NCT02753491

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 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

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

April 24, 2016

Last Update Submit

April 24, 2016

Conditions

Lifestyle-related Condition

Keywords

short interview, diabetes, lifestyle changes, primary care

Outcome Measures

Primary Outcomes (2)

  • increasing pedometer levels +1300 step

    increasing one week pedometer mean + 1300 step using short interview model

    3 months

  • decreasing 300 cal daily food intake

    decreasing 300 cal daily food intake using short interview model

    3 months

Secondary Outcomes (2)

  • increasing short EPAQ category to 2 from 1.

    3 months

  • loosing weight

    3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

In intervention group, three or four motivational short interview made with every participants.

Behavioral: Motivational short interview

Control

NO INTERVENTION

non intervention group,

Interventions

Motivational short interviewBEHAVIORAL

New designed motivational short interview model

Intervention

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Getting \>7 point from beck depression scale for primary care
  • Using anti depressed treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

İ̇stanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental DisordersDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mehmet AKMAN, Asis. Prof.

    Marmara University

    STUDY DIRECTOR

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
SPONSOR

Study Record Dates

First Submitted

April 24, 2016

First Posted

April 28, 2016

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)