Healthy Lifestyle BehaviorsNCT04794244
Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats
A study testing ASGE-FABES Program in people with Healthy Lifestyle Behaviors and Overweight Adolescents, run by aysun ardıç at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to develop multiple behavioral strategies for the prevention of obesity in adolescents. ASGE-FABES [Adolescent Health Promotion Physical Activity, Physical activity of overweight and obese youth of Nutrition, Stress Management] Program,to evaluate its effects on nutrition and mental health. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle Behaviors, Overweight Adolescents, Obese Adolescents
- What is being tested?
- ASGE-FABES Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2017to 9 Jul 2019
- 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 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being overweight or obese
- 11-12 age range
- children asked by their parents to participate in the study
Who cannot join
- having a genetic disease
- normal weight
- mental disability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University-Cerrahpaşa
Istanbul, İ̇stanbul, 3400
About this study
Official title: Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats Effect:Randomized Controlled Study
The aim of this project is to develop multiple behavioral strategies for the prevention of obesity in adolescents.
ASGE-FABES [Adolescent Health Promotion Physical Activity, Physical activity of overweight and obese youth of Nutrition, Stress Management] Program,to evaluate its effects on nutrition and mental health. Program overweight and obeseadolescents to lose weight in a healthy way, healthy lifestyle behaviors make healthy choices, nutritional and physical activity knowledgecognitive and It aims to gain behavioral skills. In the study, "pretest-posttest in randomized groupswith control group, with repeated measures \& quot; experimental design type is used. The sample of the research,250 (125-experiment, 125-control) constituted an overweight and obese adolescent.
Read the detailed description
The aim of this project is to evaluate the impact of ASGE-FABES Program for the prevention of obesity in adolescents on physical activity, nutritional and mental health of overweight and obese adolescents. The program aims at promoting cognitive and behavioral skills for overweight and obese adolescents to lose weight in a healthy way, to promote healthy lifestyle behaviors, to make healthy choices, to increase their knowledge of nutrition and physical activity, to assume their own health responsibilities and to cope with stress. In the study, quot;experimental design type with randomized groups, pretest-posttest control group, repeated measurement\" was used. The sample of the study consisted of 250 overweight and obese adolescents studying in the 6th grade of 10 secondary schools in Şişli district of Istanbul. The data of the study were collected using with Socio-Demographic Characteristics Form,Adolescent Nutrition Information Scale,Adolescent Physical Activity Information Scale, Adolescent Lifestyle Scale, Adolescent Healthy Lifestyle Choose Scale, Beck Anxiety Scale, Daily Food Consumption Form and Beverage Consumption Form.The data were collected before the application, at the first week after the application, and at the sixth and 12th months. Descriptive statistical tests, pearson chi-square tests, t-test in similar groups, repeated measures anova, and Cohen\'s effect size tests were used in the analysis of the study. There was no significant difference between the experimental and control groups in terms of the descriptive characteristics, behavioral and cognitive variables of adolescents.
- Being tested
- ASGE-FABES Program
- Keywords
- Adolescent health, nursing, obesity, school health, healthy lifestyle behaviors
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASGE-FABES ProgramBehavioural
In the control group study, pretest-posttest and experimental design with repeated measurements were used in randomized groups. An overweight and obese adolescent constituted the sample of 250 (125-experiment, 125-control) of the study. Research data Socio-Demographic Features Information Form, Adolescent Nutrition Information Scale, Adolescent Physical Activity Information Scale, Adolescent Lifestyle Scale, Healthy Lifestyle Choice Scale for Adolescents, Beck Anxiety Scale, Daily Food Consumption Form, Beverage Consumption Form, collected using. Data are saved before and after application. ASGEFABES PROGRAM was applied to the experimental group for 10 weeks. Measurements after the training program were collected in four measurements: 1st week, 6th and 12th months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | group in which the experimental group training program is applied Receives: Behavioral: ASGE-FABES Program |
| No Intervention | No intervention | group without control group training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
body measurements
The results of this study are the results of the ASGE-FABES program. In this study, body measurements include calculating body mass index. BKI is calculated as kg / m ^ 2.
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start20 Sep 2017
- Primary completion20 Dec 2017
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Lifestyle BehaviorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- aysun ardıç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, aysun ardıç, Istanbul University - Cerrahpasa
- Investigators
- aysun ARDIÇ, Ph.D, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794244
- Sponsor's protocol ID
- Project number: 116S210
- Other IDs
- 116S210
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I reserve the data sharing as it is promised to the subjects that the data sharing will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats Effect:Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04794244
- Acronym / sponsor ID
- Project number: 116S210
- Keywords
- Adolescent health, nursing, obesity, school health, healthy lifestyle behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- aysun ardıçUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 12 Mar 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.
The aim of this project is to develop multiple behavioral strategies for the prevention of obesity in adolescents.
ASGE-FABES [Adolescent Health Promotion Physical Activity, Physical activity of overweight and obese youth of Nutrition, Stress Management] Program,to evaluate its effects on nutrition and mental health. Program overweight and obeseadolescents to lose weight in a healthy way, healthy lifestyle behaviors make healthy choices, nutritional and physical activity knowledgecognitive and It aims to gain behavioral skills. In the study, "pretest-posttest in randomized groupswith control group, with repeated measures \& quot; experimental design type is used. The sample of the research,250 (125-experiment, 125-control) constituted an overweight and obese adolescent.
Detailed description
The aim of this project is to evaluate the impact of ASGE-FABES Program for the prevention of obesity in adolescents on physical activity, nutritional and mental health of overweight and obese adolescents. The program aims at promoting cognitive and behavioral skills for overweight and obese adolescents to lose weight in a healthy way, to promote healthy lifestyle behaviors, to make healthy choices, to increase their knowledge of nutrition and physical activity, to assume their own health responsibilities and to cope with stress. In the study, quot;experimental design type with randomized groups, pretest-posttest control group, repeated measurement\" was used. The sample of the study consisted of 250 overweight and obese adolescents studying in the 6th grade of 10 secondary schools in Şişli district of Istanbul. The data of the study were collected using with Socio-Demographic Characteristics Form,Adolescent Nutrition Information Scale,Adolescent Physical Activity Information Scale, Adolescent Lifestyle Scale, Adolescent Healthy Lifestyle Choose Scale, Beck Anxiety Scale, Daily Food Consumption Form and Beverage Consumption Form.The data were collected before the application, at the first week after the application, and at the sixth and 12th months. Descriptive statistical tests, pearson chi-square tests, t-test in similar groups, repeated measures anova, and Cohen\'s effect size tests were used in the analysis of the study. There was no significant difference between the experimental and control groups in terms of the descriptive characteristics, behavioral and cognitive variables of adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: ASGE-FABES Programgroup in which the experimental group training program is applied |
| No Intervention | No intervention | –group without control group training program |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being overweight or obese
- 11-12 age range
- children asked by their parents to participate in the study
Key exclusion criteria (3 listed)
- having a genetic disease
- normal weight
- mental disability
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 |
|---|---|---|
| ASGE-FABES ProgramIn the control group study, pretest-posttest and experimental design with repeated measurements were used in randomized groups. An overweight and obese adolescent constituted the sample of 250 (125-experiment, 125-control) of the study. Research data Socio-Demographic Features Information Form, Adolescent Nutrition Information Scale, Adolescent Physical Activity Information Scale, Adolescent Lifestyle Scale, Healthy Lifestyle Choice Scale for Adolescents, Beck Anxiety Scale, Daily Food Consumption Form, Beverage Consumption Form, collected using. Data are saved before and after application. ASGEFABES PROGRAM was applied to the experimental group for 10 weeks. Measurements after the training program were collected in four measurements: 1st week, 6th and 12th months. | Behavioural | Experimental |
Primary outcome
body measurements
Time frame: "through study completion, an average of 1 year".
The results of this study are the results of the ASGE-FABES program. In this study, body measurements include calculating body mass index. BKI is calculated as kg / m ^ 2.
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 12 Mar 2021.
- Individual participant dataSharing planned: No. I reserve the data sharing as it is promised to the subjects that the data sharing will be kept confidential.
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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.
aysun ARDIÇ, Ph.D principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASGE-FABES Program in people with Healthy Lifestyle Behaviors and Overweight Adolescents, run by aysun ardıç at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 12 Mar 2021. 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 Turkey (Türkiye). 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?
body measurements (time frame: "through study completion, an average of 1 year".). 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 12 Mar 2021.