Protocol summary

Summary
Introduction: Diabetes is a chronic disease that its prevalence is increasing in the worldwide. The history of gestational diabetes is one of the major risk factors for getting diabetes type 2. The training methods that already have been used in the prevention of type 2 diabetes in the postpartum period could not be effective in all aspects of behavior. Thus, the present study examined the impact of multiple teaching methods on preventive behaviors of type 2 diabetes on postpartum in gestational diabetic women was performed. Objectives:1 - Comparison of a healthy diet at baseline, 2 and 6 weeks after delivery of the training and control groups 2-Comparison of physical activity at baseline, 2 and 6 weeks after delivery, training and control groups 3-Comparison of weight change 6 weeks after delivery to 2 weeks of training and control groups Design:This clinical trial is a two-group that was performed on 83 cases of women with gestational diabetes that referred to the selected health centers in Mashhad by multistage sampling. Major inclusion criteria: GA:28-36 week; Iranian and residing in Mashhad; GTT abnormal Major exclusion criteria: Risk of impaired glucose tolerance or diabetes mellitus before week 24 of pregnancy; Substance abuse and alcoholism; Speech and hearing problems; History of acute or chronic medical disease. Main outcome variables:Preventive behavior of type 2 diabetes in this study includes a healthy diet, physical activity and weight loss. Setting and conduct: The used scales are researcher-made questionnaires on diet and physical activity, practice check list and the recorded patient weight list. This method is that pregnant women with gestational diabetes at 36-28 weeks were randomly assigned to two training groups (n = 42) and controls (n = 41) and pre-test data were collected from both groups.finally in the second and third visits to postpartum care, two groups have completed the questionnaire again and changes in behavior were studied.Body weights were recorded in the second and third visiting on postpartum cares. Intervention:Teaching intervention over two sessions during 2 consecutive weeks by using lecture, group discussion, questions and answers, user training and follow-up phone calls were conducted .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121311744N1
Registration date: 2013-01-02, 1391/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-02, 1391/10/13
Registrant information
Name
Zahra Hesarinejad
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
hesarinz881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2012-11-16, 1391/08/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of multiple teaching methods to preventive behavior of postpartum Type2 Diabetes in gestational diabetic women attendance to Mashhad health centers
Public title
Effect of teaching on prevention of type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Major inclusion criteria: GA:28-36 week; Iranian and residing in Mashhad; GTT abnormal Major exclusion criteria: Risk of impaired glucose tolerance or diabetes mellitus before week 24 of pregnancy; Substance abuse and alcoholism; Speech and hearing problems; History of acute or chronic medical disease.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Building Qureshi, University Street, Mashhad
City
Mashhad
Postal code
۳۴۵ - ۹۱۳۷۵
Approval date
2012-05-11, 1391/02/22
Ethics committee reference number
511/0720

Health conditions studied

1

Description of health condition studied
gestational diabetes
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy

Primary outcomes

1

Description
Diet
Timepoint
Before training, two weeks and six weeks after delivery
Method of measurement
Questionnaire

2

Description
Weight
Timepoint
two weeks and six weeks after delivery
Method of measurement
Digital Scales

3

Description
Physical Activity
Timepoint
Before training, two weeks and six weeks after delivery
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Trainig group: Teaching intervention over two sessions during 2 consecutive weeks by using lecture, group discussion, questions and answers, user training and follow-up phone calls were conducted.
Category
Prevention

2

Description
Control group: During the study, the control group received no training by the researcher and the trained health centers were common.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rezashahr Health Center
Full name of responsible person
Mrs. Tohidi
Street address
Khaghani 10, Rezashahr
City
Mashhad

2

Recruitment center
Name of recruitment center
Daneshamouz Health Center
Full name of responsible person
Dr Zamani
Street address
Farhang sq, Daneshamouz 10, Daneshamouz blv, Vakilabad blv.
City
Mashhad

3

Recruitment center
Name of recruitment center
Shahid Saffari Health Center
Full name of responsible person
Mrs Lashgari
Street address
Piroozi 44, Piroozi blv.
City
Mashhad

4

Recruitment center
Name of recruitment center
Emamat Health Center
Full name of responsible person
Dr Shabahang
Street address
Emamat 28, Emamat blv, Azadshahr
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Department of Pharmaceutics, College of Pharmacy, Campus,Vakil abad blv, Mashhad
City
Mashhad
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 Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hesarinejad
Position
Master of Midwifery students
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doktora intersection
City
Mashhad
Postal code
Phone
+98 51 1841 1538
Fax
Email
hesarinz881@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nastaran Razmjoo
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doktora intersection
City
Mashhad
Postal code
Phone
+98 51 1841 1538
Fax
Email
razmjoon@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hesarinejad
Position
Master of Midwifery students
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doktora intersection
City
Mashhad
Postal code
Phone
00
Fax
Email
hesarinz881@mums.ac.ir
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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