NCT06802458

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 17, 2025

Last Update Submit

January 24, 2025

Conditions

Keywords

motivational interviewinghealthy lifestyle behaviormenopause specific quality of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    change from starting to 0. and 7. week

Study Arms (2)

Control

NO INTERVENTION

Experimental

EXPERIMENTAL
Other: Motivational interviewing

Interventions

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

Experimental

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • unwilling to continue the study;
  • having a psychiatric diagnosis according to the FHC records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munzur University

Tunceli, Tunceli, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Women's Health and Disease Nursing

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 31, 2025

Study Start

January 15, 2018

Primary Completion

March 2, 2018

Study Completion

June 15, 2018

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations