NCT06664398

Brief Summary

This study investigates the effects of different volumes of high-intensity interval training on risk factors for metabolic syndrome in overweight young women.

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 Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 28, 2024

Last Update Submit

October 28, 2024

Conditions

Keywords

high-intensity interval trainingoverweightmetabolic syndromerisk factorprevention

Outcome Measures

Primary Outcomes (9)

  • Weight

    Changes in Weight before and after intervention.

    8 weeks

  • Body Mass Index (BMI)

    Changes in BMI before and after intervention.

    8 weeks

  • body fat percentage

    Changes in body fat percentage before and after intervention.

    8 weeks

  • waist circumference (WC)

    Changes in WC before and after intervention.

    8 weeks

  • Systolic blood pressure (SBP)

    Changes in SBP before and after intervention.

    8 weeks

  • Diastolic blood pressure (DBP)

    Changes in DBP before and after intervention.

    8 weeks

  • Fasting plasma glucose (FPG)

    Changes in FPG before and after intervention.

    8 weeks

  • Triglyceride (TG)

    Changes in TG before and after intervention.

    8 weeks

  • High-density lipoprotein cholesterol (HDL-C)

    Changes in HDL-C before and after intervention.

    8 weeks

Secondary Outcomes (6)

  • Non high-density lipoprotein cholesterol (Non HDL-C)

    8 weeks

  • Insulin

    8 weeks

  • Homeostatic model assessment for insulin resistance (HOMA-IR)

    8 weeks

  • Triglyceride-glucose (TyG) index

    8 weeks

  • Triglyceride-to-high density lipoprotein cholesterol ratio (TG/HDL-C ratio)

    8 weeks

  • +1 more secondary outcomes

Study Arms (3)

1HIIT group

ACTIVE COMPARATOR
Behavioral: one HIIT

4HIIT group

ACTIVE COMPARATOR
Behavioral: four HIIT

Control group

NO INTERVENTION

Interventions

one HIITBEHAVIORAL

one HIIT high intensity interval training

1HIIT group
four HIITBEHAVIORAL

four HIIT high intensity interval training

4HIIT group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-30 years;
  • BMI≥24kg/m2, indicating overweight and high risk of metabolic syndrome;
  • Maintaining a stable body weight for the three months prior to the study.

You may not qualify if:

  • Regular participation in physical exercise (≥3 times/week, exercise time≥30min/time);
  • Any respiratory, musculoskeletal, or cardiovascular diseases;
  • Medical or other contraindications for exercise;
  • Taking medications that affect metabolism;
  • Smoking and/or drinking habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

Location

MeSH Terms

Conditions

Metabolic SyndromeOverweight

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 29, 2024

Study Start

April 14, 2021

Primary Completion

July 30, 2021

Study Completion

November 30, 2021

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations