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NCT Number: NCT06756425

Effect of Aerobic Exercise Program on Blood Glucose Level and Quality of Life in Pre-diabetic Overweight/Obese Adolescents

PURPOSE:

The study aims to:

Investigate the effect of the designed aerobic exercise program on the blood glucose level (fasting blood glucose and HbA1C) in overweight/ obese pre-diabetic adolescents.

2) Investigate the effect of the designed aerobic exercise program on the BMI, aerobic capacity, and waist circumference of the participant before and after the designed aerobic exercise program.

3) Investigate the effect of the designed aerobic exercise program on the quality of life in overweight/ obese pre-diabetic adolescents.

4) Compare the effect of the diet program only and the diet with a designed aerobic exercise program on the blood glucose level (FBG, HbA1C) and the quality of life of the participants.

BACKGROUND:

Obesity is defined as a common chronic disorder of excessive body fat. It has become a global epidemic that is present not only in the industrialized world but also in many developing and even underdeveloped countries (Hans, 2017).

Overweight children and adolescents often suffer from symptoms of depression and anxiety, poor self-esteem, and social stigma. These psychological aspects complicate global care and affect the quality of life (QOL). The overall QOL score was lower in the overweight and obese groups compared with the normal-weight groups in all the clinical population studies. The published results also indicate that impairment in QOL worsens with a degree of obesity (Marie et al., 2014).

HYPOTHESES:

There will be no significant difference effect between the diet program only and diet program with a designed aerobic exercise program on blood glucose levels and QOL in overweight/ obese prediabetic adolescents.

RESEARCH QUESTION:

Does the designed aerobic exercise influence the blood glucose level and the quality of life in pre-diabetic overweight/obese adolescents?

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusive criteria:

The participants will be selected according to the following criteria:

  • Their ages range from 12 to 18 years old.
  • They will be overweight and obese according to BMI charts of CDC:
  • Overweight is 85 percentiles to less than the 95 percentile,
  • Obesity is 95 percentile or greater) (CDC, 2022).
  • They will be prediabetic according to CDC, USPSTF (2022):
  • HbA1c level of will be 5.7% to 6.4%,
  • A fasting plasma glucose level will be 100 to 125 mg/dL.
  • Their waist circumference percentiles will be in the area outside of the normal WC curve according to WHO, normal children and adolescents are in the area under the curve (AUC): 0.69 for boys; 0.63 for girls for normal adolescents) (Bo xi et al., 2020)
  • They will be able to follow instructions during evaluation and treatment.

Exclusive criteria:

Any adolescent with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:

  • Cardiovascular diseases,
  • Diabetes Mellitus,
  • Morbid obesity more than 120% of the 95 percentile or greater or 35 kg/m or greater.
  • Hearing or visual impairments.
  • Any orthopedic deformities in upper limb or lower limb.
  • Uncontrolled seizures.
  • Receiving any special medications.
  • Participated regularly in sportive activities.

Treatment and study plan

Aerobic Exercise Program

Behavioral

aerobic exercise program for 3 months with nutritional health awearness sessions

nutritional health awareness sessions

Behavioral

lifestyle changes and nutritional awareness sessions for 3 months twice a week for participants and their parents

Primary outcomes

  1. changed HbA1c

    Time frame: 3 months

  2. changed BMI

    Time frame: 3 months

  3. changed Quality of life questionnaire results

    Time frame: 3 months

Secondary outcomes

  1. changed waist circumference

    Time frame: 3 months

  2. changed fasting blood glucose level

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

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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