UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041152 |
|---|---|
| Receipt number | R000046535 |
| Scientific Title | Effects of health education intervention on diabetes control and cardiovascular risk modification among patients with type 2 diabetes mellitus patients in muscat, Oman |
| Date of disclosure of the study information | 2020/08/30 |
| Last modified on | 2021/01/17 22:42:24 |
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Basic information
Public title
Effects of health education intervention on diabetes control and cardiovascular risk modification among patients with type 2 diabetes mellitus patients in muscat, Oman
Acronym
Effects of health education intervention on diabetes control and cardiovascular risk modification among patients with type 2 diabetes mellitus patients in muscat, Oman
Scientific Title
Effects of health education intervention on diabetes control and cardiovascular risk modification among patients with type 2 diabetes mellitus patients in muscat, Oman
Scientific Title:Acronym
Effects of health education intervention on diabetes control and cardiovascular risk modification among patients with type 2 diabetes mellitus patients in muscat, Oman
Region
| Asia(except Japan) |
Condition
Condition
Clinical trials
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of the health education intervention on diabetes control and cardiovascular risk among type 2 diabetes patients in Muscat, Oman.
Basic objectives2
Others
Basic objectives -Others
1. To determine the following characteristics of patients with type 2 diabetes at baseline:
Sociodemographic characteristics (age, education level, sex, marital status, income)
Clinical factors (presence of diseases, duration of illness, medication, etc)
Dietary intake (macronutrients and micronutrients), dietary pattern and Mediterranean Diet Score
Lifestyle characteristics (smoking, alcohol consumption, physical activity level, sleep quality)
Anthropometric measurements
Risk of cardiovascular (blood pressure, high density lipoprotein cholesterol, low density lipoprotein cholesterol, ratio of total cholesterol to high density lipoprotein cholesterol, and triglycerides level)
2. To compare the mean difference in:
Mediterranean diet score, dietary intake, physical activity, anthropometric measurements, risk of cardiovascular, within and between control and intervention groups at three months (post-intervention 1) and six months (post-intervention 2) after intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes:
Decrease the Risk of cardiovascular:
HbA1c
Blood lipid profile (TG, LDL HDL, Total cholesterol/ HDL ratio)
Blood pressure (Systolic and diastolic)
Anthropometric measurements (Body mass index)
Key secondary outcomes
Secondary outcomes:
psychosocial factors
dietary behaviors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
67/67
Interventions/Control_2
67/67
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for current study were Omani men and women aged 18 to 75 years old, diagnosed with Type 2 diabetes, and receiving diabetes care from the NDEC with stable HbA1c less than 10% for at least 6 months.
Key exclusion criteria
Men and women who were severely impaired in vision, hearing, or speech. Additionally, Pregnant or lactating women and individuals who are diagnosed with cardiac failure or/and severe renal disease, with physical or mental disability, neurological or cognitive impairment. Individuals who have known allergy to peanuts/ or any components of the Mediterranean diet were excluded also.
Control group will be invited to the clinic in different days / clinic slots to avoid any possibility of contamination between them and intervention subjects. In addition, subjects in the control group will be assured that they will receive the same information as the intervention subjects at the end of the study.
In order to avoid any risks, patients with any type of known allergies related to Mediterranean diet will be excluded from the study. Subjects will be advised on potential symptoms of allergies. Clear instruction will be provided that subjects presented with allergies symptoms will need to seek medical treatment immediately.
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | Najwa |
| Middle name | Salim |
| Last name | AlAufi |
Organization
Universiti Putra Malaysia
Division name
Department of Nutrition and Dietetics
Zip code
43400
Address
Jalan University, serdang, selangor, malaysia
TEL
0096871729525
najwa-asu@outlook.com
Public contact
Name of contact person
| 1st name | Najwa |
| Middle name | Salim |
| Last name | AlAufi |
Organization
Universiti Putra Malaysia
Division name
Department of Nutrition and Dietetics
Zip code
43400
Address
Jalan University, serdang, selangor, malaysia
TEL
0096871729525
Homepage URL
najwa-asu@outlook.com
Sponsor or person
Institute
Universiti Putra Malaysia
Institute
Department
Personal name
Funding Source
Organization
Universiti Putra Malaysia
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universiti Putra Malaysia
Address
Jalan University, serdang, selangor, malaysia
Tel
0096871729525
najwa-asu@outlook.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
126
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046535
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