Interval Training and Cardio-metabolic Health in Overweight/Obese Girls

July 31, 2024 updated by: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Impact of Different Interval Training Protocols on Physical, Cardio-metabolic, Lipidomic, Hematological and Psychological Parameters in Young Overweight/Obese Girls

The main purpose of this study is to compare the impact of 12-week moderate-intensity interval training (MIIT) versus combined MIIT with high-intensity interval training (HIIT) on physical fitness, cardio metabolic, lipidomic, hematological and psychological characteristics in young overweight/obese girls.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1007
        • Recruiting
        • ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
        • Contact:
        • Contact:
      • Tunis, Tunisia, 1007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female gender,
  • Overweight or obese according to the BMI classification,
  • Age, 12 to 15 years,
  • Personal or parental/guardian written consent

Exclusion Criteria:

  • Severe infectious or inflammatory diseases,
  • Irregular menstrual cycles
  • Participation in organized exercise training in the last 6 months or additional physical -
  • recreational activities, except physical education classes.
  • Using medications, hormone therapy or dietary supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIIT
12-week supervised exercise program consisting of moderate -intensity interval training (MIIT)
Other: MIIT

12-week supervised exercise program consisting of moderate-intensity interval training (MIIT)

MIIT: 3 series of 4-8 repetitions of 30-s of work at 70-75% of MAS and 30-s of active recovery at 50% of MAS.

3 exercise sessions per week.

Additionally, participants receive no individualized nutritional counseling.
Active Comparator: MIIT+ HIIT
12-week supervised exercise program consisting of moderate-intensity interval training (MIIT) (6-week) and high-intensity interval training (HIIT) (6-week).
Other: MIIT + HIIT

12-week supervised exercise program consisting of moderate-intensity interval training (MIIT) (6-week) and high-intensity interval training (HIIT) (6-week).

MIIT: 3 series of 4-8 repetitions of 30-s of work at 70-75% of MAS and 30-s of active recovery at 50% of MAS.

HIIT: 3 series of 5 repetitions of 30-s of work at 100% of MAS and 30-s of active recovery at 50% of MAS for weeks 7-9, as well as two series of 10 repetitions of 30-s of work at 100% of MAS and 30-s of active recovery at 50% of MAS for weeks 10-12.

3 exercise sessions per week. Additionally, participants receive no individualized nutritional counseling.
Placebo Comparator: Control group No training
Other: Control group

Habitual physical activity No additional physical intervention

Additionally, participants receive no individualized nutritional counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index (BMI)
Time Frame: 12 weeks
measures of weight in kilograms, height in meters, calculation of BMI in kg/m^2)
12 weeks
Changes in plasma triglycerides
Time Frame: 12 weeks
will be assessed using an Alinity-Abbott autoanalyzer
12 weeks
Enjoyment
Time Frame: 6 and 12 weeks
Enjoyment will be measured using the validated Physical Activity Enjoyment Scale. This scale was used to assess the level of enjoyment following interventions using the participants' responses to 18 items rated on a 7-point bipolar rating scale. The assessment consists of questions relateding to the enjoyment after intervention with the instruction, "Please rate how you feel about the physical activity you have been doing at the moment about the physical activity you have been doing". An overallOverall enjoyment of physical activity score was generated by summing the individual item scores. Scores ranged from 18-126, with higher scores reflecting higher levels of enjoyment.
6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Aerobic velocity
Time Frame: 6 and 12 weeks
Aerobic velocity will be measured with incremental running test "the Spartacus test". This test is validated for the evaluation of aerobic capacity for obese adolescents. A rectangle of 750 m (75 × 10 m) will be created with different marks set at regular intervals, which represent the different speeds (from 7 to 18 km/h). Each stage lasts three minutes whereby the first stage is set at 7 km/h and each following stage increasing by 1 km/h. During each stage, the participant had 15 s to reach the corresponding mark and then 15 s of rest. Participants adjusted their running speed simultaneously to cones and audio beep. The test ended when the subject was no longer able to maintain the pace for two consecutive occasions or when he decided to stop due to exhaustion.
6 and 12 weeks
Changes in lipidomic profile
Time Frame: 12 weeks
Lipidomic profile will be assessed by measuring selected plasma polyunsaturated fatty acids (PUFAs), oxylipins and endocabnnabinnoids by LC-MS/MS method
12 weeks
Changes in hematological parameters
Time Frame: 12 weeks
Hematological parameters included red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, leukocyte count , neutrophil count , lymphocyte count, monocyte count , eosinophil count and platelet count will be measured using an automated cell counter (Sysmex XN450; Norderstedt, Germany).
12 weeks
Change in Heart rate
Time Frame: 12 weeks
Heart rate will be recorded using a heart rate monitor (S810, Polar, Kempele, Finland) during the incremental running test "the Spartacus test".
12 weeks
Change in sprint performance
Time Frame: 12 weeks
Sprinting performance will be evaluated by 10-m, 20-m, 30 --m and 60-m sprints, using a series of paired photocells with an accuracy of 0.01 s (Brower Timing System, Salt Lake City, UT).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Actual)

June 20, 2024

Study Completion (Estimated)

August 19, 2024

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERB 16/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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