Effectiveness of Life Style Self-Management Interventions Based on Group Cognitive Behavioral Treatment on Life Style, Quality of Life and Metabolic Syndrome Indexes in Adults 30 years and older with Metabolic Syndrome
Determination the Effectiveness of Self-Management Interventions Based on Group Cognitive Behavioral Treatment on Life Style, Quality of Life and Metabolic Syndrome Indexes in Adults with Metabolic Syndrome
Design
Clinical trial with control group, randomized, phase 2 on 80 patients.table of random numbers was used for randomization.
Settings and conduct
For the intervention group: 8 sessions 90-minute group training based on self-management and self-care of metabolic syndrome based on cognitive-behavioral therapy strategies.
For the control group: Routine care and training through booklets and pamphlets Individually and a lecture session.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 30-70 years
Having metabolic syndrome based on the criteria specified in the operational definition of metabolic syndrome
Do not have a known mental disorder such as depression or dementia
Have at least literacy.
Have the ability to take care of yourself.
Have the readiness and satisfaction to participate in the training course.
Output Criteria:
Lack of willingness to continue working together
Absence in more than two sessions of training sessions
Need to change the medical treatment plan.
He should be hospitalized during the research.
Die during research.
Intervention groups
For the intervention group: 8 sessions 90-minute group training based on self-management and self-care of metabolic syndrome based on cognitive-behavioral therapy strategies in observing a healthy diet, mobility, stress control, attention to symptoms and regular screening, self-control, Self-encouragement, self-punishment, self-talk and encouragement by others by example.
For the control group: Routine care and training through booklets and pamphlets and a lecture session.
Main outcome variables
Lifestyle; Quality of Life; Metabolic Syndrome Indexes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200507047343N1
Registration date:2020-05-28, 1399/03/08
Registration timing:retrospective
Last update:2020-05-28, 1399/03/08
Update count:0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Ali Delshad Noghabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 7611
Email address
delshad@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
2020-01-30, 1398/11/10
Actual recruitment end date
2020-04-29, 1399/02/10
Trial completion date
2020-07-20, 1399/04/30
Scientific title
Effectiveness of Life Style Self-Management Interventions Based on Group Cognitive Behavioral Treatment on Life Style, Quality of Life and Metabolic Syndrome Indexes in Adults 30 years and older with Metabolic Syndrome
Public title
Effectiveness of Self-Management Interventions Based on Group Cognitive Behavioral Treatment on Life Style, Quality of Life and Metabolic Syndrome Indexes in Adults with Metabolic Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 70-30 years
with metabolic syndrome, based on the criteria set out in the operational definition of metabolic syndrome,
not suffering from a known mental disorder such as depression and dementia
at least literate
have the necessary ability to take care of themselves
be prepared and satisfied to participate in the training course
Exclusion criteria:
Lack of willingness to continue working together
Absence in more than two sessions of training sessions
Need to change the medical treatment plan
He should be hospitalized during the research
Die during research
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will initially be connivance that first of all adults aged 30 years and older who refer to the comprehensive health service centers of Gonabad city who have the criteria to enter the study based on Specifications Registered in the Integrated Health System First, using the easy sampling method from three comprehensive health service centers in Gonabad, out of 290 adult clients with active care records, 88 people who are eligible to study are selected. Random allocation of the research sample will be done to two intervention and control groups based on quadruple block blocks, so that in each block of 4, two allocations will be allocated to the intervention group and two allocations to the control group. Different ones are created and each block is numbered with one number. The 4 blocks are selected based on a random number table until the sample size reaches 88. In the end, 44 people will be in the control group and 44 people will be in the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants themselves did not know the type of educational intervention, and the data analyst did not know the group due to the data encoding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Nurse Street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-01-27, 1398/11/07
Ethics committee reference number
IR.GMU.REC.1398.160
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
2
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
3
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Lifestyle refers to the score a person receives from the Walker Lifestyle Questionnaire.
Timepoint
At the beginning of the study, three months after the end of the intervention
Method of measurement
Health-Promoting Lifestyle questionnaire
2
Description
Quality of life in this study refers to the score obtained before and three months after the intervention with the WHO Quality of Life Questionnaire (WHOQOL-BREF).
Timepoint
At the beginning of the study, three months after the end of the intervention
Method of measurement
WHO Quality of Life Questionnaire (WHOQOL-BREF)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In this study, lifestyle modification training based on the guidelines of therapeutic strategies in metabolic syndrome: lifestyle interventions to reduce metabolic syndrome and heart disease at Oxford University will be performed in 8 sessions for the Intervention group. In line with the objectives of the study, the self-management intervention training program for lifestyle modification based on group cognitive-behavioral therapy for one month for 8 sessions 90 minutes as two sessions per week as follows for adults 30 years and older with intervention group metabolic syndrome Will be provided.
Category
Behavior
2
Description
Control group: Control group: In the control group, routine care and individual training including booklet, pamphlet and face-to-face training will be provided in connection with the self care of metabolic syndrome and a general magic session.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad Comprehensive Urban Health Services Centers
Full name of responsible person
Ali Delshad Noghabi
Street address
No.4T Imam Khomeini Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
9691977458
Phone
+98 51 5722 7511
Fax
+98 51 5722 3814
Email
delshad@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Nurse Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
9601793718
Phone
+98 51 5722 0575
Fax
+98 51 5722 0575
Email
mmakhosravan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Ali Delshad Noghabi
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 4, Imam Khomeini 2
City
Gonabad
Province
Razavi Khorasan
Postal code
9691977458
Phone
+98 51 5722 7611
Fax
+98 51 5722 3814
Email
delshad@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Reza Esmaeili
Position
Chief of Social Development and Health Promotion Research Center
Latest degree
Ph.D.
Other areas of specialty/work
Health Economy
Street address
Nurse Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 7025
Fax
+98 51 5722 7025
Email
ereza62@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Delshad Noghabi
Position
Associate Professir
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 4, Imam Khomeini 2
City
Gonabad
Province
Razavi Khorasan
Postal code
9691977458
Phone
+98 51 5722 7611
Fax
+98 51 5722 3814
Email
delshad@gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
General information and data analysis
When the data will become available and for how long
At any time
To whom data/document is available
University researchers
Under which criteria data/document could be used
General data analysis
From where data/document is obtainable
Gonabad University of Medical Sciences
What processes are involved for a request to access data/document