NCT07283406

Brief Summary

The objective of the present project is to compare the effects of two types of training on cardiovascular health components and physical fitness in young adults with obesity.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

November 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

January 3, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

12 days

First QC Date

November 13, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

obesityHIITMICT

Outcome Measures

Primary Outcomes (16)

  • Maximum oxygen uptake (VO₂max)

    VO₂max (ml/min/kg): Change from Baseline at 12 weeks, measured using a submaximal exercise test based on the Åstrand-Ryhming protocol

    Baseline and after 12 weeks

  • Weight

    Weight (kg): Changes in weight from baseline to 12 weeks of intervention.

    Baseline and after 12 weeks

  • Height

    Height (cm): Changes in height from baseline to 12 weeks of intervention.

    Baseline and after 12 weeks

  • Body mass index (BMI)

    BMI (kg/m2): Change from Baseline at 12 weeks, calculated by: weight (kg)/ height (m\^2)

    Baseline and after 12 weeks

  • Body fat percentage

    Body fat percentage (%): Changes in body fat assessed by bioelectrical impedance analysis (BIA)

    Baseline and after 12 weeks

  • Muscle mass percentage

    Muscle mass percentage (%): Changes in muscle mass measured using bioelectrical impedance analysis (BIA)

    Baseline and after 12 weeks

  • Waist circumference

    Waist circumference (cm): Changes in waist circumference will be measured using a Lufkin measuring tape (USA) following the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK)

    Baseline and after 12 weeks

  • Waist-to-hip ratio

    Waist-to-hip ratio: Changes in waist-to-hip ratio will be calculated by dividing the waist measurement by the hip measurement

    Baseline and after 12 weeks

  • Glucose

    Glucose (mg/dl): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

  • Triglycerides

    Triglycerides (mg/dl): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

  • Total cholesterol

    Total cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

  • HDL cholesterol

    HDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

  • LDL cholesterol

    LDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

  • C-reactive protein (CRP)

    CRP (mg/dl): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

  • Systolic blood pressure (SBP)

    SBP (mmHg): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

  • Diastolic blood pressure (DBP)

    DBP (mmHg): Changes from baseline to 12 weeks of intervention

    Baseline and after 12 weeks

Study Arms (2)

HIIT Group

EXPERIMENTAL

This group will train for 12 weeks

Other: High-intensity interval training interventionOther: Educational sessions

MICT Group

ACTIVE COMPARATOR

This group will train for 12 weeks

Other: Moderate-intensity continuous training interventionOther: Educational sessions

Interventions

The HIIT group will undergo training for 12 weeks, with a frequency of three sessions per week, completing a total of 36 sessions. Each session will include a 5-minute warm-up and a 5-minute cool-down at 50-60% of maximum heart rate (HRmax). The training protocol will consist of 2-minute high-intensity intervals performed at 90-95% HRmax, corresponding to a Borg rating of perceived exertion (RPE) of 17-18, alternated with 2-minute recovery periods at 70% HRmax (RPE 12-14). A total of five intervals will be completed per session, resulting in an overall high-intensity workload of 18 minutes. All training sessions will be conducted on a stationary cycle ergometer

HIIT Group

The MICT group will perform moderate-intensity continuous training at 60-70% HRmax, corresponding to an RPE of 12-14, for 35-45 minutes on a stationary cycleergometer. Heart rate and physical activity levels will be continuously monitored in both groups using a chest-strap heart rate sensor (Polar H9, Polar Electro, Finland).

MICT Group

In addition, four educational sessions will be conducted to provide dietary recommendations to all participants. These sessions will aim to promote balanced eating habits and to discourage the excessive consumption of ultra-processed foods or alcohol, as these factors could interfere with the intervention outcomes.

HIIT GroupMICT Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults
  • BMI ≥ 30 kg/m\^2" and \< 40 kg/m\^2
  • Signed informed consent form

You may not qualify if:

  • Participants who smoke
  • Clinical diagnosis of hypothyroidism
  • Clinical diagnosis of type 1 diabetes mellitus
  • Clinical diagnosis of type 2 diabetes mellitus
  • Clinical diagnosis of grade 3 obesity
  • Clinical diagnosis of hypertension
  • Clinical diagnosis of acute myocardial infarction or angina pectoris
  • Use of nitrates and calcium channel blockers within 4 days prior to the start of the study
  • Use of beta-blockers or hypoglycemic agents within 7 days prior to the intervention
  • Pregnant women
  • Breastfeeding women
  • Men consuming more than 40 g of alcohol per day or women consuming more than 20 g per day
  • Postural and biomechanical disorders (knee, foot, and spine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitario de Tlajomulco, Universidad de Guadalajara

Guadalajara, Jalisco, 45650, Mexico

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2025

First Posted

December 15, 2025

Study Start

January 3, 2026

Primary Completion

January 15, 2026

Study Completion

April 1, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations