Protocol summary
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Study aim
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The Comparison of the Effects of Two Educational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
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Design
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Three parallel group randomized trial which 378 patients participated.
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Settings and conduct
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This study was performed in the diabetic clinic affiliated to Ahvaz University of Medical Sciences. Participants were allocated to oral education group, video education group and control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria to the study: Eighteen years or older; being able to spoke in Farsi or Arabic.
Exclusion criteria to the study: Having other chronic diseases; having visual, hearing, and speech impairments; being pregnant.
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Intervention groups
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Participants were allocated to verbal education, video education, and control groups. The participants in the oral education group received four educational sessions during a two-week interval. The participants in the video education group received educational movie.
Also, an abstract of the educational content was provided to the participants of oral education group in writing for home use. The educational movie was provided to the participants of video education group in the form of DVDs for home use.
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Main outcome variables
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Patients' weight and Biochemical parameters (such as Fasting Blood Sugar (FBS), Glycated hemoglobin (HbA1c), Total Cholesterol (TC), Triglyceride Levels (TG), low-Density Lipoprotein (LDL), and High Density Lipoprotein (HDL))
General information
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Reason for update
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Added more details.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150302021307N4
Registration date:
2020-03-24, 1399/01/05
Registration timing:
retrospective
Last update:
2021-03-24, 1400/01/04
Update count:
2
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Registration date
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2020-03-24, 1399/01/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-17, 1398/11/28
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Expected recruitment end date
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2020-03-05, 1398/12/15
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Actual recruitment start date
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2020-02-17, 1398/11/28
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Actual recruitment end date
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2020-03-05, 1398/12/15
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Trial completion date
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2020-03-10, 1398/12/20
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Scientific title
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The Comparison of the Effects of Two Educational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
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Public title
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The Comparison of Two Educational Programs on Dietary Regimen Compliance in Patients with Diabetes
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Eighteen years or older
Being able to spoke in Farsi or Arabic
Exclusion criteria:
Having other chronic diseases
Having visual, hearing, and speech impairments
Being pregnant
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
378
Actual sample size reached:
364
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomized in a 1:1:1 ratio using a permuted block method with varying block sizes to video education, oral education, or control group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Data analyzer and those assessing the outcomes were blinded. we gave a code to the each study group and they did not know each patient was in which groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-17, 1398/11/28
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Ethics committee reference number
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IR.AJUMS.REC.1398.901
Health conditions studied
1
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Description of health condition studied
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Diabetes
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ICD-10 code
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E 11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Fasting blood sugar (FBS)
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Timepoint
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2 days before the intervention was measured. The laboratory index was measured again 90 days later.
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Method of measurement
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After fasting for 12 hours using laboratory Kit was measured.
2
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Description
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Lipid profile (TG, Cholesterol, LDL, and HDL)
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Timepoint
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2 days before the intervention were measured. The laboratory indices were measured again 90 days later.
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Method of measurement
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After fasting for 12 hours using laboratory Kit were measured.
3
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Description
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Glycated hemoglobin (HbA1c)
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Timepoint
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2 days before the intervention was measured. The laboratory index was measured again 90 days later.
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Method of measurement
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After fasting for 12 hours using laboratory Kit was measured.
4
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Description
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Patients' weight
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Timepoint
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2 days before the intervention was measured. The patients' weight was measured again 90 days later.
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Method of measurement
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The patients' weight was measured using a digital scale.
Intervention groups
1
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Description
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First intervention group: The participants in the oral education group received 4 educational sessions during a two-week interval. The educational program was implemented in a quiet conference room. Each session was 45-minute.
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Category
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Lifestyle
2
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Description
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Second intervention group: The participants in the video education group received educational movie. The educational movie was displayed in two sessions during a two-week interval. The total movie length was two hours.
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Category
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Lifestyle
3
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Description
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Control group: The participants in the control group received routine care and a educational pamphlet by clinical nurses.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The data file will be subscribed to by the SPSS software format. Only the original outcome can be shared.
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When the data will become available and for how long
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The start of the access period is 12 months after the publication of the results and for 3 months.
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To whom data/document is available
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Data will only be available to researchers working in academia.
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Under which criteria data/document could be used
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Data will only be available for use in review and meta-analyzes studies.
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From where data/document is obtainable
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Mojtaba Miladinia Academic email: miladinia.m@ajums.ac.ir
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What processes are involved for a request to access data/document
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First, send an e-mail to the author and mention the purpose of obtaining the information. In the absence of a problem, you will receive information one to three weeks later.
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Comments
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