application of HAPA model on the level of physical activity of patients with type 2 diabetes
Design
Clinical trials with control group, with parallel groups, stratified randomization, were performed on 109 patients with diabetes (55 interventions and 54 controls),Without blinding, Follow up after three months
Settings and conduct
The samples were selected from Diabetes Clinic (Endocrine and Domestic) located in Valiasr Hospital, Zanjan.
Four 60-90 minutes training sessions were conducted for the intervention group in a classroom located in Valiasr Hospital. How to intervene using lecture methods, group discussion, question and answer, and providing written instructional materials.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with type 2 diabetes (at least 1 year).
Have HbA1c above 7
have enough motivation to change the behavior.
Being able to participate and communicate.
Exclusion criteria:Not participating in another clinical trial.
Not having acute and long-term complications of diabetes preventing their physical activity
Not having mental disease
Do not use insulin
Intervention groups
The intervention group includes patients with type 2 diabetes receiving educational intervention based on the theory of HAPA.
The control group includes patients with type 2 diabetes receiving routine care.
Main outcome variables
Physical activity; HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181129041793N1
Registration date:2019-07-15, 1398/04/24
Registration timing:retrospective
Last update:2019-07-15, 1398/04/24
Update count:0
Registration date
2019-07-15, 1398/04/24
Registrant information
Name
Maedeh Ghobadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 5581
Email address
m.namadian@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-22, 1396/04/31
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2017-07-22, 1396/04/31
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
2017-12-09, 1396/09/18
Scientific title
Application of the Health Action Process Approach (HAPA) Theory, on physical activity in patients with type 2 diabetes
Public title
Application of (HAPA) Theory, on physical activity in Diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
patients with type 2 diabetes (at least 1 year).
Have HbA1c above 7
have enough motivation to change the behavior.
Being able to participate and communicate.
Not participating in another clinical trial.
Exclusion criteria:
Not having acute and long-term complications of diabetes preventing their physical activity
Not having mental disease
Do not use insulin
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
109
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the eligible individuals, the subjects were grouped according to age and sex and selected according to the ratio of each group among the groups (in the number of samples) (randomized sampling) and with The simple randomized method (using nuts) was divided into intervention and control groups
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 Zanjan University of Medical Sciences
Street address
Headquarters of Zanjan University of Medical Sciences, Beginning of Islamic Republic Boulevard, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
1998893697
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
ZUMS.REC.1396.04
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
IV
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
physical activity Walking
Timepoint
Before intervention - three months after the end of the intervention
Method of measurement
IPAQ questionnaire - HAPA questionnaire - Measure the number of steps with a pedometer
Secondary outcomes
1
Description
HbA1c levels
Timepoint
Before the intervention - three months after the intervention
Method of measurement
HbA1c measuring device (Nicokard)
Intervention groups
1
Description
Intervention group: The intervention group was received a theory-based four educational sessions (lasted 60-90 minutes) according to the HAPA model constructs (self-efficacy, risk perception, outcomes expectation , Action Plan), and a physical activity programme.
Category
Lifestyle
2
Description
Control group: The control group was received a educational leaflet on diabetes and physical activity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Social Determinants of Health Reserach Center
Full name of responsible person
Dr. Masoumeh Namadian
Street address
Hospital of Valiasr Hospital, above Valiasr Square
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Fax
+98 24 3377 0757
Email
zsdhrc@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=9
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. َAlireza Shoghli
Street address
Reserach Deputy of Zanjan University of Medical Sciences, Beginning of Islamic Republic Boulevard, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
1998893697
Phone
+98 24 3342 0651
Email
info@zums.ac.ir
Web page address
http://zums.ac.ir/content/10256
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Masoumeh namadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Community Health
Street address
Zanjan Social determinants of Health research center, Vali-Asr Hospital
City
Zanjan
Province
Zanjan
Postal code
1998893697
Phone
+98 24 3377 0759
Email
m.namadian@zums.ac.ir
Web page address
http://zums.ac.ir/content/10256/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Masoumeh Namadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Determinants of Health Research Centre, Vali-asr Hospital, Zanjan University of Medical Sciences, Zanjan, Iran,
City
Zanjan
Province
Zanjan
Postal code
77978-45157
Phone
+98 24 3377 0759
Fax
+98 24 3377 0815
Email
m.namadian@zums.ac.ir
Web page address
http://zums.ac.ir/content/10256/
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Masoumeh Namadian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Community Health
Street address
Social Determinants of Health Research Centre, Vali-asr Hospital, Zanjan University of Medical Sciences, Zanjan, Iran,
City
Zanjan
Province
Zanjan
Postal code
77978-45157
Phone
+98 24 3377 0759
Fax
+98 24 3377 0815
Email
m.namadian@zums.ac.ir
Web page address
http://zums.ac.ir/content/10256
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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the participants information, including demographic characteristics and disease information after making anonymous of private information, methodology and results will be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researche team
Under which criteria data/document could be used
Observe the principles of trustee and insert the name of the researcher in the articles used in this research.
From where data/document is obtainable
Central Library of Zanjan University of Medical Sciences
What processes are involved for a request to access data/document
Send an email to the researcher
Comments
This project is A master student thesis, and if accepted in journals, its results will be published in the form of a paper