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

Sponsor

The University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT04887454

Collaborator

(none)

315

Enrollment

Location

Arms

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Once-Weekly HIIT Behavioral: Thrice-Weekly HIIT Other: Usual Care	N/A

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

Anticipated Enrollment :

315 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Once-Weekly HIIT

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

Behavioral: Once-Weekly HIIT

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.

Experimental: Thrice-Weekly HIIT

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

Behavioral: Thrice-Weekly HIIT

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.

Other: Usual Care

Bi-weekly health education, led by research personnel

Other: Usual Care

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.

Outcome Measures

Primary Outcome Measures

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

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 Abdominal Subcutaneous Fat [Baseline and 4 and 8 months]
Abdominal subcutaneous fat will be assessed using magnetic resonance imaging (MRI)
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 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 Systolic Blood Pressure [Baseline and 4 and 8 months]
Resting systolic blood pressure will be assessed
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
Change in Fasting Triglycerides [Baseline and 4 and 8 months]
Fasting triglycerides will be analyzed from venous blood by an accredited medical laboratory
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 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 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
Number of Adverse Events [Baseline and 4 and 8 months]
Adverse events related or unrelated to training will be assessed
Change in Organ Fat [Baseline and 4 and 8 months]
Organ fat will be assessed using magnetic resonance imaging (MRI)
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 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 GAD-7 Score [Baseline and 4 and 8 months]
GAD-7 score will be assessed using the General Anxiety Disorder-7 (GAD-7) Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)