Lifestyle-related ConditionNCT02753491
The Effect of Motivational Short Interview Model in Type 2 Diabetic Patient in Primary Care in TURKEY
A study testing Motivational short interview in people with Lifestyle-related Condition, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Lifestyle-related Condition
- What is being tested?
- Motivational short interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Getting >7 point from beck depression scale for primary care
- Using anti depressed treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
İ̇stanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Lifestyle-related Condition
- Being tested
- Motivational short interview
- Keywords
- short interview, diabetes, lifestyle changes, primary care
- Medical subject headings
- Mental Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational short interviewBehavioural
New designed motivational short interview model
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | In intervention group, three or four motivational short interview made with every participants. Receives: Behavioral: Motivational short interview |
| Control | No intervention | non intervention group, |
What is being measured
The primary outcome is the main question the study is designed to answer.
increasing pedometer levels +1300 step
increasing one week pedometer mean + 1300 step using short interview model
Measured: 3 months
decreasing 300 cal daily food intake
decreasing 300 cal daily food intake using short interview model
Measured: 3 months
Secondary outcomes (2)
increasing short EPAQ category to 2 from 1.
Measured: 3 months
loosing weight
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle-related ConditionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet AKMAN, Asis. Prof., Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753491
- Sponsor's protocol ID
- 09.2015.218
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Short Interview Model in Type 2 Diabetic Paitent in Primary Care in TURKEY
- ClinicalTrials.gov ID
- NCT02753491
- Acronym / sponsor ID
- 09.2015.218
- Conditions
- Lifestyle-related Condition
- Keywords
- short interview, diabetes, lifestyle changes, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Motivational short interviewIn intervention group, three or four motivational short interview made with every participants. |
| Control | No intervention | –non intervention group, |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Getting >7 point from beck depression scale for primary care
- Using anti depressed treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational short interviewNew designed motivational short interview model | Behavioural | Intervention |
Primary outcome
increasing pedometer levels +1300 step
Time frame: 3 months
increasing one week pedometer mean + 1300 step using short interview model
decreasing 300 cal daily food intake
Time frame: 3 months
decreasing 300 cal daily food intake using short interview model
2 secondary outcomes
increasing short EPAQ category to 2 from 1.
Time frame: 3 months
loosing weight
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Lifestyle-related Condition
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet AKMAN, Asis. Prof. study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational short interview in people with Lifestyle-related Condition, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increasing pedometer levels +1300 step (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.