- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05030844
The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With T2DM
October 1, 2022 updated by: EDA KILINÇ, Pamukkale University
The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With Type 2 Diabetes-A Randomized Controlled Study: Randomized Controlled Trial
This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing interventions on care outcomes for adults with Type 2 diabetes (diabetes knowledge, health belief, self-efficacy, self-management, HbA1c and BKİ).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was conducted to examine the effects of Information, Motivation and Behavioral Skills (IMB) model-based diabetes education and motivational interviewing on care outcomes in adults with Type 2 diabetes.
The study is a single-blind, randomized controlled trial with pre-test, post-test and follow-up test measurements from experimental research designs.
The study was carried out in the Endocrinology and Metabolic Diseases Polyclinic, and the data were collected between June 2021 and February 2022.
The sample of the study (intervention group=30, control group=30) consisted of 60 individuals with type 2 diabetes.
Study data were collected with Adult Diabetes Information Scale, Health Belief Model Scale, Diabetes Self-Efficacy Scale, Diabetes Self-Management Scale and metabolic control parameters follow-up form.
IMB model-based diabetes education and motivational interview program were applied to the individuals in the experimental group for three months.
Initially, diabetes education was given in small groups in four sessions, then Motivational Interviews were held individually every two weeks for a total of five sessions via WhatsApp.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Denizli, Turkey
- Pamukkale University
-
-
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
30 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Those between the ages of 30-64
- Receiving insulin therapy
- BMI value of 25 and above
- HbA1c of 7 and above
- At least primary school graduate and can speak Turkish
- No communication barrier (speech, vision or hearing problem)
- Having a smart phone and internet access
- Individuals who agree to participate in the research.
Exclusion Criteria:
- Those who have retinopathy at a level that may hinder the sense of sight.
- Those with neuropathy at a level that prevents them from doing their daily physical activities
- Diagnosed with kidney failure
- Using an insulin pump
- Pregnant
- Those with a diagnosis of cancer
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 |
---|---|
No Intervention: Control Group
The control group received routine nursing care in the endocrine policlinic.
|
|
Experimental: Intervention Group
IMB model-based interventions were applied to the intervention group for 3 month.
For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks.
Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers.
For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week.
|
IMB model-based interventions were applied to the intervention group for 3 month.
For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks.
Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers.
For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in diabetes knowledge level of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Knowledge Scale.
Time Frame: baseline, 3rd month and 6 rd month
|
This scale was used to measure the knowledge component in the IMB model of individuals.
The scale was developed by Erener Yavuz and Erol (2019) to measure the knowledge level of adults with diabetes.
The scale consists of 5 sub-dimensions, including General Information on Diabetes (6 items), Blood Glucose Measurements and Values (5 items), Diabetes Risk Factors (4 items), Diabetes Symptoms (8 items), Diabetes Complications (5 items), and 28 consists of matter.
Scale answers consist of two sets of items, true and false.
Among the yes/no/don't know answer type questions, 1 point is given to those who give correct answers, 0 points are given to those who do not know and give wrong answers.
The maximum score that can be obtained from the scale is 28, and the minimum score is 0.
|
baseline, 3rd month and 6 rd month
|
The change in diabetes health belief of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Health Belief Model Scale in Diabetes Patients.
Time Frame: baseline, 3rd month and 6 rd month
|
This scale was used to measure the individual motivation component in the IMB model of individuals.
The scale consists of 5 sub-dimensions and 33 items: perceived sensitivity (4 items), perceived seriousness (3 items), perceived benefits (7 items), perceived barriers (9 items), recommended health-related activities (10 items).
The mean score of each sub-dimension is determined by dividing the total scores of all items in the sub-dimension by the total number of items.
The total scale mean score is calculated by dividing the total scores of all scale items by the total number of items.
The minimum score for each item is 1 and the maximum score is 5. Rating was made as strongly disagree (1), strongly agree (5).
Low scores indicate negative and high scores indicate positive health beliefs.
If the mean score for each item is 4 and above, it indicates high or positive health belief, and if the mean score is less than 4, it indicates low health belief.
|
baseline, 3rd month and 6 rd month
|
The change in diabetes self efficacy of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Efficacy Scale.
Time Frame: baseline, 3rd month and 6 rd month
|
The "Self-Efficacy Scale" for diabetes management in type 2 diabetes patients was developed to determine the perception of diabetes patients' own power to carry out their own care activities.
The items that make up the scale are based on the following activities.
Activities to be done for diabetes treatment (drug use, diet, physical exercise), self-monitoring, self-control (knowing the value of blood sugar, body weight, foot control, general health), regulating their own activities (hypoglycemia, hyperglycemia correction, preparing for vacation) change in diet, overweight, self-control in case of illness and stress).
The scale consists of 20 items.
The lowest score to be taken from the scale is 20, and the highest score is 100.
|
baseline, 3rd month and 6 rd month
|
The change in diabetes self managament of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Management Scale
Time Frame: baseline, 3rd month and 6 rd month
|
This scale was used to measure the behavioral component of individuals in the IMB model.
The validity and reliability study of the Turkish Diabetes Self-Management Perception Scale was conducted by Eroğlu and Sabuncu (2018).
The scale consists of 16 items and 4 sub-dimensions and is a 4-point Likert type.
Glucose Management sub-dimension: Items 4, 6, 10, 12 (items 4 and 12 are about drug use, items 1, 6 and 10 are about blood glucose monitoring).
Diet Control sub-dimension: Items 2, 5, 9, 13.
Physical Activity sub-dimension: Items 8, 11, 15.
Use of Health Services sub-dimension: It consists of 3, 7, 14, and 16 items.
The DMS scale consists of 16 items, 7 of which are straight and 9 of which are reversed.
The scores of the items numbered "5, 7, 10, 11, 12, 13, 14, 15 and 16" in the scale are calculated by reversing them.
Diabetes self-management increases as the score gets closer to 10.
|
baseline, 3rd month and 6 rd month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic control variables
Time Frame: baseline, 3rd month and 6 rd month
|
Measurement of changes in HbA1c and Body Mass Index levels of individuals with Type 2 diabetes at 3rd month and 6 rd month
|
baseline, 3rd month and 6 rd month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 14, 2021
Primary Completion (Actual)
October 14, 2021
Study Completion (Actual)
February 14, 2022
Study Registration Dates
First Submitted
August 30, 2021
First Submitted That Met QC Criteria
August 30, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
October 1, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKILINC
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
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.
Clinical Trials on BMI
-
Oklahoma State University Center for Health SciencesNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
University of MinnesotaCompleted
-
National Cancer Institute (NCI)CompletedBMI | General Demographics CharacteristicsCosta Rica
-
United States Army Research Institute of Environmental...Recruiting
-
Parc de Salut MarNeuroelectrics CorporationCompletedObesity, Morbid | Obesity (BMI > 35) and Diabetes Mellitus | Obesity (BMI > 35) and High Blood Pressure | Obesity (BMI > 35) and Dyslipemia
-
Ahlia UniversityCompletedBMI, Academic Stress and MSDs Relationships
-
University of SalernoCompletedObesity With BMI >35
-
University of MinhoUniversidade do PortoCompletedEvidence of an Intervention on Childhood BMI z ScorePortugal
-
University Hospital, Clermont-FerrandUnknown
Clinical Trials on IMB model based Diabetes Education and Motivational Interviewing
-
Aslı MemisNot yet recruitingAdolescent | Behavior, Addictive | Motivation | Digital TechnologyTurkey
-
Massachusetts General HospitalCompletedType 2 Diabetes MellitusUnited States
-
Mustafa YumusakCumhuriyet UniversityNot yet recruitingSmartphone Addiction | Students, NursingTurkey
-
Selcuk UniversityCompletedMotivation | Breastfeeding | Self-Efficacy | SuccessTurkey
-
Central South UniversityCompletedDepression | Coronary Heart Disease
-
Semra TUNCAY YILMAZSemra TUNCAY YILMAZCompletedParenting | Maternal-Fetal Relations | Paternal BehaviorTurkey
-
Gümüşhane UniversıtyKaradeniz Technical UniversityRecruiting
-
Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Recruiting
-
Inonu UniversityCompletedQuality of Life | Type 2 Diabetes Mellitus | Motivational Interviewing | Self-Management | Mobile Technology | GamingTurkey
-
Massachusetts General HospitalCompletedType2 DiabetesUnited States