Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats

March 9, 2021 updated by: aysun ardıç

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

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 3400
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: aysun ARDIÇ, Ph.D, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2017

Primary Completion (ACTUAL)

December 20, 2017

Study Completion (ACTUAL)

July 9, 2019

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (ACTUAL)

March 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

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)?

NO

IPD Plan Description

I reserve the data sharing as it is promised to the subjects that the data sharing will be kept confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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