Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/04/2016
Date assigned
13/04/2016
Last edited
12/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). An important part of diabetes management maintaining a healthy lifestyle, namely eating well, exercising and taking medication properly. Transtheoretical Model (TTM)–based motivational interviewing is a technique used to change behaviour. It works by progressing gradually through a series of stages so that the patient is able to move from being uninterested or unwilling to change to considering to change and deciding and preparing to make a change. The aim of this study is to find out whether the TTM-based motivational interview method is an effective way of improving self-efficacy, metabolic control, and health behaviour in adults with T2DM.

Who can participate?
Men and women aged between 20 and 65 with type 2 diabetes

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group take part in the TTM-based motivational interview every 15 days or every month (depending on the needs of the individual) for six months. Through these sessions, the interviews focus on blood sugar monitoring, eating well and exercising, and taking medication properly. Participants in the second group continue to receive usual care alone for six months. At the start of the study and again after six months, participants in both groups complete a number of questionnaires in order to assess their lifestyle and self-efficiency, as well as having their blood sugar and weight measured.

What are the possible benefits and risks of participating?
Participants may benefit from being able to change their behaviour, which could have a positive impact on how well they are able to control their blood sugar. There are no notable risks involved with taking part in this study.

Where is the study run from?
Erciyes University Hospital (Turkey)

When is the study starting and how long is it expected to run for?
January 2013 to May 2013

Who is funding the study?
Erciyes University (Turkey)

Who is the main contact?
Dr Alime Selçuk-Tosun
alimetosun@selcuk.edu.tr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alime Selçuk-Tosun

ORCID ID

Contact details

Selcuk University
Faculty of Health Sicence
Konya
42250
Turkey
+90 538 471 5941
alimetosun@selcuk.edu.tr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project No: TDK-2013-4699

Study information

Scientific title

The effect of transtheoretical model–based motivational interview on self-efficacy, metabolic control, and health behavior in adults with type 2 diabetes mellitus: A randomised control study

Acronym

Study hypothesis

Hypotheses:
1. The self-efficacy scores of participants in the intervention and control groups do or do not differ statistically at follow-up
2. The metabolic scores of participants in the intervention and control groups do or do not differ statistically at follow-up
3. The exercise behavior change stages of participants in the intervention and control groups do or do not differ statistically at follow-up
4. The nutrition behavior change stages of participants in the intervention and control groups do or do not differ statistically at follow-up
5. The medication use behavior change stages of participants in the intervention and control groups do or do not differ statistically at follow-up

Ethics approval

Ethics Committee of University Clinical Studies (EUCS), 08/01/2013, ref: 2013/14

Study design

Interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Type 2 diabetes mellitus

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants undergo a 30 to 45 minute TTM-based motivational interview every 15 days or monthly, depending on the participant's individual needs. Motivational interview methods such as expressing empathy, developing discrepancy, rolling with resistance, supporting self-efficacy, avoiding giving advice, providing simple decisional balance, using an importance-confidence scale, using open-ended questions, reflecting, and summarizing are used. Three forms are used in the motivational interviews, namely a blood glucose follow-up table, a medication use and walking form, and a food intake record form, which are used to ensure monitoring of blood glucose levels, medication use, and proper nutrition on a regular basis and to help participants exercise regularly.

Control group: Participants receive no TTM-based motivational interview and continue to receive usual care in the polyclinic.

Participants in both groups are followed up after six months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Self-efficiency is measured using the Self-Efficacy Scale at baseline and six months.

Secondary outcome measures

1. Metabolic values (glycated hemoglobin (HbA1c), weight, body mass index, and waist circumference) is measured taking intravenous blood in the laboratory at baseline and six months
2. Number of steps is measured using a pedometer at baseline and six months
3. Behavior change stage of nutrition, exercise, and medication use is measured using Diagnosis Form for Behavioral Change Stage in Patients with Type 2 Diabetes Mellitus at baseline and six months

Overall trial start date

01/01/2013

Overall trial end date

10/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 2 diabetes mellitus diagnosis for 6 months or longer with hypertension or dyslipidemia
2. Aged between 20 and 65 years
3. Primary school graduates
4. Body mass index (BMI) of 25 kg/m2 or more (overweight or obese)
5. Glycated hemoglobin (HbA1c) level of 7% or more
6. Using oral diabetic medication or insulin or both

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Medical problems that hinder exercise
2. Serious peripheral or autonomic neuropathy
3. Severe retinopathy
4. Psychiatric disorders

Recruitment start date

08/01/2014

Recruitment end date

18/11/2014

Locations

Countries of recruitment

Turkey

Trial participating centre

Erciyes University Hospital
Endocrinology and metabolism polyclinic Feyzioğlu Street No. 42
Kayseri
38039
Turkey

Sponsor information

Organisation

Erciyes University

Sponsor details

The Scientific Research Project Coordination Department
Köşk
Talas Blv
Kayseri
38039
Turkey

Sponsor type

University/education

Website

http://bap.erciyes.edu.tr

Funders

Funder type

University/education

Funder name

Erciyes University (Erciyes Üniversitesi)

Alternative name(s)

Erciyes University

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Turkey

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes