NCT07264348

Brief Summary

This study aims to evaluate the effects of a 4 month Zumba training program on cardiometabolic, hormonal, inflammatory, hepatic, renal, and functional parameters in overweight and obese women. Participants will be classified according to menopausal status (pre- or post-menopausal) and randomly assigned to an exercise group or a non-exercise control group.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

HormoneCardiovascularObesity & Overweight

Keywords

OverweightObesityPre-menopausePost-menopauseZumba TrainingCardiometabolic HealthHormonal AdaptationsLipid Profile

Outcome Measures

Primary Outcomes (40)

  • Body Mass Index (BMI)

    BMI calculated as weight (kg) divided by height squared (m²).

    Baseline and after 4 months of Zumba intervention.

  • Body Fat Percentage

    Total body fat measured by digital scale (Tanita BC-533).

    Baseline and after 4 months of Zumba intervention.

  • Waist Circumference

    Measured at the narrowest point between the rib cage and iliac crest using a tape measure.

    Baseline and after 4 months of Zumba intervention.

  • Waist-Hip Ratio

    Calculated by dividing waist circumference by hip circumference.

    Baseline and after 4 months of Zumba intervention.

  • Hip Circumference

    Measured at the widest point of the hips using a tape measure.

    Baseline and after 4 months of Zumba intervention.

  • Prolactin

    Serum prolactin concentration (ng/mL).

    Baseline and after 4 months of the intervention.

  • Testosterone

    Serum testosterone concentration (ng/dL).

    Baseline and after 4 months of the intervention.

  • Cortisol

    Serum cortisol concentration (µg/dL).

    Baseline and after 4 months of the intervention.

  • Progesterone

    Serum progesterone concentration (ng/mL).

    Baseline and after 4 months of the intervention.

  • Estradiol

    Serum estradiol concentration (pg/mL).

    Baseline and after 4 months of the intervention.

  • Follicle-Stimulating Hormone (FSH)

    Serum FSH concentration (mIU/mL).

    Baseline and after 4 months of the intervention.

  • Luteinizing Hormone (LH)

    Serum LH concentration (mIU/mL).

    Baseline and after 4 months of the intervention.

  • Thyroid Stimulating Hormone (TSH)

    Serum TSH concentration (µIU/mL).

    Baseline and after 4 months of the intervention.

  • Free Thyroxine (FT4)

    Serum free T4 concentration (ng/dL).

    Baseline and after 4 months of the intervention.

  • Parathyroid Hormone (PTH)

    Serum PTH concentration (pg/mL).

    Baseline and after 4 months of the intervention.

  • Total Cholesterol

    Serum total cholesterol concentration (mg/dL).

    Baseline and after 4 months of the intervention.

  • High-Density Lipoprotein (HDL) Cholesterol

    Serum HDL cholesterol concentration (mg/dL).

    Baseline and after 4 months of the intervention.

  • Low-Density Lipoprotein (LDL) Cholesterol

    Serum LDL cholesterol concentration (mg/dL).

    Baseline and after 4 months of the intervention.

  • Triglycerides

    Serum triglyceride concentration (mg/dL).

    Baseline and after 4 months of the intervention.

  • C-Reactive Protein (CRP)

    Serum CRP concentration (mg/L).

    Baseline and after 4 months of the intervention.

  • Erythrocyte Sedimentation Rate (ESR)

    ESR measured in mm/hr.

    Baseline and after 4 months of the intervention.

  • Complete Blood Count (CBC)

    Includes neutrophils, lymphocytes, monocytes, eosinophils, basophils (cells/µL).

    Baseline and after 4 months of the intervention.

  • Alanine Aminotransferase (ALT)

    Serum ALT concentration measured in U/L.

    Baseline and after 4 months of the intervention.

  • Aspartate Aminotransferase (AST)

    Serum AST concentration measured in U/L.

    Baseline and after 4 months of the intervention.

  • Alkaline Phosphatase (ALP)

    Serum ALP concentration measured in U/L.

    Baseline and after 4 months of the intervention.

  • Gamma-Glutamyl Transferase (GGT)

    Serum GGT concentration measured in U/L.

    Baseline and after 4 months of the intervention.

  • Lactate Dehydrogenase (LDH)

    Serum LDH concentration measured in U/L.

    Baseline and after the 4 months of the intervention.

  • Gamma-Glutamyl Transferase (GGT)

    Serum GGT concentration measured in U/L.

    Baseline and after the 4 months of the intervention.

  • Bilirubin Total

    Total serum bilirubin concentration measured in mg/dL.

    Baseline and after the 4 months of the intervention.

  • Bilirubin Direct

    Direct (conjugated) serum bilirubin concentration measured in mg/dL.

    Baseline and after the 4 months of the intervention.

  • Creatinine

    Serum creatinine concentration measured in mg/dL, indicator of kidney function.

    Baseline and after 4 months of the intervention.

  • Urea

    Serum urea concentration measured in mg/dL, indicator of kidney function.

    Baseline and after 4 months of the intervention.

  • Uric Acid

    Serum uric acid concentration measured in mg/dL, indicator of kidney function.

    Baseline and after 4 months of the intervention.

  • Sodium (Na)

    Serum sodium concentration measured in mmol/L.

    Baseline and after 4 months of the intervention.

  • Potassium (K)

    Serum potassium concentration measured in mmol/L.

    Baseline and after 4 months of the intervention.

  • Calcium (Ca)

    Serum calcium concentration measured in mg/dL.

    Baseline and after 4 months of training.

  • Magnesium (Mg)

    Serum magnesium concentration measured in mg/dL.

    Baseline and after 4 months of training.

  • Phosphate (PO₄)

    Serum phosphate concentration measured in mg/dL.

    Baseline and after 4 months of training.

  • Creatine Phosphokinase (CPK)

    Serum CPK concentration measured in U/L, indicator of muscle damage.

    Baseline and after 4 months of training.

  • Lactate Dehydrogenase (LDH)

    Serum LDH concentration measured in U/L, indicator of muscle and tissue damage.

    Baseline and after 4 months of training.

Secondary Outcomes (3)

  • Resting Heart Rate

    Baseline and after 4 months of Zumba intervention.

  • Blood Pressure (Systolic and Diastolic)

    Baseline and after 4 months of Zumba intervention.

  • 6-Minute Walk Test (6MWT) Distance

    Baseline and after 4 months of Zumba intervention.

Study Arms (4)

Experimental Group 1:Pre-menopausal

EXPERIMENTAL

performed Zumba training, 4 × 60 min/week, 4 months

Behavioral: Zumba training

Control Group 1

NO INTERVENTION

No training intervention was intended for the control group.

Experimental Group 2:Post-menopausal

EXPERIMENTAL

performed Zumba training, 4 × 60 min/week, 4 months

Behavioral: Zumba training

Control group 2

NO INTERVENTION

No training intervention was intended for the control group.

Interventions

Zumba trainingBEHAVIORAL

Participants assigned to the experimental groups will perform a supervised Zumba training program for 10 weeks, with 4 sessions per week, each session lasting 60 minutes. Sessions will include a standardized warm-up (10 minutes), choreographed dance-based aerobic sequences performed at moderate intensity (40 minutes), and a cool-down with stretching (10 minutes).

Experimental Group 1:Pre-menopausalExperimental Group 2:Post-menopausal

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, aged 18-65 years
  • BMI ≥ 25 kg/m²
  • Pre-menopausal or post-menopausal (classified clinically)
  • Voluntary written informed consent

You may not qualify if:

  • Hormonal therapy or weight-loss medications
  • Endocrine diseases or chronic illness
  • Recent intense physical training (\<48 hours before baseline)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wissal abassi

    Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wissal Abassi, Dr

CONTACT

+21693304684wissalabassi93@gmail.com

wissal Abassi, Dr

CONTACT

wissalabassi93@gmail.com

Study Design

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

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 4, 2025

Study Start

December 1, 2025

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

For confidentiality reasons, all data from this study will be available upon request.