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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04794244
Other study ID # Project number: 116S210
Secondary ID 116S210
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2017
Est. completion date July 9, 2019

Study information

Verified date March 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date July 9, 2019
Est. primary completion date December 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 12 Years
Eligibility 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 Design


Intervention

Behavioral:
ASGE-FABES Program
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.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
aysun ardiç

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. "through study completion, an average of 1 year".
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