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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04887454
• Other study ID #: 1v3HIIT
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: The University of Hong Kong
• Contact: Parco M. Siu, PhD
• Phone: +852 2831 5262
• Email: pmsiu[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
Hong Kong	LKS Faculty of Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Fat	Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)	Baseline and 4 months
Secondary	Change in Body Fat	Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DXA)	Baseline and 8 months
Secondary	Change in Abdominal Visceral Fat	Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI)	Baseline and 4 and 8 months
Secondary	Change in Abdominal Subcutaneous Fat	Abdominal subcutaneous fat will be assessed using magnetic resonance imaging (MRI)	Baseline and 4 and 8 months
Secondary	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
Secondary	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
Secondary	Change in Systolic Blood Pressure	Resting systolic blood pressure will be assessed	Baseline and 4 and 8 months
Secondary	Change in Diastolic Blood Pressure	Resting diastolic blood pressure will be assessed	Baseline and 4 and 8 months
Secondary	Change in Fasting Glucose	Fasting glucose will be analyzed from venous blood by an accredited medical laboratory	Baseline and 4 and 8 months
Secondary	Change in Fasting Triglycerides	Fasting triglycerides will be analyzed from venous blood by an accredited medical laboratory	Baseline and 4 and 8 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Adverse Events	Adverse events related or unrelated to training will be assessed	Baseline and 4 and 8 months
Secondary	Change in Organ Fat	Organ fat will be assessed using magnetic resonance imaging (MRI)	Baseline and 4 and 8 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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