ fat will be assessed using magnetic resonance imaging (MRI)
Change in Waist Circumference	Baseline and 4 and 8 months	Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1cm on bare skin
Change in SF-12 Physical Component Summary Score	Baseline and 4 and 8 months	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	Baseline and 4 and 8 months	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	Baseline and 4 and 8 months	HADS-D score will be assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Change in GAD-7 Score	Baseline and 4 and 8 months	GAD-7 score will be assessed using the General Anxiety Disorder-7 (GAD-7) Questionnaire
Change in Fasting Triglycerides	Baseline and 4 and 8 months	Fasting triglycerides will be analyzed from venous blood by an accredited medical laboratory

Trial Locations

Locations (1)

LKS Faculty of Medicine; 🇭🇰 Hong Kong, Hong Kong