Protocol summary

Summary
This was an experimental single-blind randomized controlled trial (RCT) to determine comparative effectiveness of group therapy Beck cognitive interventions and motivational interviewing on reduction of overweight, glycemic and lipids control and quality of life in overweight and obese women with type 2 diabetes the effect of referring to Yazd Diabetes Research Center. Forty patients who meet the inclusion criteria (having BMI≥25, aged 18 to 65 years, female gender, diabetes, HbA1C≥7, the minimum cycle level of education, the signing of moral consent to participate in research) and exclusion criteria (the risk of psychiatric disorders such as eating disorders , personality disorder, bipolar disorder, obsessive-compulsive disorder on interview and according to the criteria of DSM-V, under psychiatric treatment or psychotherapy, having a program of moderate exercise at least 20 minutes a day, three days a week regularly for weight loss in the past six months based on self-reported, weight loss diet under the supervision of specialists in the past six months based on self-reported, debilitating diseases, diabetic complications such as advanced retinopathy and nephropathy. Also mutilation, drugs affecting the metabolism or weight body examination by a general practitioner and individual reports) are selected and put into two groups randomly (each group consisted of 20 patients). The intervention groups in addition their usual medication or diet therapy gets 8 sessions of group therapy cognitive intervention or motivational interviewing. In each group, before and after intervention also, four months after intervention the ORWELL and quality of life questionnaires will complete and blood samples will be compared to those of the patients themselves, or to the other group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017022132698N1
Registration date: 2017-04-08, 1396/01/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-08, 1396/01/19
Registrant information
Name
Raihane Azizi
Name of organization / entity
University of Medical Science of Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35372802215
Email address
r.azizi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of group therapy Beck cognitive interventions and motivational interviewing on reduction of overweight, glycemic and lipids control and quality of life in overweight and obese women with type 2 diabetes
Public title
Comparative Effectiveness of group therapy Beck cognitive interventions and motivational interviewing in overweight and obese women with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having BMI≥25; aged 18 to 65 years; female gender; diabetes; HbA1C≥7; the minimum cycle level of education; the signing of moral consent to participate in research. Exclusion criteria: The risk of psychiatric disorders such as eating disorders; personality disorder; bipolar disorder; obsessive-compulsive disorder on interview and according to the criteria of DSM-V; under psychiatric treatment or psychotherapy; having a program of moderate exercise at least 20 minutes a day; three days a week regularly for weight loss in the past six months based on self-reported; weight loss diet under the supervision of specialists in the past six months based on self-reported, debilitating diseases, diabetic complications such as advanced retinopathy and nephropathy; mutilation; drugs affecting the metabolism or weight body examination by a general practitioner and individual reports
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Yazd University of Medical Sciences
Street address
Bahonar square, Yazd, Iran
City
Yazd
Postal code
8917693571
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.SSU.REC.1395.205

Health conditions studied

1

Description of health condition studied
Type 2 diabete
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
hemoglobin A1c (HbA1c)
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
blood test

2

Description
BMI
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
blood test

3

Description
Triglisirid
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
blood test

4

Description
Total Cholestrol
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
blood test

5

Description
HDL
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
blood test

6

Description
LDL
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
blood test

Secondary outcomes

1

Description
Quality of life
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
questionnaire

2

Description
Obesity-Related WELL-being
Timepoint
Before the intervention, After intervention, 4 months after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
The intervention groups in addition their usual medication or diet therapy gets 8 sessions of group therapy cognitive intervention.
Category
Behavior

2

Description
The intervention groups in addition their usual medication or diet therapy gets 8 sessions of group therapy motivational interviewing.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabete Research Center
Full name of responsible person
Masoud Rahmanian
Street address
Talar Honar alley, Bahonar square, Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd Azad University
Full name of responsible person
Farzad Farhoodi
Position
PhD
Other areas of specialty/work
Street address
Daneshgah Boolvar, Yazd, Iran
City
Yazd
Postal code
Phone
00
Fax
Email
farzad_farhoodi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Diabete Research Center
Full name of responsible person
Raihane Azizi
Position
Endocorinologist, Assistant Professor
Other areas of specialty/work
Street address
Talare Honar Alley, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
Email
raihane.azizi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Diabete Research Center
Full name of responsible person
Frariba Sepehri
Position
MA Clinical Psychology. Researcher and Psychologist
Other areas of specialty/work
Street address
Talare Honar Alley, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
Email
sepehri_f66@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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