Effect of Aerobic Exercise and Mediterranean Diet on Obese Patients

NCT ID: NCT07002970

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-05-01

Brief Summary

All study group patients performed aerobic exercise on a treadmill. approved by the American College of Sports Medicine.

Both groups received a Mediterranean diet for 12 weeks tailored according to patients' caloric needs

Detailed Description

All study group patients performed aerobic exercise on a treadmill approved by the American College of Sports Medicine. The program started with a warming-up phase through walking on a treadmill for 3-5 minutes at a slow speed. Then, 10-30 minutes of aerobic exercise training with moderate intensity (60-70% of maximum heart rate) and 10 minutes of cooling down with low speed and without inclination. Participants had 3 sessions/week for 3 months with close supervision of a physical therapist.

Both groups received a Mediterranean diet for 12 weeks tailored to patients' caloric needs. They received instructions about the consumption of olive oil as added lipid, the consumption of nuts and olives as snacks, daily high consumption of vegetables, fruits, and whole grains, dairy products, bi-weekly consumption of legumes, bi-weekly consumption of fish, and monthly consumption of meat. The main beneficial components of the Mediterranean diet are monounsaturated fats such as oleic acid in olive oil, polyunsaturated fats such as omega-3, high amounts of flavonoids and antioxidants found in fruits and vegetables, and high amounts of fiber found mainly in foods with a low glycemic index

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

study group

aerobic exercise program and Mediterranean diet

Group Type: EXPERIMENTAL

aerobic exercise program

Intervention Type: OTHER

All study group patients performed aerobic exercise on a treadmill. approved by the American College of Sports Medicine.

Mediterranean diet

Intervention Type: OTHER

received a Mediterranean diet for 12 weeks tailored according to patients caloric needs

control group

Mediterranean diet

Group Type: ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type: OTHER

received a Mediterranean diet for 12 weeks tailored according to patients caloric needs

Interventions

aerobic exercise program

All study group patients performed aerobic exercise on a treadmill. approved by the American College of Sports Medicine.

Intervention Type: OTHER

Mediterranean diet

received a Mediterranean diet for 12 weeks tailored according to patients caloric needs

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Obese patients with BMI ranged from 30-39.9 kg/m 2.
• Their age was from 35 to 45 years old.
• Both genders.
• Stable vital signs (blood pressure, respiratory rate and temperature)
• Abdominal obesity measurements according to American heart association)
• Obese patients have one or more abnormal value of lipids profile.
• All patients with sedentary life style.
• All patients had insulin resistance

Exclusion Criteria

• Rheumatic, neurologic, cardiovascular, respiratory, renal, lung problems, malignant tumors, and undiagnosed fever, which would prevent them from participating in aerobic exercises.
• Knee injury or knee surgery during the past six month or having a history of joint replacement or fracture or hereditary or acquired musculoskeletal disorders in lower limb.
• Major vision disorders.
• Drugs that would affect metabolism or balance.
• Assistive devices for walking.
• Pregnancy or breast feeding, and post-partum 12 months.
• Abdominal or rectal anus surgery.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Salah

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mai salah, master

Role: PRINCIPAL_INVESTIGATOR

faculty of physical Cairo university

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004630

Identifier Type: -

Identifier Source: org_study_id