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

NCT ID: NCT06538714

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2024-08-19

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise Overtraining Enjoyment Cardiometabolic Syndrome Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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MIIT

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

Group Type EXPERIMENTAL

MIIT

Intervention Type OTHER

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.

MIIT+ HIIT

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

Group Type ACTIVE_COMPARATOR

MIIT + HIIT

Intervention Type OTHER

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.

Control group No training

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

Habitual physical activity No additional physical intervention

Additionally, participants receive no individualized nutritional counseling.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Control group

Habitual physical activity No additional physical intervention

Additionally, participants receive no individualized nutritional counseling.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Tunis, , Tunisia

Site Status RECRUITING

Rabta Hospital

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Amani Kallel, PhD

Role: CONTACT

96872787 ext. 216

Moncef Feki, MD

Role: CONTACT

95802073 ext. 216

Facility Contacts

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Amani Kallel, PhD

Role: primary

+21696872787

Riadh Jemaa, PhD

Role: backup

+21698819168

Amani Kallel, PhD

Role: primary

96872787 ext. 216

Other Identifiers

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CERB 16/2024

Identifier Type: -

Identifier Source: org_study_id

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