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NCT Number: NCT06538714

Interval Training and Cardio-metabolic Health in 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.

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Key information

Age range

12 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIIT

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

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

Other

Habitual physical activity No additional physical intervention

Additionally, participants receive no individualized nutritional counseling.

Primary outcomes

  1. 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)

  2. Changes in plasma triglycerides

    Time frame: 12 weeks

    will be assessed using an Alinity-Abbott autoanalyzer

  3. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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".

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Amani Kallel, PhD

CONTACT

[email protected]

96872787 ext. 216

Moncef Feki, MD

CONTACT

[email protected]

95802073 ext. 216

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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