NCT06243939

Brief Summary

This study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration 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

June 6, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

November 15, 2023

Last Update Submit

September 25, 2025

Conditions

Keywords

Pregnancygestational diabetes mellitushealth management self-efficacyquality of lifemotivational interview

Outcome Measures

Primary Outcomes (2)

  • Self-Efficacy Scale in Health Management

    Before and after training between the 24th and 26th weeks of pregnancy

    As the score obtained from the scale increases, self-efficacy for health practices increases.

  • Quality of Life Scale

    Before and after training between the 24th and 26th weeks of pregnancy

    As the total score decreases, the quality of life decreases.

Study Arms (2)

Education

EXPERIMENTAL

24-26 weeks for pregnant women diagnosed with gestational diabetes mellitus. A total of motivational interviews will be held for 4 weeks with the pregnant women. Personal Information Form, Health Management Self-Efficacy Scale and Quality of Life Scale will be administered before the motivational interview, and the Health Management Self-Efficacy Scale and Quality of Life Scale will be administered at the end of the motivational interview.

Behavioral: Motivational Interview to Increase Health Management Self-Efficacy and Quality of Life in Pregnant Women Diagnosed with Gestational Diabetes Mellitus

Control

NO INTERVENTION

24-26 weeks for pregnant women diagnosed with gestational diabetes mellitus. Personal Information Form, Health Management Self-Efficacy Scale and Quality of Life Scale will be applied to the pregnant patient.

Interventions

Motivational interviewing is a client-centered approach used to elicit behavioral change by helping clients explore and resolve their ambivalence.

Education

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being pregnant for the first time
  • Being diagnosed with gestational diabetes mellitus
  • Being in the pregnancy week
  • Being able to speak and understand Turkish
  • Being 18 years or older
  • Having a single and viable fetus
  • Volunteering to participate in research
  • Having and being able to use a mobile phone
  • Having all check-ups at the same hospital and regularly throughout pregnancy,

You may not qualify if:

  • Being diagnosed with diabetes mellitus (type 1, type 2 diabetes) before pregnancy
  • Having a psychiatric diagnosis,
  • Having a chronic disease
  • Having risk factors such as threat of premature birth, placenta previa, premature rupture of membranes
  • Having any disability that would prevent communication (deafness, hearing impairment, etc., use of languages other than Turkish),
  • Pregnant women who do not want to continue the study and give birth before the 37th week of pregnancy will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meltem Akbaş

Adana, Sarıçam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Meltem Akbaş, PhD

    Universty Of Cukurova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 15, 2023

First Posted

February 6, 2024

Study Start

June 6, 2023

Primary Completion

January 30, 2025

Study Completion

September 20, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations