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?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: study group, overweight and obese adolescents with prediabetes
|
aerobic exercise program for 3 months with nutritional health awearness sessions
lifestyle changes and nutritional awareness sessions for 3 months twice a week for participants and their parents
|
|
Active Comparator: control group, overweight and obese adolescents with prediabetes
|
lifestyle changes and nutritional awareness sessions for 3 months twice a week for participants and their parents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
changed HbA1c
Time Frame: 3 months
|
3 months
|
|
changed BMI
Time Frame: 3 months
|
3 months
|
|
changed Quality of life questionnaire results
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
changed waist circumference
Time Frame: 3 months
|
3 months
|
|
changed fasting blood glucose level
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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