Anorexia in AdolescenceNCT05057000
Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia
A study testing aerobic exercises + Diet and diet proram in people with Anorexia in Adolescence, run by Badr University at 1 site in Egypt.
Trial summary
Randomized control study used to identify the effect of aerobic exercises on the activity of daily living and estradiol serum level in young girls with anorexia Read more about this study
- Who is it for?
- Ages 14 to 17 years, women only
- Conditions the study is for
- Anorexia in Adolescence
- What is being tested?
- aerobic exercises + Diet and diet proram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2021to 30 Dec 2021
- 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 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Thirty girls with anorexia
- BMI ≤ 18 kg/m2
- Age ranged from (14-17 years).
Who cannot join
- Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Badr University
Cairo
Mariam El Ebrashy, Phd, 01001716570, Mariam.elabrashi@buc.edu.eg
About this study
Official title: Effect of Aerobic Exercises and Nutrition on The Activities of Daily Living and Estrogen Level in Adolescent Girls With Anorexia
Randomized control study used to identify the effect of aerobic exercises on the activity of daily living and estradiol serum level in young girls with anorexia
Read the detailed description
Control group will receive diet program while the study group received the same diet program given to control group in addition to AEROBIC exercise program.
Inclusive criteria
- Thirty girls with anorexia
- BMI ≤ 18 kg/m2
- Age ranged from (14-17 years).
- Exclusive criteria:
- Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.
- Exclude any other eating disorders
Data analysis and statistical design:
The collected data will be statistically treated using:
Descriptive statistics.
Inferential statistics using:
Paired t-test.
- Conditions
- Anorexia in Adolescence
- Being tested
- aerobic exercises + Diet, diet proram
- Keywords
- anorexia, adolescent girls, areobic exercises
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercises + DietOther
Frequency 5-6 days per week Intensity To perform moderate intensity for weight-bearing aerobic exercise Time Goal of 20-30 min per session of moderate-intensity aerobic activity per week
diet proramOther
diet program for anorexic adolescent girls
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | DIET PROGRAM IN ADDITION TO AEROBIC EXRCISES Receives: Other: aerobic exercises + Diet |
| Group B | Other | DIET PROGRAM Receives: Other: diet proram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estradiol level
blood test
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 posted27 Sep 2021
- Study start5 Oct 2021
- Primary completion1 Dec 2021
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia in AdolescenceStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Hossam El Ebrashy, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057000
- Sponsor's protocol ID
- BUC
- Status last verified
- Jan 2022
- First submitted
- 13 Sep 2021
- Last updated
- 4 Jan 2022
- 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 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercises and Nutrition on The Activities of Daily Living and Estrogen Level in Adolescent Girls With Anorexia
- ClinicalTrials.gov ID
- NCT05057000
- Acronym / sponsor ID
- BUC
- Conditions
- Anorexia in Adolescence
- Keywords
- anorexia, adolescent girls, areobic exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Sep 2021 (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.
Randomized control study used to identify the effect of aerobic exercises on the activity of daily living and estradiol serum level in young girls with anorexia
Detailed description
Control group will receive diet program while the study group received the same diet program given to control group in addition to AEROBIC exercise program.
Inclusive criteria
- Thirty girls with anorexia
- BMI ≤ 18 kg/m2
- Age ranged from (14-17 years).
- Exclusive criteria:
- Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.
- Exclude any other eating disorders
Data analysis and statistical design:
The collected data will be statistically treated using:
Descriptive statistics.
Inferential statistics using:
Paired t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: aerobic exercises + DietDIET PROGRAM IN ADDITION TO AEROBIC EXRCISES |
| Group B | Other | Other: diet proramDIET PROGRAM |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Thirty girls with anorexia
- BMI ≤ 18 kg/m2
- Age ranged from (14-17 years).
Key exclusion criteria (1 listed)
- Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.
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 exercises + DietFrequency 5-6 days per week Intensity To perform moderate intensity for weight-bearing aerobic exercise Time Goal of 20-30 min per session of moderate-intensity aerobic activity per week | Other | Group A |
| diet proramdiet program for anorexic adolescent girls | Other | Group B |
Primary outcome
Estradiol level
Time frame: 3 months
blood test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- 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.
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 exercises + Diet and diet proram in people with Anorexia in Adolescence, run by Badr 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam EL Ebrashy, Phd (01001716570, Mariam.elabrashi@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estradiol level (time frame: 3 months). 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 4 Jan 2022.