- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06442696
Effect Of HCP On Nutrition, Physical Activity And Body Mass Index
May 29, 2024 updated by: Tugba Duygu Ozmet, Bahçeşehir University
Effect Of Healthy Choices Program On Nutrition, Physical Activity And Body Mass Index In Adolescents
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:
- Effectiveness of Healthy Choices on Body Mass Index
- Effectiveness of Healthy Choices on Health Attitude, Nutrition and Physical Activity Knowledge
- Effectiveness of Healthy Choices on Fruit,vegetable, water consumption
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In our study, a quasi-experimental design with a pre-test and post-test control group was used.
This study was carried out between May 2022 and January 2023.
150 adolescents in the 5th, 6th and 7th grades of two secondary schools in Istanbul were included in the study.
One of the schools was designated as the intervention group (n=75) and the other as the control group (n=75).
Six sessions of training were given to the intervention group.
Data were collected using the Descriptive Characteristics Form, Healthy Habits Questionnaire, Adolescent Attitude Scale, Adolescent Physical Activity Knowledge Scale, Adolescent Nutrition Knowledge Scale and Physical Activity Questionnaire.
Chi-square test, t test, Mann-Whitney U test, Wilcoxon test were used to analyze the data.
Study Type
Interventional
Enrollment (Actual)
150
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
-
-
-
Istanbul, Turkey, 34100
- Tugba Duygu OZMET
-
-
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
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Male and female adolescents in 6th, 7th and 8th grades
- Adolescents without mental disabilities
- Families and adolescents who agree to participate in the study
Exclusion Criteria:
- Families and adolescents who did not agree to participate in the study were not included in the study.
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: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
10-14 years old adolescent are given health education Health education was given
|
Six session for students and school personel
|
|
No Intervention: Control Group
10-14 years old adolescent are not given health education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increasing consumption of fruit and vegetables in the experimental group
Time Frame: Up to six months
|
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
Time Frame: Up to six months
|
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
Time Frame: Up to six months
|
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
Time Frame: Up to six months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increasing consumption water and milk of adolescents in the experimental group
Time Frame: Up to six months
|
It was measured by using Healthy Habits Questionnaire (Item 9:How many 8-ounce servings of the following do you drink water/milk a day?)There is no scoring for this questionnaire.
|
Up to six months
|
|
Increasing healthy lifestyle attitude scale score of adolescents in the experimental group
Time Frame: Up to six months
|
It was measured using the healthy lifestyle attitude scale.
The scale was composed of 14 items to determine adolescents' attitudes toward nutrition, physical activity, and sleep behavior.
The responses are scored on a 5-point Likert-type scale ranging from strongly disagree (1) to agree (5) strongly.
The Cronbach's alpha of the original scale is 0.84 and the item-total score correlations are between 0.43 and 0.68 .
|
Up to six months
|
|
Increasing adolescent nutrition knowledge of adolescents in the experimental group
Time Frame: Up to six months
|
It was measured using the adolescent nutrition knowledge scale.
The scale consisted of 20 items and was developed to determine the level of knowledge about nutrition in adolescents, such as the types of nutrients, portion size, and eating habits.
The answer categories of each question are structured as "yes", "no" or "do not know".
The Cronbach's alpha of the original scale is 0.86, and item-total score correlations are between 0.13 and 0.59.
|
Up to six months
|
|
Increasing Adolescent activity knowledge of adolescents in the experimental group
Time Frame: Up to six months
|
It was measured using the adolescent activity knowledge scale.
The Activity Scale consists of 12 items and was developed to determine the knowledge level of physical activity and exercise in adolescents.
The answers categories of each question are structured as "yes", "no", and "do not know".
The Cronbach's alpha of the original scale is 0.69, and item-total score correlations are between 0.22 and 0.46.
|
Up to six months
|
|
Reducing Body Mass Index of adolescents in the experimental group
Time Frame: Up to six months
|
The weight and height of adolescents were measured by the researcher.
Tanita Bc-730 was used as a weighing machine.
Mesilife Mst-200 was used as a height meter.
They were measured in schools.
After, body mass indexes were calculated for each adolescent.
|
Up to six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tugba D Ozmet, PhD, Bahçeşehir University
- Study Chair: Tugba D Ozmet, PhD, Bahçeşehir University
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)
May 15, 2022
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
January 15, 2023
Study Registration Dates
First Submitted
February 7, 2024
First Submitted That Met QC Criteria
May 29, 2024
First Posted (Estimated)
June 4, 2024
Study Record Updates
Last Update Posted (Estimated)
June 4, 2024
Last Update Submitted That Met QC Criteria
May 29, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123 (Giresun University Scientific Research Project)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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