NCT04860349

Brief Summary

Overweight is a risk factor for a number of non-communicable diseases, and this risk doubles, if an individual is physically inactive. Various exercise interventional protocols in the past have been reported on treating overweight and obesity which helps to decrease the different anthropometric variables. Despite all these protocols, obese and overweight do not seem to benefit greatly by these exercise training programs, as lack of time is thought to the main reason for not engaging in healthful physical exercise. Research evidence has proven that people with a body mass index of more than 30 kg/m2 and waist circumference of more than 102 cm have 2-fold higher risk of waking fewer steps daily. Although physical exercise is thought to be very helpful in regulating the body weight, it is very important to identify the type of physical activity to effectively manage overweight and obesity. Aerobic exercise namely high intensity interval training have been reported to reduce the body mass, fat%, and waist circumference. Investigators believe that high intensity interval training would help in controlling the various anthropometric variables namely the body mass index, waist circumference, and fat% in trunk region in physically inactive overweight adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

May 14, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

April 16, 2021

Last Update Submit

December 16, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Body Mass Index

    Change from Baseline Body Mass Index at 4 weeks

  • Waist Circumference

    Change from Baseline Waist Circumference at 4 weeks

  • Fat Percentage at Trunk Region

    Change from Baseline Fat Percentage at Trunk Region at 4 weeks

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

20 minutes of High Intensity Interval Training for experimental group.

Other: High Intensity Interval Training

Control

NO INTERVENTION

No intervention for the control group.

Interventions

4-weeks of high intensity interval training, 3 sessions/week on alternate days. each session for 20 minutes, excluding the warm-up and cool-down.

High Intensity Interval Training

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Either gender
  • Aged 18-25 years
  • Physically Inactive

You may not qualify if:

  • Any medical condition that restrict the participants to participate in physical exercise
  • Blood pressure of more than 140/90 mmHg
  • Participants taking any medication that causes drowsiness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Tunku Abdul Rahman

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Overweight

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 26, 2021

Study Start

May 14, 2021

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Locations