Study and comparison the effectiveness of family-centered empowerment, collaborative care model and motivational interviewing techniques on blood sugar control and eating behaviors based on BASNEF model among patients with diabetes
Studying the effectiveness of behavior change techniques on the sugar blood control and nutritional behaviors
Design
In this single blind randomized clinical trial, with parallel form, subjects in all four groups are randomly assigned into the study. Samples will be selected using the multistage cluster sampling. At first, among 80 health houses, we will consider 3 health houses and 60 subjects will be included in each health house (30 in the control group and 30 in the intervention group). Finally, 180 patients will be considered to participate in the study.
Settings and conduct
The statistical population will be patients with type 2 diabetes referred to the rural health centers in Gorgan. In this study, a multi-stage cluster sampling will be used. Patients will be blinded to the type of intervention they will receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with type 2 diabetes diagnosed by a physician; Patients who have been registered and have records in health houses
Intervention groups
There are four groups. Intervention group 1: Collaborative care including four steps in the form of two phases of collaborative educational visits and collaborative follow-up visits. Intervention group 2: Family-based empowerment consisting of four stages of perceived threat, self-efficacy, self-esteem and evaluation; Intervention group 3: Motivational interviewing including four principles of express empathy, develop discrepancy, rolling with resistance, self-efficacy support. The control group: receiving common training in the health centers about diabetes.
Main outcome variables
Blood glucose: Nutritional behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140518017736N10
Registration date:2018-12-05, 1397/09/14
Registration timing:registered_while_recruiting
Last update:2018-12-05, 1397/09/14
Update count:0
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Seyed Kamaladdin Mirkarimi
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 1553 2872
Email address
k.mirkarimi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study and comparison the effectiveness of family-centered empowerment, collaborative care model and motivational interviewing techniques on blood sugar control and eating behaviors based on BASNEF model among patients with diabetes
Public title
The effectiveness of family-centered empowerment, collaborative care model and motivational interviewing techniques on blood sugar control and eating behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes diagnosed by a physician
Patients who have been registered and have records in health houses in Gorgan
Not participating in other family-based empowerment training classes, collaborative care model and motivational interviewing
Reading and writing literacy
Exclusion criteria:
Consumption of medications which have possible interaction with type 2 diabetes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a multi-stage cluster sampling method will be used. At first, 80 Health Houses will be selected and then, three health houses will be selected using the simple sampling method. Randomization will be done using SPSS (version 18) software.
Blinding (investigator's opinion)
Single blinded
Blinding description
There is no blinding process at present study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
4th Kilometer of Gorgan-Sari Road
City
Gorgan
Province
Golestan
Postal code
4917818183
Approval date
2016-12-18, 1395/09/28
Ethics committee reference number
IR.GOUMS.REC.1395.211
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Blood sugar
Timepoint
Pre-intervention, 2, 6 and 12 months after intervention
Method of measurement
Fasting blood sugar test and HbA1C for measuring blood sugar
2
Description
Nutritional behaviors
Timepoint
Pre-intervention, 2, 6 and 12 months after intervention
Method of measurement
Standardized questionnaire of food frequency for measuring eating behaviors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Collaborative Care. It consists of four stages: 1) motivation, 2) preparation, 3) engagement and 4) evaluation. These four steps will be conducted in the form of two phases of collaborative educational visits and collaborative follow-up visits. Interventions for all visits will be conducted for 2 groups of 15 (30 in total) independently (each session duration is 60-45 minutes on average).
Category
Behavior
2
Description
Intervention group 2: Family-based Empowerment.It consists of four stages of perceived threat, self-efficacy, self-esteem and evaluation. All stages are delivered through two 30-45 minute sessions. Each group has 15 people (2 groups of 15).
Category
Behavior
3
Description
Intervention group 3: Motivational Interviewing. It consists of four basic principles: expressing empathy, developing discrepancy, rolling with resistance and self-efficacy support. Each group consists of 10 patients. The training will be delivered through 5 30-45 minute sessions.,
Category
Behavior
4
Description
Control group: This group only receives common training about diabetes in the health centers through 5 30-45 minute sessions. Each group has 15 patients (2 groups of 15)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Laboratories
Full name of responsible person
Alireza Dehghan
Street address
Laboratory Unit, 5 Azar Hospital, 5 Azar street, Gorgan city, Golestan Province
City
Gorgan
Province
Golestan
Postal code
4917848183
Phone
+98 17 3216 0330
Email
ak.mirkarimi@gmail.com
2
Recruitment center
Name of recruitment center
Health House
Full name of responsible person
Vahid Maghsoudloo
Street address
Amir Abad, Kafshgiri and Hashem Abad villages, Gorgan city
City
Gorgan
Province
Golestan
Postal code
4917848183
Phone
+98 17 3216 0330
Email
Maghsoudlo-v@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyyed Kamaladdin Mirkarmi
Street address
No 19, 2 Floor, Shaghayegh building, 3rd Sima Alley, 57 Valiasr Street
City
Gorgan
Province
Golestan
Postal code
4917848183
Phone
+98 17 3253 2872
Email
k.mirkarimi@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Seyyed Kamaladdin Mirkarimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Golestan University of Medical Sciences, 4th Kilometer of Gorgan-Sari Road
City
Gorgan
Province
Golestan
Postal code
4917848183
Phone
+98 17 3216 0330
Email
k.mirkarimi@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyyed Kamaladdin Mirkarimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Golestan University of Medical Sciences, 4th Kilometer of Gorgan-Sari Road
City
Gorgan
Province
Golestan
Postal code
4917848183
Phone
+98 17 3216 0330
Email
k.mirkarimi@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyyed Kamaladdin Mirkarimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Golestan University of Medical Sciences, 4th Kilometer of Gorgan-Sari Road
City
Gorgan
Province
Golestan
Postal code
4917848183
Phone
+98 17 3253 2872
Email
k.mirkarimi@goums.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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcomes of the study will provide for decision makers and authorities of Health Deputy
When the data will become available and for how long
The study will be conducted in November 1397 and results will be presented after one year
To whom data/document is available
All academic researchers will have access to the results
Under which criteria data/document could be used
In addition to publishing results in valid journals, the results will be available to officials working in the provincial health center
From where data/document is obtainable
Dr Seyyed Kamaladdin Mirkarimi, Assistant Professor, Department of Public Health, Golestan University of Medical Sciences, Mobile number 09112731646 and email k.mirkarimi@goums.ac.ir
What processes are involved for a request to access data/document
Results, questionnaire and study tools will be available to all researchers (after publication of the paper) through the telephone and email