- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02753491
The Effect of Motivational Short Interview Model in Type 2 Diabetic Patient in Primary Care in TURKEY
April 24, 2016 updated by: Marmara University
The Effect of Motivational Short Interview Model in Type 2 Diabetic Paitent in Primary Care in TURKEY
This study designed for primary care practionars for chronic care in primary care.
A new model of motivational short interview used for intervention.
The aim of this study is to develop diet and exercise regimens in type 2 diabetic patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized controlled trial.
The pedometer for one week has given to and filling one day food intake form asked from all participants.
The weights and the heights of the participants were measured and the Beck depression scale for primary care, the modify Moresby scale, the EQ5D, the MDDQ and the motivation scale filled face to face with all participants.
In intervention group the steps of the motivational short interview model were; increase patient awareness about his/her type 2 diabetes and its difficulties, then discuss alternative solutions for the problems the participant has and making decisions for action, and the third and fourth interview includes new alternative solutions for new difficulties if there is and promotion of self efficacy.
Study Type
Interventional
Enrollment (Actual)
163
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
-
-
-
İ̇stanbul, Turkey
- Marmara University School of Medicine
-
-
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
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being type 2 diabetic unless for one year
- No drug changes for last three months
- HbA1c levels between 7-10%
- BMI >25 kg/m2
- At least %80 compliance with medical treatment
- no depression
Exclusion Criteria:
- Getting >7 point from beck depression scale for primary care
- Using anti depressed treatment
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 |
---|---|
Active Comparator: Intervention
In intervention group, three or four motivational short interview made with every participants.
|
New designed motivational short interview model
|
No Intervention: Control
non intervention group,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
increasing pedometer levels +1300 step
Time Frame: 3 months
|
increasing one week pedometer mean + 1300 step using short interview model
|
3 months
|
decreasing 300 cal daily food intake
Time Frame: 3 months
|
decreasing 300 cal daily food intake using short interview model
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
increasing short EPAQ category to 2 from 1.
Time Frame: 3 months
|
3 months
|
loosing weight
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mehmet AKMAN, Asis. Prof., Marmara 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
October 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 24, 2016
First Submitted That Met QC Criteria
April 24, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Estimate)
April 28, 2016
Last Update Submitted That Met QC Criteria
April 24, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 09.2015.218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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