ObesityNCT06442696
Effect Of HCP On Nutrition, Physical Activity And Body Mass Index
A study testing Health Education: Healthy Choices Program in people with Obesity and Adolescent Obesity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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. Effectiveness of Healthy Choices on Body Mass Index 2. Effectiveness of Healthy Choices on Health Attitude, Nutrition and Physical Activity Knowledge 3. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent Obesity
- What is being tested?
- Health Education: Healthy Choices Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female adolescents in 6th, 7th and 8th grades
- Adolescents without mental disabilities
- Families and adolescents who agree to participate in the study
Who cannot join
- Families and adolescents who did not agree to participate in the study were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity, Adolescent Obesity
- Being tested
- Health Education: Healthy Choices Program
- Keywords
- School nursing, Healthy choices, Nutrition, Physical Activity
- Medical subject headings
- Obesity, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education: Healthy Choices ProgramOther
Six session for students and school personel
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 10-14 years old adolescent are given health education Health education was given Receives: Other: Health Education: Healthy Choices Program |
| Control Group | No intervention | 10-14 years old adolescent are not given health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.)
Measured: 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.
Measured: 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)
Measured: Up to six months
Secondary outcomes (5)
Increasing consumption water and milk of adolescents in the experimental group
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.
Measured: Up to six months
Increasing healthy lifestyle attitude scale score of adolescents in the experimental group
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 .
Measured: Up to six months
Increasing adolescent nutrition knowledge of adolescents in the experimental group
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.
Measured: Up to six months
Increasing Adolescent activity knowledge of adolescents in the experimental group
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.
Measured: Up to six months
Reducing Body Mass Index of adolescents in the experimental group
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.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 May 2022
- Primary completion15 Jun 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Duygu Ozmet, Bahçeşehir University
- Investigators
- Tugba D Ozmet, PhD, Principal investigator, Bahçeşehir UniversityTugba D Ozmet, PhD, Study chair, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442696
- Sponsor's protocol ID
- 123
- Status last verified
- May 2024
- First submitted
- 7 Feb 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Healthy Choices Program On Nutrition, Physical Activity And Body Mass Index In Adolescents
- ClinicalTrials.gov ID
- NCT06442696
- Acronym / sponsor ID
- 123
- Conditions
- Obesity, Adolescent Obesity
- Keywords
- School nursing, Healthy choices, Nutrition, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Health Education: Healthy Choices Program10-14 years old adolescent are given health education Health education was given |
| Control Group | No intervention | –10-14 years old adolescent are not given health education |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female adolescents in 6th, 7th and 8th grades
Key exclusion criteria (1 listed)
- Families and adolescents who did not agree to participate in the study were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Education: Healthy Choices ProgramSix session for students and school personel | Other | Intervention Group |
Primary outcome
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.
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.)
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.
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)
5 secondary outcomes
Increasing consumption water and milk of adolescents in the experimental group
Time frame: Up to six months
Increasing healthy lifestyle attitude scale score of adolescents in the experimental group
Time frame: Up to six months
Increasing adolescent nutrition knowledge of adolescents in the experimental group
Time frame: Up to six months
Increasing Adolescent activity knowledge of adolescents in the experimental group
Time frame: Up to six months
Reducing Body Mass Index of adolescents in the experimental group
Time frame: Up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tugba D Ozmet, PhD principal investigator
Bahçeşehir University
Tugba D Ozmet, PhD study chair
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education: Healthy Choices Program in people with Obesity and Adolescent Obesity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increasing consumption of fruit and vegetables in the experimental group (time frame: Up to six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.