UMIN-CTR Clinical Trial

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