Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats
Primary Purpose
Healthy Lifestyle Behaviors, Overweight Adolescents, Obese Adolescents
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ASGE-FABES Program
Sponsored by

About this trial
This is an interventional prevention trial for Healthy Lifestyle Behaviors focused on measuring Adolescent health, nursing, obesity, school health, healthy lifestyle behaviors
Eligibility Criteria
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
Sites / Locations
- İstanbul University-Cerrahpaşa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
No Intervention
Arm Description
group in which the experimental group training program is applied
group without control group training program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04794244
Brief Title
Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats
Official Title
Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats Effect:Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
July 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
aysun ardıç
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Lifestyle Behaviors, Overweight Adolescents, Obese Adolescents
Keywords
Adolescent health, nursing, obesity, school health, healthy lifestyle behaviors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
group in which the experimental group training program is applied
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
group without control group training program
Intervention Type
Behavioral
Intervention Name(s)
ASGE-FABES Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
body measurements
Description
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.
Time Frame
"through study completion, an average of 1 year".
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
aysun ARDIÇ, Ph.D
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
İstanbul University-Cerrahpaşa
City
Istanbul
State/Province
İ̇stanbul
ZIP/Postal Code
3400
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I reserve the data sharing as it is promised to the subjects that the data sharing will be kept confidential.
Learn more about this trial
Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats
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