Determining the effect of multidisciplinary brief intervention on reduction of cardio-metabolic risk factors in women.
Design
In this randomized controlled clinical trial, with parallel groups, 110 women with cardio metabolic-syndrome who are eligible to enter the study, will be assigned into one of the intervention or control groups by randomized blocking method.
Settings and conduct
110 included women with cardio-metabolic syndrome referring Shahid Madani and Shahid Rahimi Hospital in Khorramabad, will be allocated into two groups of intervention and control. At the beginning of the study, all subjects of the two groups will complete the research questionnaires. Then, in the intervention group, the multidisciplinary intervention will be performed in three telephone follow-up and three visits. The control group would not receive any intervention from the researcher. After completing the intervention, research questionnaires will be completed for both groups and the results will be compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Women aged 18-75. 2) Risk factor of cardio-metabolic. 3) Level of 3, 4, 5 triage. 5) Having at least 60 minutes per week physical activity for three months. Exclusion criteria: 1) Getting with a severe psychological illness. 2) Chronic diseases. 3) Getting covid 19.
Intervention groups
The intervention with focus on three components of motivational interviewing, motivational feeding consulting and motivational physical activity consulting includes three personal visits during admission and hospitalization in the hospital and three telephone calls follow up in the second and fourth and eighth week after discharge , provided by the multidisciplinary team. In control group, the routine care method of the emergency department is generally performed.
Main outcome variables
cardio-metabolic risk factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150919024080N21
Registration date:2022-02-20, 1400/12/01
Registration timing:registered_while_recruiting
Last update:2022-02-20, 1400/12/01
Update count:0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Multidisciplinary Brief Intervention on Reduction of Cardio- Metabolic Risk Factors in Women Admitted to the Emergency Department
Public title
The Effect of Multidisciplinary Brief Intervention on Reduction of Cardio- Metabolic Risk Factors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with metabolic heart disease aged 18 - 75
Patient with moderate to high risk and with two risk factor of cardiometabolic according to risk assessment scale (prediabetic situation or metabolic syndrome)
Exposure in the level of 3, 4, 5 ESI triage
Ability to understand andperception Persian language
Willingness and consent to participate in research and to complete the form of research ethics
Admission and accommodation in the emergency department for at least 24 hours and having a medical record
Psychological disorder, such as severe mood disorders
BMI>27 (in the weight of overweight and obese)
On average , more than 60 minutes per week physical activity (moderate and severe) has occurred over the past three months
Having a fixed phone or cell phone
Exclusion criteria:
getting with a severe psychological illness after the diagnosis of the disease.
the present experience of cardiovascular disease like dyspnea or tachycardia
Chronic diseases such as renal failure , liver failure
getting viral disease and acute infected disease such as covid 19
Patients at the risk of suicide according to the Nurses Global Assessment of Suicide Risk criteria .
Heart Rate<60 AND Heart Rate>100
Systolic Blood Pressure>160 AND Diastolic Blood Pressure>100
Engagement in other counseling programs and changing behavior for lifestyle
hospitalization for more than a week
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
In order to unify the important distribution of age and education, class based on these variables related to pre menopause/post menopause, a diploma/ high diploma, and then a block random method (Block randomization) in two studies groups are balanced. It should be noted that the volume of each block is 4, which makes six different combinations of block (4 blocks) and choose random selection by placing blocks. Using this method the sample volume will be equal to the two study arms and the difference between the two groups in terms of sample volume will be equivalent to half the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding groups as a ( intervention group ) and b ( control group ) are performed by a nursing that does not play a role in the study. The code occasionally runs to the independent nurse until the end of the data analysis. Data analyst and evaluation nurse are unaware of the random allocation of groups in the control and intervention groups. Participants prior to randomization become aware of their possible allocation in one of the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan Medical Sciences Ethics Committee
Street address
Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
987654321
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.LUMS.REC.1399.364
Health conditions studied
1
Description of health condition studied
Cardio-metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Cardiometabolic risk
Timepoint
Before starting treatment and after completing the 60 day treatment period
Method of measurement
FINDRISK tool
2
Description
Physical activity
Timepoint
Before starting treatment and after completing the 60 day treatment period
Method of measurement
Short International Physical Activity questionnaire
3
Description
Mediterranean diet score
Timepoint
Before starting treatment and after completing the 60 day treatment period
Method of measurement
Modified Mediterranean diet score questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: After accepting the patient in the emergency department and choosing the sample based on the criterion of entry into intervention, a brief intervention takes place in this form.The intervention is focused on three components of the motivational interview , the motivational counseling and motivational counseling of the physical activity , including three individual visits and three phone calls .which is being offered by a multi - professional team within eight weeks includes medical professionals , trained nurses about motivational interviewing ( senior undergraduate , main researcher ) as well as a nutritionist .The intervention program contains the intervention program for three individual visits and three phone follow - up, as described below. First visit to the evocative interview• : taking a history of the client and determining risk factors are done by findrisk questionnaire . Then the evocative interview is performed according to the frames model considering six steps including feedback , responsibility , recommendation , list of options , empathy , and work . Second visit to the feeding motivational counseling: the face visit to the second one ( according to the patient 's desire ) after the first visit was done by the nutritionist and by the presence of the main researcher and preferably the patient 's family for a period of thirty - eight minutes . the question about the eating habits of the patient and family , the initial assessment of the patient 's nutritional status , weight and eating disorder and providing explanations concerning the intake of a healthy diet and the importance of food intake , explanation and interpretation of the food label are the contents of this visit . A third visit to the motivational orientation of the physical activity: A third - to - face visit lasts from 6 to 24 hours ( according to the patient " s inclination ) after the second visit , by the principal investigator , and with the presence of the team physician and preferably the patient " s family , for 20 - 30 minutes . The question about the physical activity of the patient and the family is to explore the condition of physical activity, weight and physical barriers, explain the importance and benefits of physical activity, disadvantages of non - mobility, types of exercises and exercises, as well as planning to consider the barriers to physical activity and provide a "safe and healthy life" to the patient. Early motivational follow - up two weeks after patient release from the hospital, phone calls to the patient can be increased by the researcher for an average of 10 minutes (as per the patient " s need).This call involves reviewing the feedback, reviewing the progress of the new incentive for change, reviewing behavioral changes (to increase physical activity and adherence to a healthy diet)and any positive change, an assessment of commitment to change behavior, monitoring the condition of eating and physical activity, motivating to return to the behaviors or lifestyle of prior unhealthy lifestyle and review of the training booklet. The second motivational follow - up of four weeks after the patient "s release from the hospital, the patient" s phone call can be eligible for an average of 10 minutes (as per the patient " s need). The content and purpose of this contact is similar to the first telephone follow - up . A third - week motivational follow - up week after patient release from the hospital, the patient "s phone call can be eligible for an average of 10 minutes (as per the patient" s need). the content and purpose of this call is similar to the first or second phone calls . " Changing a Woman for Healthy and Healthy Life " booklet aims to remind evocative interviews , foster healthy behaviors , as well as provide supplementary training . The contents of the booklet include : a simple explanation for the definition of cardiovascular risk factors , symptoms and effects of risk factors , risk factors of cardiovascular risk , metabolic inequalities , and their relevance to cardiovascular health , risk reduction in women and eating disorders , introducing well - known Iranian women with healthy lifestyles , healthy eating and physical activity .
Category
Behavior
2
Description
Control group:The control group in the emergency department receive regular emergency care and receive a routine training exercise on the patient " s illness on the day of their routine training and on patient requests . In order to observe the ethical principles , it will be sent to the post - mail address to control the manual after the intervention is over .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahimi hospital
Full name of responsible person
Zahra Bazgir
Street address
Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
6814717361
Phone
+98 66 3340 7189
Email
zahrabazgir70@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Madani hospital
Full name of responsible person
Zahra Bazgir
Street address
Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
6814717361
Phone
+98 66 3340 7189
Email
zahrabazgir70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morovat Taheri Kalani
Street address
Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
6814717361
Phone
+98 66 3340 7189
Email
zahrabazgir70@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
1
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Bazgir
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
6814717361
Phone
+98 66 3340 7189
Email
zahrabazgir70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Integrated Lorestan Medical, Opposite to the Kahrizak Village, km 5 Road of Khorram Abad ,Boroujerd
City
khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 912 509 1279
Email
gholami.m@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Bazgir
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
6814717361
Phone
33407189
Email
zahrabazgir70@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