ObesityNCT06756425
Effect of Aerobic Exercise Program on Blood Glucose Level and Quality of Life in Pre-diabetic Overweight/Obese Adolescents
A study testing aerobic exercise program and nutritional health awareness sessions in people with Obesity and Prediabetes, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Obesity, Prediabetes
- What is being tested?
- aerobic exercise program and nutritional health awareness sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2022to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate
About this study
PURPOSE:
The study aims to:
Read more
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.
- 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.
- Investigate the effect of the designed aerobic exercise program on the quality of life in overweight/ obese pre-diabetic adolescents.
- 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?
- Conditions
- Obesity, Prediabetes
- Being tested
- aerobic exercise program, nutritional health awareness sessions
- Keywords
- obesity, prediabetes, aerobic exercises, quality of life, blood glucose level, HbA1C, adolescents
- Medical subject headings
- Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise programBehavioural
aerobic exercise program for 3 months with nutritional health awearness sessions
nutritional health awareness sessionsBehavioural
lifestyle changes and nutritional awareness sessions for 3 months twice a week for participants and their parents
| Study group | Role | What they receive |
|---|---|---|
| study group, overweight and obese adolescents with prediabetes | Active comparator | Not described Receives: Behavioral: aerobic exercise program; Behavioral: nutritional health awareness sessions |
| control group, overweight and obese adolescents with prediabetes | Active comparator | Not described Receives: Behavioral: nutritional health awareness sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
changed HbA1c
Measured: 3 months
changed BMI
Measured: 3 months
changed Quality of life questionnaire results
Measured: 3 months
Secondary outcomes (2)
changed waist circumference
Measured: 3 months
changed fasting blood glucose level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start10 Sep 2022
- Primary completion4 Feb 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Nabil Samaan Meseha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756425
- Sponsor's protocol ID
- P.T.REC/012/005129
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Program on Blood Glucose Level and Quality of Life in Pre-diabetic Overweight/Obese Adolescents
- ClinicalTrials.gov ID
- NCT06756425
- Acronym / sponsor ID
- P.T.REC/012/005129
- Conditions
- Obesity, Prediabetes
- Keywords
- obesity, prediabetes, aerobic exercises, quality of life, blood glucose level, HbA1C, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 4 Feb 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Investigate the effect of the designed aerobic exercise program on the quality of life in overweight/ obese pre-diabetic adolescents.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group, overweight and obese adolescents with prediabetes | Active comparator | Behavioral: aerobic exercise program, Behavioral: nutritional health awareness sessions |
| control group, overweight and obese adolescents with prediabetes | Active comparator | Behavioral: nutritional health awareness sessions |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise programaerobic exercise program for 3 months with nutritional health awearness sessions | Behavioural | study group, overweight and obese adolescents with prediabetes |
| nutritional health awareness sessionslifestyle changes and nutritional awareness sessions for 3 months twice a week for participants and their parents | Behavioural | control group, overweight and obese adolescents with prediabetes, study group, overweight and obese adolescents with prediabetes |
Primary outcome
changed HbA1c
Time frame: 3 months
changed BMI
Time frame: 3 months
changed Quality of life questionnaire results
Time frame: 3 months
2 secondary outcomes
changed waist circumference
Time frame: 3 months
changed fasting blood glucose level
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise program and nutritional health awareness sessions in people with Obesity and Prediabetes, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changed HbA1c (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.