MenopauseNCT06802458
Motivational Interviewing on Healthy Lifestyle Behaviors and Quality of Life in on Menopausal Women
A study testing Motivational interviewing in people with Menopause and Nursing, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Background: This study aims to determine the effect of motivational interviewing on healthy lifestyle behaviors and quality of life in menopausal women. Methods: This is a randomized controlled empirical study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- Motivational interviewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2018to 15 Jun 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- being literate;
- being able to make a conscious decision to participate in the study, being able to communicate verbally, and being able to sign a consent form;
- having had menopause naturally and within the last 3 years;
- being sexually active;
- having no hormone replacement therapy.
Who cannot join
- unwilling to continue the study;
- having a psychiatric diagnosis according to the FHC records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motivational Interviewing on Healthy Lifestyle Behaviors and Quality of Life in on Menopausal Women: a Pilot Randomized Controlled Trial
Background: This study aims to determine the effect of motivational interviewing on healthy lifestyle behaviors and quality of life in menopausal women.
Methods: This is a randomized controlled empirical study. The study was conducted with a total of 136 women, including 68 for experimental group and 68 for control group. The data were collected using an introductory information form, the Health Promoting Lifestyle Profile II (HPLPL II) and the Menopause-Specific Quality of Life (MENQOL). Women in the experimental group received 6 sessions of motivational interviewing and 2 follow-up interviews in two family health centers (FHCs) from the researcher. No intervention was applied to women in the control group. The data were analyzed using number, percentage, mean, standard deviation, chi-square test, Bonferroni test, independent samples t test and repeated ANOVA.
- Being tested
- Motivational interviewing
- Keywords
- motivational interviewing, healthy lifestyle behavior, menopause specific quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingOther
A total of 9 sessions were conducted, including 1 preparation session, 6 motivational interviews, 1 initial follow-up interview one week after the intervention, and 2 follow-up interviews 4 weeks after the initial follow-up. Considering the interactive training method, the motivational interviewing sessions were conducted in the training room of the Health Center in groups of 10 at three different days (Monday, Thursday, Friday) once a week, through face-to-face sessions each lasting 50-60 minutes. During the interviews, the women were provided with counseling to activate their own sources of motivation, develop healthy lifestyle behaviors and improve their quality of life specific to menopause
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Experimental | Experimental | Not described Receives: Other: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Promoting Lifestyle Profile II
The scale includes six dimensions, namely, nutrition, physical activity, stress management, interpersonal relationships, responsibility for health, and spiritual growth (52 items in total). The items are scored based on a 4 point Likert scale (never, sometimes, often, and usually). The total score of the scale ranges from 52 to 208. The score of each dimension is calculated separately and a higher scores mean better health.
Measured: change from starting to 0. and 7. week
Menopause-Specific Quality of Life
This is a 7-point Likert-type scale containing 29 items and consists of four domains: vasomotor, psychosocial, physical and sexual. Each item is scored from "0" to "6", where "0" refers to "not bothersome" and "6" to "extremely bothersome". A higher scale score indicates greater severity of the complaint.
Measured: change from starting to 0. and 7. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start15 Jan 2018
- Primary completion2 Mar 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Munzur University
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802458
- Sponsor's protocol ID
- 03/09/2018/4579
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Orhan I, Yagmur Y. The effect of motivational interviewing on healthy lifestyle behaviors and quality of life in on menopausal women: a pilot randomized controlled trial. BMC Womens Health. 2025 Jul 4;25(1):306. doi: 10.1186/s12905-025-03807-y.
PubMed 40611241
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Healthy Lifestyle Behaviors and Quality of Life in on Menopausal Women: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06802458
- Acronym / sponsor ID
- 03/09/2018/4579
- Keywords
- motivational interviewing, healthy lifestyle behavior, menopause specific quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Munzur University
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 31 Jan 2025 (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.
Background: This study aims to determine the effect of motivational interviewing on healthy lifestyle behaviors and quality of life in menopausal women.
Methods: This is a randomized controlled empirical study. The study was conducted with a total of 136 women, including 68 for experimental group and 68 for control group. The data were collected using an introductory information form, the Health Promoting Lifestyle Profile II (HPLPL II) and the Menopause-Specific Quality of Life (MENQOL). Women in the experimental group received 6 sessions of motivational interviewing and 2 follow-up interviews in two family health centers (FHCs) from the researcher. No intervention was applied to women in the control group. The data were analyzed using number, percentage, mean, standard deviation, chi-square test, Bonferroni test, independent samples t test and repeated ANOVA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Experimental | Experimental | Other: Motivational interviewing |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- being literate;
- being able to make a conscious decision to participate in the study, being able to communicate verbally, and being able to sign a consent form;
- having had menopause naturally and within the last 3 years;
- being sexually active;
- having no hormone replacement therapy.
Key exclusion criteria (2 listed)
- unwilling to continue the study;
- having a psychiatric diagnosis according to the FHC records.
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 |
|---|---|---|
| Motivational interviewingA total of 9 sessions were conducted, including 1 preparation session, 6 motivational interviews, 1 initial follow-up interview one week after the intervention, and 2 follow-up interviews 4 weeks after the initial follow-up. Considering the interactive training method, the motivational interviewing sessions were conducted in the training room of the Health Center in groups of 10 at three different days (Monday, Thursday, Friday) once a week, through face-to-face sessions each lasting 50-60 minutes. During the interviews, the women were provided with counseling to activate their own sources of motivation, develop healthy lifestyle behaviors and improve their quality of life specific to menopause | Other | Experimental |
Primary outcome
Health Promoting Lifestyle Profile II
Time frame: change from starting to 0. and 7. week
The scale includes six dimensions, namely, nutrition, physical activity, stress management, interpersonal relationships, responsibility for health, and spiritual growth (52 items in total). The items are scored based on a 4 point Likert scale (never, sometimes, often, and usually). The total score of the scale ranges from 52 to 208. The score of each dimension is calculated separately and a higher scores mean better health.
Menopause-Specific Quality of Life
Time frame: change from starting to 0. and 7. week
This is a 7-point Likert-type scale containing 29 items and consists of four domains: vasomotor, psychosocial, physical and sexual. Each item is scored from "0" to "6", where "0" refers to "not bothersome" and "6" to "extremely bothersome". A higher scale score indicates greater severity of the complaint.
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 31 Jan 2025.
- Derived from this study: PubMed 40611241Orhan I, Yagmur Y. The effect of motivational interviewing on healthy lifestyle behaviors and quality of life in on menopausal women: a pilot randomized controlled trial. BMC Womens Health. 2025 Jul 4;25(1):306. doi: 10.1186/s12905-025-03807-y.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Menopause and Nursing, run by Trakya 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 2 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 31 Jan 2025. 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?
Health Promoting Lifestyle Profile II (time frame: change from starting to 0. and 7. week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802458, which also lists 1 linked publication.
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 31 Jan 2025.