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:

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
10-14 years old adolescent are given health education Health education was given
Other: Health Education: Healthy Choices Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bahçeşehir University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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