Effect of an intervention, based on Health Action Process Approach, on obesity surgery outcomes in patients undergone bariatric surgery after one year
Design
The study had a control group, with parallel groups, arranged in blocks on 90 patients
Settings and conduct
It was in Tehran Obesity Treatment Cohort Center that the educational intervention was done virtually and the control group received routine care in the center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent and one year after bariatric surgery
Non-entry conditions: Participant's pregnancy
Intervention groups
Educational interventions aimed at influencing the results of bariatric surgery were carried out on the intervention group using the structures of the health action process approach in the form of lectures, slide shows, sending pamphlets, sending educational and motivational text messages, and the control group received the usual care at the center.
Main outcome variables
Structures of the health action process model for self-management of appropriate diet, physical activity, self-management, blood chemistry parameters, food recall questionnaire, international physical activity questionnaire, BMI, body weight loss percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230722058887N1
Registration date:2023-08-21, 1402/05/30
Registration timing:prospective
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Maryam Maghsoodlo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3230 2275
Email address
maryam.maghsoodlo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-16, 1402/06/25
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an intervention, based on Health Action Process Approach, on obesity surgery outcomes in patients undergone bariatric surgery after one year
Public title
Comparison of intervention after bariatric surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
One year after surgery
Consent to participate
Exclusion criteria:
Pregnancy of participating women
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation: with a computer program, by randomizing alternative blocks with the length of random variable blocks of 2, 4 and 6 And the ratio is 1:1
Consecutive sampling method, 90 people are selected from the center and entered into the sample from among the people who had the conditions to enter the study and did not have the conditions to leave the study.
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Porsina Alley, Shanzdeh Azar St
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.TUMS.SPH.REC.1400.230
Health conditions studied
1
Description of health condition studied
Bariatric surgery patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-management
Timepoint
4 months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
reminder questionnaire
Timepoint
4 months
Method of measurement
questionnaire
2
Description
Healthy diet with health action process approach model constructs
Timepoint
4 months
Method of measurement
questionnaire
3
Description
Physical activity with the structures of the health action process approach model
Timepoint
4 months
Method of measurement
questionnaire
4
Description
International Physical Activity Questionnaire
Timepoint
4 months
Method of measurement
questionnaire
5
Description
Bariatric surgery self-management behaviors
Timepoint
4 months
Method of measurement
questionnaire
6
Description
Blood chemical parameters Fe
Timepoint
4 months
Method of measurement
Hitachi autoanalyzer
7
Description
Hemoglobin blood chemical parameters
Timepoint
4 months
Method of measurement
Hitachi autoanalyzer
8
Description
Hematocrit blood chemical parameters
Timepoint
4 months
Method of measurement
Cell counter machine
9
Description
BMI
Timepoint
4 months
Method of measurement
Calculate the weight divided by the square of the height
Intervention groups
1
Description
Intervention group: Intervention group: For only the intervention group, we sent a training class, pamphlets and educational SMS
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Obesity Treatment Cohort (Hakim Clinic) درمان چاقی تهران(کلینیک حکیم)
Full name of responsible person
Dr. Alireza Khalaj
Street address
Number 49, Manzar Nejad Alley, Shariati St
City
Tehran
Province
Tehran
Postal code
5133072100
Phone
+98 21 2664 4853
Email
khalaj.totc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoume Doreghi
Street address
Porsina Alley, Shanzheda Azar St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Fax
Email
sph@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
34
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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Maghsoodlo
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Porsina Alley, Shanzheda Azar St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 17 3230 2275
Email
maryam.maghsoodlo@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam maghsoodlo
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Porsina Alley, Shanzheda Azar St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 17 3230 2275
Email
maryam.maghsoodlo@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam maghsoodlo
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Porsina Alley, Shanzheda Azar St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 17 3230 2275
Email
maryam.maghsoodlo@gmail.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