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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041152
Receipt No. 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 2020/07/19

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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
Email 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
Email najwa-asu@outlook.com

Sponsor
Institute Universiti Putra Malaysia
Institute
Department

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
Email 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 No longer recruiting
Date of protocol fixation
2019 Year 04 Month 28 Day
Date of IRB
2019 Year 04 Month 28 Day
Anticipated trial start date
2019 Year 04 Month 28 Day
Last follow-up date
2020 Year 03 Month 12 Day
Date of closure to data entry
2020 Year 03 Month 12 Day
Date trial data considered complete
2020 Year 03 Month 12 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 19 Day
Last modified on
2020 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046535

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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