Determine the review effect of the family-centered empowerment model on adherence to the diet regimen of elderly patients with type II diabetes mellitus
Design
A clinical trial with an intervention / control / randomized group on 148 patients who were studied for three months.
Settings and conduct
In this study, 148 type 2 diabetic patients were admitted to the experimental and control groups after performing a pretest by random allocation in parallel. A researcher-made questionnaire is used to assess diet awareness and adherence and HbA1C index is used as a metabolic control. Then, the intervention will be performed based on the family-centered empowerment model for the experimental group and after three months, the level of knowledge and the degree of diet adherence will be re-evaluated using a questionnaire and HbA1C values will be measured.
Participants/Inclusion and exclusion criteria
Society: Elderly patients of type 2 and one active family member, inclusion criteria: informed consent, an active member of the patient family and access to the Internet and smartphones, more than three months history of the disease, age 50 years and older, departure: Failure to complete the questionnaire of mental disorders, hospitalization due to other health problems
Intervention groups
Samples are collected from patients referred to clinics in Shushtar city, then the groups are matched and placed in two groups of control and intervention.
Proper diet will be taught.
A researcher-made questionnaire will be used to assess diet awareness and adherence and the HbA1C index will be measured. Intervention will be performed. The process evaluation will be done one week after the intervention and the final evaluation will be done three months after the intervention through a questionnaire.
Main outcome variables
Adherence to diet;
HBA1C index;
Level of knowledge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211018052796N1
Registration date:2022-04-09, 1401/01/20
Registration timing:retrospective
Last update:2022-04-09, 1401/01/20
Update count:0
Registration date
2022-04-09, 1401/01/20
Registrant information
Name
Elham Abdolahi shahvali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3621 5755
Email address
abdolahi-e@shoushtarums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-26, 1400/08/04
Expected recruitment end date
2022-02-23, 1400/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the family-centered empowerment model on adherence to the diet regimen of elderly patients with type II diabetes mellitus
Public title
The effect of family-centered empowerment model on adherence to the diet regimen of elderly patients with type II diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent, an active member of the patient's family and access to the Internet and mobile phone, more than three months of the disease, age 50
Exclusion criteria:
Failure to complete a questionnaire for mental disorders, hospitalization due to other health problems
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Elderly people with type 2 diabetes who were eligible for the study are collected from patients referred to clinics in Shoushtar city in such a way that based on the duration of the disease, age, and sex, the groups are matched and randomly divided into two groups: control and Interventions are placed. Randomization will be carried out using a random number table generated by Excel software and participants will be randomly allocated to one of the two groups. The control group will receive face-to-face education and the intervention groups will receive a 12-week nutrition education intervention in addition to face-to-face education.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shoushtar Faculty of Medical Sciences
Street address
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture.
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.SHOUSHTAR.REC.1399.042
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
HBA1C index
Timepoint
Before the start of the training and three months after the training
Method of measurement
Check the percentage of HBA1C
Secondary outcomes
1
Description
Diet adherence
Timepoint
Before the start of training and three months after
Method of measurement
Completion of the questionnaire
Intervention groups
1
Description
Intervention group: Appropriate diet will be taught by a nutritionist and during nutrition counseling sessions according to the disease status and other underlying diseases of the participants. In these sessions, patients will be taught the glycemic index and glycemic load of carbohydrate foods. You will also be taught how to choose, cook, and process carbohydrate-rich foods to help control your blood sugar levels. It consists of 20 points and is divided into good, medium and poor levels. Will be used and the HbA1C index will be used as a follow-up to the diet, which will be recorded for all samples. For the intervention group, the family-centered empowerment model in four steps; Perceived threat, self-efficacy, self-esteem and evaluation, through group training, group problem solving and training participation, will take place during 3-5 sessions of 30 minutes per week in one of the faculty classes and training cards and training booklets are available. Research and will be an active member of their family. The control group will receive routine care. Patients' competency indicators (perceived threat, self-efficacy and self-esteem) are assessed before the intervention and after the intervention and three months later, but no intervention will be performed in the control group. Leha will act face to face with the patient; and in the same session, the empowerment questionnaire of the active family member will be completed by themselves in the presence of the researcher and if the researcher has a question, after analyzing the data related to the pre-test, intervention in Three steps will be performed for the experimental group in groups of 3-5 people. In the first step, "perceived threat" sessions aimed at increasing the perceived threat by increasing their level of knowledge and awareness about the problems that threaten the patient and the problems and In the first and second sessions, the researcher will explain the nature and process of the disease and its prognosis, the symptoms and the possibility of complications and its consequences, and prevention and treatment strategies, medication regimen, and follow-up treatment plan. The participants themselves continue the discussion and discuss in order to continue learning Training cards will also be used outside of these sessions. Patients will be given educational cards with explanations in simple language and illustrative images in each session related to the topic of discussion. In the second step (self-efficacy through problem-solving), the patient actively participates in the care program while being aware of and deeply aware of the disease process and its complications with confidence and feeling that I can play a role in improving my condition. Problem-solving sessions will be held and problems and problems related to the disease will be discussed through group discussions, such as the correct use of the glucometer. In the third step (self-esteem), the patient was asked to participate in the training of an active family member by conveying the material discussed in each session to the active family member on behalf of the family, and in addition For each session, educational cards will be sent by the researcher to the active member of the family, which contains content and illustrations in plain language and two related questions on the back of the cards. Intervention and final evaluation three months after the intervention through The questionnaire will be implemented. At the end of the work, ie about three months, the awareness questionnaire will be completed again by both groups. The HbA1C of both groups will be measured. They will be analyzed after data collection.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک دیابت بیمارستان خاتم النبیاء شهرستان شوشتر
Full name of responsible person
Elham Abdolahi Shahvali
Street address
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture.
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3621 5755
Email
eabdolahi31@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Elham Abdolahi Shahvali
Street address
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture.
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3621 5755
Email
eabdolahi31@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shooshtar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Elham Abdolahi Shahvali
Position
MSc of nursing, Department of nursing, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture.
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3621 5755
Email
eabdolahi31@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Shirin Amini
Position
PhD in Nutrition, Assistant Professor, Department of Nutrition, Shoushtar Faculty of Medical Science
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture.
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3621 5755
Email
aminishirin83@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Elham Abdolahi Shahvali
Position
MSc of nursing, Department of nursing, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3621 5755
Email
eabdolahi31@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available