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

NCT06538714 | Recruiting

• 1 other identifier: CERB 16/2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Exercise Overtraining; Enjoyment; Cardiometabolic Syndrome; Obesity

Keywords

interval training; obesity; overweight; childhood; cardiometabolic risk; enjoyement; lipidomics; body composition; physical fitness

Outcome Measures

Primary Outcomes (3)

• Change in body mass index (BMI)

  measures of weight in kilograms, height in meters, calculation of BMI in kg/m\^2)

  12 weeks

• Changes in plasma triglycerides

  will be assessed using an Alinity-Abbott autoanalyzer

  12 weeks

• Enjoyment

  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 Outcomes (5)

• Changes in Aerobic velocity

  6 and 12 weeks

• Changes in lipidomic profile

  12 weeks

• Changes in hematological parameters

  12 weeks

• Change in Heart rate

  12 weeks

• Change in sprint performance

  12 weeks

Study Arms (3)

MIIT

EXPERIMENTAL

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

Other: MIIT

MIIT+ HIIT

ACTIVE COMPARATOR

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

Control group No training

PLACEBO COMPARATOR

Other: Control group

Interventions

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

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.

MIIT+ HIIT

Control group OTHER

Habitual physical activity No additional physical intervention Additionally, participants receive no individualized nutritional counseling.

Control group No training

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

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

Tunis, 1007, Tunisia

RECRUITING

Rabta Hospital

Tunis, 1007, Tunisia

RECRUITING

MeSH Terms

Conditions

Overtraining Syndrome; Metabolic Syndrome; Obesity; Overweight

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Amani Kallel, PhD

CONTACT

96872787; amani.kallel@fmt.utm.tn

Moncef Feki, MD

CONTACT

95802073; monssef.feki@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: August 6, 2024
• Study Start: May 20, 2024
• Primary Completion: June 20, 2024
• Study Completion: August 19, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-07

Locations

TU (2)