Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001037392
Ethics application status
Approved
Date submitted
4/05/2017
Date registered
17/07/2017
Date last updated
27/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Educational Intervention Based on Information Motivation Behavioral Skill Model on Self-Care and HbA1c among Type 2 Diabetes Patients in Yemen
Scientific title
Effectiveness of Theory Based Intervention on Self-Care and HbA1c among Type 2 Diabetes Patients in National Center of Diabetes in Yemen
Secondary ID [1] 291774 0
Nil known
Universal Trial Number (UTN)
U1111-1195-9363
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 302999 0
Condition category
Condition code
Metabolic and Endocrine 302462 302462 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Theory based intervention to improve diabetes self care behaviors and HbA1c
The intervention will be designed based on the Information Motivation Behavioral Skill model to address patients’ diet, physical activity and foot care information, motivation, and behavioral skills deficits. Intervention foci will be derived from an extensive review of the literature and lengthy conversations with experts in the field.
The intervention group will receive one session of intervention which will last three hours and the intervention will be conducted in the National Center Of Diabetes in Yemen by the researcher (MBBS, MPH) who is responsible to implement this intervention. All participants in the intervention group will be allocated into small subgroups consisting of twenty participants and each subgroup will be assigned to a specific day The intervention session will include all Information Motivation Behavioral Skills model elements. The Information Motivation Behavioral Skills model is one of recently developed models that provide a framework for a brief health promotion counseling. According to the IMB model improved glycemic control, is function of; individuals information about diabetes self-care behaviors, motivation to engage in self-care implementation & behavioral skills for performing the specific acts involved in self-care activities.
The intervention will include information related to the diet, physical activity and foot care. The researcher will use power point presentation to deliver the information. The researcher will use the discussion to enhance motivation to perform diabetes self-care behaviors (diet, physical activity and foot care). The discussion will include asking open-ended questions, affirming desirable behaviors and negotiating goals that are realistic and attainable. The researcher will use role play technique to give the participants behavioral skills training on how to monitor carbohydrates, integrate physical activity into their lifestyle and how to take care of their feet.

Intervention code [1] 297934 0
Behaviour
Intervention code [2] 298135 0
Treatment: Other
Comparator / control treatment
The control group will receive the usual care, which include a combination of medical treatment, physician monitoring and an optional education session about healthy diet. The control group will be in waiting list to get the intervention which will be at the end of the study after post test data collection. This mean they will receive the intervention 6 months after enrollment.
Control group
Active

Outcomes
Primary outcome [1] 301940 0
Change in the HbA1c
Timepoint [1] 301940 0
Baseline, and at 6 months after intervention
Primary outcome [2] 301941 0
Change in the diabetes self-care behaviors (diet, physical activity, foot care)
Self-care behavior will be assessed with the 11-item Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert, Hampson, & Glasgow, 2000).
Reference:
Toobert, D. J., Hampson, S. E., & Glasgow, R. E. (2000). The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes care, 23(7), 943950.
Timepoint [2] 301941 0
Baseline, and at 6 months after intervention
Secondary outcome [1] 336917 0
Diet information: Information about diet self-care will be measured by 21 items the first 8 items will assess participant's understanding of the impact that carbohydrates have on blood glucose levels, and the importance of eating consistent, controlled amounts of carbohydrates to stabilize blood glucose levels throughout the day. The remaining 13 items will assess participants' knowledge of the types of foods that contain carbohydrates. This measure was developed in a previous study by Osborn (2006).
Osborn, C. Y. (2006). Using the IMB model of health behavior change to promote self-management behaviors in Puerto Ricans with diabetes.
Timepoint [1] 336917 0
Baseline, and at 6 months after intervention
Secondary outcome [2] 336918 0
Physical activity information: Information about physical activity self-care will be measured with seven items assessing the degree to which participants know the benefits of physical activity for blood glucose control and general health (Osborn, 2006).
Timepoint [2] 336918 0
Baseline, and at 6 months after intervention
Secondary outcome [3] 336919 0
Foot care information: In this study ten items scale are developed after a comprehensive review of the literature. This items are (diabetes can cause loss of sensation in the feet, diabetes patients may injure their feet without knowing, diabetes patients should inspect their feet daily, diabetes patients should wash their feet daily, diabetes patients should dry their feet and between the toes after washing, diabetes patients should moisturize their feet, diabetes patients should moisturize between the toes, diabetic patients should test water before putting their feet in it, it is right if diabetic patient walk barefoot, diabetic patients should check inside their shoes before wearing them).
Timepoint [3] 336919 0
Baseline, and at 6 months after intervention
Secondary outcome [4] 336920 0
Diet attitude: Diabetes-relevant diet attitudes will be measured with 10 items that asked, in the next 30 days, how good - bad, and then how pleasant - unpleasant would it be to eat three meals each day, eat the same amount at each meal, and monitor carbohydrate intake at each meal (Osborn, 2006).
Timepoint [4] 336920 0
Baseline, and at 6 months after intervention
Secondary outcome [5] 336921 0
Physical activity attitudes: Diabetes-relevant physical activity attitudes will be measured with 6 items that asked, in the next 30 days, how good - bad, and then how pleasant - unpleasant would it be to exercise, go for a walk, and add activity to the things you already do (Osborn, 2006).
Timepoint [5] 336921 0
Baseline, and at 6 months after intervention
Secondary outcome [6] 336922 0
Foot care attitude: In this study, 12 items are developed to measure the foot care attitude. These items ask that, in the next 30 days, how good - bad, and then how pleasant - unpleasant would it be to inspect your feet daily, wash your feet daily, dry your feet and between the toes after washing, moisturize your feet, test water before putting your feet in it, check inside your shoes before wearing them.
Timepoint [6] 336922 0
Baseline, and at 6 months after intervention
Secondary outcome [7] 336923 0
Diet subjective norms: Diabetes-relevant diet subjective norms will be measured with 5 statements, Most people who are important to me think I should eat three meals each day, eat the same amount at each meal, monitor carbohydrate intake at breakfast, monitor carbohydrate intake at lunch, and monitor carbohydrate intake at dinner (Osborn, 2006).
Timepoint [7] 336923 0
Baseline, and at 6 months after intervention
Secondary outcome [8] 336924 0
Physical activity subjective norms: Diabetes relevant physical activity subjective norms will be measured with 3 statements, most people who are important to me think I should exercise, walk for exercise, and add activity to the things I already do (Osborn, 2006).
Timepoint [8] 336924 0
Baseline, and at 6 months after intervention
Secondary outcome [9] 336925 0
Foot care subjective norms: In this study, six items are developed to assess the diabetes relevant foot care subjective norms. These items state that, most people who are important to me think I should inspect my feet daily, wash my feet daily, dry my feet and between the toes after washing, moisturize my feet, test water before putting my feet in it, check inside my shoes before wearing them.
Timepoint [9] 336925 0
Baseline, and at 6 months after intervention
Secondary outcome [10] 336926 0
Diabetes-relevant diet behavioral skills will be measured with 8 items. The first 3 items asked, how easy or hard would it be for you to eat breakfast every day, eat three meals each day, and eat the same amount at each meal. (Osborn, 2006).
Timepoint [10] 336926 0
Baseline, and at 6 months after intervention
Secondary outcome [11] 336927 0
Physical activity behavioral skills: Diabetes-relevant physical activity behavioral skills will be measured with 6 items. The first 3 items asked, how easy or hard would it be for you to create different exercise activities to do in your home, pick a convenient time of day to exercise, and start exercising again when you have not exercised in a long time (Osborn, 2006).
Timepoint [11] 336927 0
Baseline, and at 6 months after intervention
Secondary outcome [12] 336928 0
Foot care behavioral skills: In this study, 12 items are developed to assess the diabetes-relevant foot care behavioral skills. The first 6 items asked, how easy or hard would it be for you to inspect your feet daily, wash your feet daily, dry your feet and between the toes after washing, moisturize your feet, test water before putting your feet in it, check inside your shoes before wearing them.
Timepoint [12] 336928 0
Baseline, and at 6 months after intervention

Eligibility
Key inclusion criteria
The eligible participants are male and female Yemeni patients their age 18 years or older and had a clinical diagnosis of type 2 diabetes mellitus for at least one year and their HbA1c is between 7% and 12%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they will not give consents, have severe diabetes complications, cognitive impairment, or pregnant woman.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed envelopes will be used to conceal the randomization sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the randomization sequence will be created by using computer software program that generates the random sequences with a 1:1 allocation using random block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All analyses will be performed using SPSS version 23, P-value less than 0.05 will be considered as significant and intention to treat analysis will be used to analyze the data. ANCOVA and MANCOVA models will be used to test the intervention effectiveness on diet, physical activity and foot care behavior, HbA1c and diet, physical activity and foot care information, motivation, and behavioral skills.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2017
Actual
1/02/2018
Date of last participant enrolment
Anticipated
31/12/2017
Actual
28/02/2018
Date of last data collection
Anticipated
1/07/2018
Actual
15/09/2018
Sample size
Target
242
Accrual to date
Final
246
Recruitment outside Australia
Country [1] 8860 0
Yemen
State/province [1] 8860 0
Sana'a

Funding & Sponsors
Funding source category [1] 296277 0
Self funded/Unfunded
Name [1] 296277 0
Country [1] 296277 0
Primary sponsor type
University
Name
University Putra Malaysia
Address
Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 295192 0
Hospital
Name [1] 295192 0
Al-Thawra Modern General Hospital
Address [1] 295192 0
Talha St, Sana'a, Yemen
Country [1] 295192 0
Yemen

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297510 0
JKEUPM (ETHIC COMMITTEE FOR RESEARCH INVOLVING HUMAN SUBJECT)
Ethics committee address [1] 297510 0
Ethics committee country [1] 297510 0
Malaysia
Date submitted for ethics approval [1] 297510 0
28/10/2016
Approval date [1] 297510 0
07/02/2017
Ethics approval number [1] 297510 0
FPSK(FR16)015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74274 0
Dr Abeer Yahya Ahmed Al-Washali
Address 74274 0
A-13-4, ARENA GREEN APARTMENT
JALAN 1/155A BUKIT JALIL
57000 KUALA LUMPUR
Country 74274 0
Malaysia
Phone 74274 0
+60108977893
Fax 74274 0
Email 74274 0
[email protected]
Contact person for public queries
Name 74275 0
Hejar Abdul Rahman
Address 74275 0
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UM Serdang, Selangor DE,
Country 74275 0
Malaysia
Phone 74275 0
+60122362351
Fax 74275 0
Email 74275 0
[email protected]
Contact person for scientific queries
Name 74276 0
Abeer Yahya Ahmed Al-Washali
Address 74276 0
A-13-4, ARENA GREEN APARTMENT
JALAN 1/155A BUKIT JALIL
57000 KUALA LUMPUR
Country 74276 0
Malaysia
Phone 74276 0
+60108977893
Fax 74276 0
Email 74276 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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