Health BehaviorHASCV-RNCT06177145
"HASCV-R" Health Programme
A study testing HASCV-R program in people with Health Behavior, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled trial: is to determine the effect of " HASCV-R " health programme on the health promoting and protective behaviours of the Turkish-Greek Population Exchange migrant women. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- HASCV-R program
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Nov 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteering to participate in the study,
- be between the ages of 18 and 49,
- being a immigrant women,
- no communication barriers (to communicate with any problem such as hearing problem, speech impediment),
- to be married
Who cannot join
- being younger than 18 or over 49,
- be man,
- ınability to communicate with any problem such as hearing problem, speech impediment,
- living single,
- refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect "HASCV-R" Health Programme on Health Promoting and Protective Behaviours of the Turkish-Greek Population Exchange Migrant Women: a Randomized Controlled Trial
The goal of this randomized controlled trial: is to determine the effect of " HASCV-R " health programme on the health promoting and protective behaviours of the Turkish-Greek Population Exchange migrant women. The main question it aims to answer are:
- Does the HASCV-R program, positively affect the health promoting and protective behaviours of Turkish-Greek Population Exchange migrant women? The health program was given to the migrant women in the experimental group in five sessions of 40 minutes each for five weeks. The program was implemented to 48 migrant women. After obtaining consent from immigrant men, Data were gathered with all participants at the available time and places. The data were collected from the control and experimental groups at two different times, prior to the program was implemented and 3 months after the program was implemented.
Read the detailed description
Health protection is the regulation of the environment in which the person lives both physically and socially. Health promotion, on the other hand, is defined as achieving optimal health, improving health by focusing on some cognitive factors and achieving optimal physical and mental health. The good quality of life of individuals is directly related to having health-protective and health-promoting behaviours. In the literature, there are training programmes to improve women's health, but there are no health-promoting and health-protective training programmes.
With the Lausanne Peace Treaty signed between Greece and Turkey in 1923, most of the Turks in Greece and Greeks in Turkey were subjected to forced migration. Thousands of Turks who were sent to Turkey after this agreement were settled in different parts of the country. Akdağmadeni district of Yozgat province is among these regions. These people and subsequent generations who experienced forced migration are called " Turkish-Greek Population Exchange ". The lifestyle, eating habits and cultures of the immigrants differ from the local people. In the literature, there is no health programme that improves or protects the health of immigrants. The unique value of this study is that it will be carried out with women who are immigrants and that the programme includes health-promoting and protective behaviours.
This research was conducted in accordance with the principles of double-blind randomised controlled pretest-posttest experimental research. In this research, the immigrant women do not know whether they are in the experimental or control group. The statistician conducting the research does not know which data belong to which group. In this way, blinding was done.
This study was carried out with the immigrant women living in Akdağmadeni district of Yozgat province. Trainings and measurement tools in the HASCV-R programme was implemented in the training centres in the neighbourhoods where immigrant women lived with the support of Akdağmadeni Lausanne Immigrants Association. The research was conducted between 15 May 2023 and 15 November 2023.
The population of the research consists of married women registered to Akdağmadeni Lausanne Mübadilleri Association residing in Akdağmadeni district centre where the research was conducted. The research was carried out with 2 different groups, 1 experimental group and 1 control group. According to the power analysis performed with G Power Clinic Calc programme, 45 experimental and 45 control groups were determined for 90% power and 0.05 type error. Considering the possibility of losses, the experimental group was increased by 10%. The study was planned to be carried out with 50 experimental and 50 control groups, with 5 substitutes for each group, totalling 100 married women who were immigrants. The study was conducted with 94 women, 48 experimental and 46 control groups.
Inclusion Criteria
- volunteering to participate in the study,
- be between the ages of 18 and 49,
- being a immigrant women,
- no communication barriers (to communicate with any problem such as hearing problem, speech impediment),
- to be married Exclusion Criteria
- being younger than 18 or over 49,
- be man,
- ınability to communicate with any problem such as hearing problem, speech impediment,
- living single,
- refusing to participate in the study
- Conditions
- Health Behavior
- Being tested
- HASCV-R program
- Keywords
- Health behaviors, health promotion, Exchange migrant women
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HASCV-R programOther
"Healthy nutrition, Active life, Ways to cope with Stress, Cancer and cancer screening, Vaccination - Reproductive health" Training programme
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | This study was carried out with the immigrant women living in Akdağmadeni district of Yozgat province. Trainings and measurement tools in the HASCV-R programme was implemented in the training centres in the neighbourhoods where immigrant women lived with the support of Akdağmadeni Lausanne Immigrants Association. Receives: Other: HASCV-R program |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire form
This form, developed by the researchers based on the literature, includes the socio-demographic characteristics of the men such as age, education status, income status, etc.).
Measured: Prior to the program was implemented
Secondary outcomes (2)
Health Promoting and Protective Behaviours Scale
Evaluates the extent to which the individual keeps himself active in daily life, regular exercise behaviours and behaviours related to meeting physiological needs such as eating and drinking. Max:120, min;24
Measured: prior to the program was implemented and 3 months after the program was implemented
Scale for Determining Reproductive Health Protective Attitudes of Married Women
It was developed to determine the reproductive health protective attitudes and behaviours of married women. Max; 50, min;10
Measured: prior to the program was implemented and 3 months after the program was implemented
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start15 May 2023
- Primary completion15 Sep 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- double-blind randomised controlled pretest-posttest experimental research
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet KORKMAZ, Bozok University
- Investigators
- Derya Ozturk, pHD, Principal investigator, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177145
- Sponsor's protocol ID
- 01/20
- Acronym
- HASCV-R
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 29 May 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect "HASCV-R" Health Programme on Health Promoting and Protective Behaviours of the Turkish-Greek Population Exchange Migrant Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06177145
- Acronym / sponsor ID
- HASCV-R / 01/20
- Conditions
- Health Behavior
- Keywords
- Health behaviors, health promotion, Exchange migrant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 20 Dec 2023 (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 randomized controlled trial: is to determine the effect of " HASCV-R " health programme on the health promoting and protective behaviours of the Turkish-Greek Population Exchange migrant women. The main question it aims to answer are:
- Does the HASCV-R program, positively affect the health promoting and protective behaviours of Turkish-Greek Population Exchange migrant women? The health program was given to the migrant women in the experimental group in five sessions of 40 minutes each for five weeks. The program was implemented to 48 migrant women. After obtaining consent from immigrant men, Data were gathered with all participants at the available time and places. The data were collected from the control and experimental groups at two different times, prior to the program was implemented and 3 months after the program was implemented.
Detailed description
Health protection is the regulation of the environment in which the person lives both physically and socially. Health promotion, on the other hand, is defined as achieving optimal health, improving health by focusing on some cognitive factors and achieving optimal physical and mental health. The good quality of life of individuals is directly related to having health-protective and health-promoting behaviours. In the literature, there are training programmes to improve women's health, but there are no health-promoting and health-protective training programmes.
With the Lausanne Peace Treaty signed between Greece and Turkey in 1923, most of the Turks in Greece and Greeks in Turkey were subjected to forced migration. Thousands of Turks who were sent to Turkey after this agreement were settled in different parts of the country. Akdağmadeni district of Yozgat province is among these regions. These people and subsequent generations who experienced forced migration are called " Turkish-Greek Population Exchange ". The lifestyle, eating habits and cultures of the immigrants differ from the local people. In the literature, there is no health programme that improves or protects the health of immigrants. The unique value of this study is that it will be carried out with women who are immigrants and that the programme includes health-promoting and protective behaviours.
This research was conducted in accordance with the principles of double-blind randomised controlled pretest-posttest experimental research. In this research, the immigrant women do not know whether they are in the experimental or control group. The statistician conducting the research does not know which data belong to which group. In this way, blinding was done.
This study was carried out with the immigrant women living in Akdağmadeni district of Yozgat province. Trainings and measurement tools in the HASCV-R programme was implemented in the training centres in the neighbourhoods where immigrant women lived with the support of Akdağmadeni Lausanne Immigrants Association. The research was conducted between 15 May 2023 and 15 November 2023.
The population of the research consists of married women registered to Akdağmadeni Lausanne Mübadilleri Association residing in Akdağmadeni district centre where the research was conducted. The research was carried out with 2 different groups, 1 experimental group and 1 control group. According to the power analysis performed with G Power Clinic Calc programme, 45 experimental and 45 control groups were determined for 90% power and 0.05 type error. Considering the possibility of losses, the experimental group was increased by 10%. The study was planned to be carried out with 50 experimental and 50 control groups, with 5 substitutes for each group, totalling 100 married women who were immigrants. The study was conducted with 94 women, 48 experimental and 46 control groups.
Inclusion Criteria
- volunteering to participate in the study,
- be between the ages of 18 and 49,
- being a immigrant women,
- no communication barriers (to communicate with any problem such as hearing problem, speech impediment),
- to be married Exclusion Criteria
- being younger than 18 or over 49,
- be man,
- ınability to communicate with any problem such as hearing problem, speech impediment,
- living single,
- refusing to participate in the study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- double-blind randomised controlled pretest-posttest experimental research
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: HASCV-R programThis study was carried out with the immigrant women living in Akdağmadeni district of Yozgat province. Trainings and measurement tools in the HASCV-R programme was implemented in the training centres in the neighbourhoods where immigrant women lived with the support of Akdağmadeni Lausanne Immigrants Association. |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- volunteering to participate in the study,
- be between the ages of 18 and 49,
- being a immigrant women,
- no communication barriers (to communicate with any problem such as hearing problem, speech impediment),
- to be married
Key exclusion criteria (5 listed)
- being younger than 18 or over 49,
- be man,
- ınability to communicate with any problem such as hearing problem, speech impediment,
- living single,
- refusing to participate 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 |
|---|---|---|
| HASCV-R program"Healthy nutrition, Active life, Ways to cope with Stress, Cancer and cancer screening, Vaccination - Reproductive health" Training programme | Other | experimental |
Primary outcome
Questionnaire form
Time frame: Prior to the program was implemented
This form, developed by the researchers based on the literature, includes the socio-demographic characteristics of the men such as age, education status, income status, etc.).
2 secondary outcomes
Health Promoting and Protective Behaviours Scale
Time frame: prior to the program was implemented and 3 months after the program was implemented
Scale for Determining Reproductive Health Protective Attitudes of Married Women
Time frame: prior to the program was implemented and 3 months after the program was implemented
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 29 May 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.
Derya Ozturk, pHD principal investigator
Bozok 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 HASCV-R program in people with Health Behavior, run by Bozok 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 5 inclusion and 5 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 29 May 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?
Questionnaire form (time frame: Prior to the program was implemented). 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 29 May 2024.