NCT06442696

Brief Summary

The goal of this clinical trial is to test effectiveness of "The Healthy Choices Program, in adolescents. The main question\[s\] it aims to answer are:

  1. 1.Effectiveness of Healthy Choices on Body Mass Index
  2. 2.Effectiveness of Healthy Choices on Health Attitude, Nutrition and Physical Activity Knowledge
  3. 3.Effectiveness of Healthy Choices on Fruit,vegetable, water consumption

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

February 7, 2024

Last Update Submit

May 29, 2024

Conditions

Keywords

School nursingHealthy choicesNutritionPhysical Activity

Outcome Measures

Primary Outcomes (4)

  • Increasing consumption of fruit and vegetables in the experimental group

    It was measured by using Healthy Habits Questionnaire. (Item 1:How many servings of ruits or vegetables do you eat a day? (One serving is most easily identified by the size of the palm of your hand.) There is no scoring for this questionnaire.

    Up to six months

  • Decreasing screen time of adolescents in the experimental group

    It was measured by using the Healthy Habits Questionnaire. (Item 5:How many hours a day do you watch TV/movies or sit and play video/computer games? There is no scoring for this questionnaire.)

    Up to six months

  • Increasing physical activity level of adolescents in the experimental group

    It was measured using the Healthy Habits and Physical Activity Questionnaire. In Healthy Habits Questionnaire Item 8:How much time a day do you spend in active play (faster breathing/heart rate or sweating)? was used. The Physical Activity Questionnaire is a 7-day recall-based measurement tool designed to assess overall physical activity levels throughout the school year.The minimum score for each item of the questionnaire is 1 and the maximum score is 5. The minimum score to be obtained from questionnaire is 9 and the maximum score is 45. Item 10 is not included in scoring.

    Up to six months

  • Decreasing consumption sugary drinks of adolescents in the experimental group

    It was measured by Healthy Habits Questionnaire (Item 9:How How many 8-ounce servings of the following do you drink a day (soda,fruit juice,sport drinks)

    Up to six months

Secondary Outcomes (5)

  • Increasing consumption water and milk of adolescents in the experimental group

    Up to six months

  • Increasing healthy lifestyle attitude scale score of adolescents in the experimental group

    Up to six months

  • Increasing adolescent nutrition knowledge of adolescents in the experimental group

    Up to six months

  • Increasing Adolescent activity knowledge of adolescents in the experimental group

    Up to six months

  • Reducing Body Mass Index of adolescents in the experimental group

    Up to six months

Study Arms (2)

Intervention Group

EXPERIMENTAL

10-14 years old adolescent are given health education Health education was given

Other: Health Education: Healthy Choices Program

Control Group

NO INTERVENTION

10-14 years old adolescent are not given health education

Interventions

Six session for students and school personel

Intervention Group

Eligibility Criteria

Age10 Years - 14 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male and female adolescents in 6th, 7th and 8th grades
  • Adolescents without mental disabilities
  • Families and adolescents who agree to participate in the study

You may not qualify if:

  • Families and adolescents who did not agree to participate in the study were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tugba Duygu OZMET

Istanbul, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityPediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tugba D Ozmet, PhD

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR
  • Tugba D Ozmet, PhD

    Bahçeşehir University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

February 7, 2024

First Posted

June 4, 2024

Study Start

May 15, 2022

Primary Completion

June 15, 2022

Study Completion

January 15, 2023

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations