NCT06727123

Brief Summary

Diabetes is a chronic metabolic disorder characterized by high blood sugar due to problems with insulin production or function. Its prevalence has increased significantly in recent decades due to sedentary lifestyles, unhealthy diets, and increasing obesity rates. Type 2 diabetes, in particular, is a major global and national health problem with projections showing that it continues to grow. Effective diabetes management requires patients to adopt healthy behaviors such as following a diet plan, monitoring blood sugar, increasing physical activity, and avoiding risky habits such as smoking. Inadequate adherence to treatment can lead to serious complications such as cardiovascular disease and kidney damage, which can be a burden to patients, families, and healthcare systems. Motivational interviewing, a patient-centered approach, helps individuals overcome resistance to behavioral change. This study was designed experimentally to determine the effect of motivational interviewing on diabetes self-management in patients with type 2 diabetes.

Trial Health

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Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
1mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress92%
Dec 2024Jun 2026

First Submitted

Initial submission to the registry

December 6, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 6, 2024

Last Update Submit

December 6, 2024

Conditions

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Diabetes Self-Management

    Type 2 Diabetes Self-Management Scale

    6 months

Secondary Outcomes (1)

  • HbA1c

    6 months

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Motivational interviews will be conducted with diabetic patients for 6 months. Patients will be trained before starting the interviews.

Other: motivational interviewing

Control

EXPERIMENTAL

No application will be made. Routine follow-ups will be made.

Other: Control

Interventions

Motivational interviews will be conducted with diabetic patients for 6 months. Patients will be trained before starting the interviews.

Motivational Interviewing
ControlOTHER

No application will be made. Routine follow-ups will be made.

Control

Eligibility Criteria

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

You may qualify if:

  • Individuals who agree to participate in the study voluntarily, can speak and understand Turkish, can communicate comfortably, have no hearing, comprehension or vision problems, are literate, use a smartphone, have Type 2 Diabetes and have HbA1c ≥ 7% will be included in the study.

You may not qualify if:

  • Patients with cognitive dysfunction and those using antipsychotic medication will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Beykent University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 10, 2024

Study Start

December 20, 2024

Primary Completion

December 20, 2025

Study Completion (Estimated)

June 20, 2026

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations