Motivational Interviewing on Healthy Lifestyle Behaviors and Quality of Life in on Menopausal Women

January 24, 2025 updated by: Burcu KUCUKKAYA, Trakya University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • 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
      • Tunceli, Turkey
        • Munzur University

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. being literate;
  2. 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;
  3. having had menopause naturally and within the last 3 years;
  4. being sexually active;
  5. having no hormone replacement therapy.

Exclusion Criteria:

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Experimental
Other: Motivational interviewing
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from starting to 0. and 7. week
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.
change from starting to 0. and 7. week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Collaborators

Munzur 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)

January 15, 2018

Primary Completion (Actual)

March 2, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03/09/2018/4579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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