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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02753491
Other study ID # 09.2015.218
Secondary ID
Status Completed
Phase N/A
First received April 24, 2016
Last updated April 24, 2016
Start date October 2015
Est. completion date March 2016

Study information

Verified date April 2016
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational short interview
New designed motivational short interview model

Locations

Country Name City State
Turkey Marmara University School of Medicine I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary increasing pedometer levels +1300 step increasing one week pedometer mean + 1300 step using short interview model 3 months No
Primary decreasing 300 cal daily food intake decreasing 300 cal daily food intake using short interview model 3 months No
Secondary increasing short EPAQ category to 2 from 1. 3 months No
Secondary loosing weight 3 months No
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