NCT04794244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 2, 2021

Last Update Submit

March 9, 2021

Conditions

Keywords

Adolescent healthnursingobesityschool healthhealthy lifestyle behaviors

Outcome Measures

Primary Outcomes (1)

  • 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".

Study Arms (2)

Experimental

EXPERIMENTAL

group in which the experimental group training program is applied

Behavioral: ASGE-FABES Program

No Intervention

NO INTERVENTION

group without control group training program

Interventions

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.

Experimental

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being overweight or obese
  • age range
  • children asked by their parents to participate in the study

You may not qualify if:

  • having a genetic disease
  • normal weight
  • mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrahpaşa

Istanbul, İ̇stanbul, 3400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • aysun ARDIÇ, Ph.D

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D. lecturer, lead researcher

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 12, 2021

Study Start

September 20, 2017

Primary Completion

December 20, 2017

Study Completion

July 9, 2019

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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

Locations