- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04794244
Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İ̇stanbul
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Istanbul, İ̇stanbul, Turkey, 3400
- Istanbul University-Cerrahpasa
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being overweight or obese
- 11-12 age range
- children asked by their parents to participate in the study
Exclusion Criteria:
- having a genetic disease
- normal weight
- mental disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental
group in which the experimental group training program is applied
|
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.
|
NO_INTERVENTION: No Intervention
group without control group training program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
"through study completion, an average of 1 year".
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: aysun ARDIÇ, Ph.D, Istanbul University - Cerrahpasa (IUC)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Project number: 116S210
- 116S210 (OTHER_GRANT: The Scientific and Technological Research Council of Turkey)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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