NCT07002970

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

May 23, 2025

Last Update Submit

May 31, 2025

Conditions

Obesity

Keywords

aerobic exerciseinflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Short Form Quality of Life Questionnaire (SF-36)

    To measure the health related quality of life (HRQOL)in obese patient. SF-36 (version 2.0) is a 36-item measure of generic HRQOL in which 35 questions are transformed into eight dimensions; physical functioning, role limitation to physical problems, bodily pain, general health, vitality, social functioning, role limitations to emotional problems, and mental health Scores on all eight dimensions range from zero to 100, where higher scores represent better HRQOL

    12 weeks

Secondary Outcomes (5)

  • Laboratory Measurements

    12 weeks

  • Blood Pressure Measures

    12 weeks

  • body weight

    12 weeks

  • height

    12 weeks

  • waist and hip circumferences

    12 weeks

Study Arms (2)

study group

EXPERIMENTAL

aerobic exercise program and Mediterranean diet

Other: aerobic exercise programOther: Mediterranean diet

control group

ACTIVE COMPARATOR

Mediterranean diet

Other: Mediterranean diet

Interventions

aerobic exercise programOTHER

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

study group
Mediterranean dietOTHER

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

control groupstudy group

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • mai salah, master

    faculty of physical Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 4, 2025

Study Start

October 1, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations

EG(1)