Determining the effect of energy conservation techniques on fatigue, disordered eating behaviors and self-management in people with type 2 diabetes.
Design
The study will be a clinical trial with a control group. The study is double-blind and has a sample size of 56 people. The samples are selected according to the available method and assigned to the intervention or control group in a block method.
Settings and conduct
This double-blind study will be conducted in Arak University of Medical Sciences without informing the participants and the outcome evaluators of the groups. Training of the desired techniques for the intervention group will be considered for 3 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. Patients with type 2 diabetes (at least 3 to 6 months have passed since the definitive diagnosis of type 2 diabetes)
2. Age range from 20 to 70 years
3. Ability to implement energy conservation techniques
4. Speaking in Persian
5. Having hearing and sight
6. Not suffering from mental illnesses or using psychoactive drugs
7. Willingness to participate in the study
1. Unwillingness to participate in the study
2. Passing energy conservation courses
Intervention groups
Training of energy conservation techniques for the intervention group will be considered for 3 days (one day in between one session) and 2 hours every day, patients will use these techniques in their daily activities for 6 weeks. The control group will receive routine treatment.
The effect of energy conservation techniques on fatigue, eating disorder behaviors and self-management in people with type 2 diabetes
Public title
The effect of energy conservation techniques on people with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes (at least 3 to 6 months have passed since the definitive diagnosis of type 2 diabetes)
Age range from 20 to 70 years
Ability to implement energy conservation techniques(with the researcher's diagnosis)
Speaking in Persian
Having hearing and sight
Not suffering from mental illnesses or using psychoactive drugs
Willingness to participate in the study
Exclusion criteria:
Taking energy conservation courses
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by available method, and if the research samples are eligible to participate in the study, they will be placed in one of the test or control groups by random blocks of four (A, A, B, B). Code A will be assigned to the intervention group and code B will be assigned to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the researcher will perform the intervention and another colleague will collect the data, and also considering that the person who will also perform the data analysis will not know about the codes assigned to the patient, this study A double-blind face will be accepted.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-09-12, 1401/06/21
Ethics committee reference number
IR.ARAKMU.REC.1401.142
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
fatigue
Timepoint
before the start of the study and six weeks after the end of the intervention
before the start of the study and six weeks after the end of the intervention
Method of measurement
Diabetes Self-Management Questionnaire
3
Description
Eating disorder behaviors
Timepoint
before the start of the study and six weeks after the end of the intervention
Method of measurement
Eating disorder diagnosis scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The training of energy conservation techniques for the intervention group will be considered for 3 days (one day in between one session) and 2 hours every day, the patients will use these techniques in their daily activities for 6 weeks.
Category
Lifestyle
2
Description
Control group: The control group will receive routine treatment.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Waliasr Arak educational and therapeutic center
Full name of responsible person
Mahtab Farahani
Street address
Hazrat Waliasr Education and Treatment Center., Hazrat Valiasr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
Email
pr_valieasr@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/valiasrhos/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahtab Farahani
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
info@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Kobra Rahzani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
k.rahzani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahtab Farahani
Position
University student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
mahtabfarahanie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahtab Farahani
Position
University student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
mahtabfarahanie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The results will be made available to the public in the form of an article.