Protocol summary

Summary
In a randomized clinical trial study, the effect of physical activity group counseling on blood glucose and pregnancy outcomes in women with gestational diabetes will be studied based on the theory of planned behavior in 2015. Research environment includes Endocrinology and Metabolic Research Center of Zanjan hospital ,research population consists of women with gestational diabetes are referred to the center. intervention include 6 sessions of group counseling with the frequency of three times a week and each session will be for 50 to 60 minutes. It will be done after approving the diagnosis of gestational diabetes in pregnant women who have inclusion criteria and before uesing insulin ( according to the protocol country of Iran).If they have the restriction or prohibition of physical activity or sport side effects, and the loss of any of the criteria will be excluded. Content of consultation will be the relation to the activities of the four areas of activity in the house, traveling in the form of the walking , sport and business activities . based on theory of planned behavior (behavioral intention attitude to the subjective norms and perceived control) . Sample size estimate 80 persons . the follow-up will be done six weeks by diary, telephone . Primary outcomes included fasting plasma glucose,blood sugar two hours after eating, hemoglobin A1C- weight, the baby's height and head size. Apgar score at one and five minutes after birth, gestational age at birth, the baby's blood sugar one hour after birth, distress respiratory, neonatal injury at birth, hyperbilirubinemia 24 hours after delivery.-type delivery, induction of labor with oxytocin, during the first and second stages of labor,weight gain during the third trimester of pregnancy, systolic and diastolic blood pressure , number of hospitalizations, the satisfaction of physical activity, insulin is descriptive data collection will be a standard questionnaire of physical activity during pregnancy - questionnaire of physical activity based on theory-based physical activity and reports of Tested

General information

Acronym
Zanjan Diabetes Survey
IRCT registration information
IRCT registration number: IRCT2015073123423N1
Registration date: 2015-08-13, 1394/05/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-13, 1394/05/22
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Zanjan University of Medical Sciences; Endocrinology and Metabolic Diseases Research Center
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-20, 1394/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of physical activity group counseling on blood glucose and pregnancy outcomes in women with gestational diabetes; based on the theory of planned behavior
Public title
Effect of physical activity group counseling on blood glucose and pregnancy outcomes in women with gestational diabetes: based on the theory of planned behavior
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: healthy pregnant women with gestational diabetes at 26 to 30 weeks of pregnancy; consent to participate in the study; be resident in Zanjan city; no history or risk of premature labor, threatened abortion, incompetent cervix, multiple pregnancy, intrauterine growth retardation in recent pregnancy, chronic disease before and during pregnancy (known as pulmonary heart disease, seizures, and thrombophilia, pulmonary embolism, chronic hypertension, diabetes mellitus, hemoglobin less than 10 mg per deciliter ml). Exclusion criteria: if participants have restrictions or prohibition of physical activity or exercise side effects, and the loss of any of the criteria will be excluded.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Postal code
Approval date
2015-07-28, 1394/05/06
Ethics committee reference number
ZUMS.REC.1394.88

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
Fasting blood sugar
Timepoint
Before and 6 weeks after intervention
Method of measurement
Enzymatic glucose oxidase

2

Description
2 hours post prandial blood sugar
Timepoint
Before and 6 weeks after intervention/ daily
Method of measurement
Glucometer

3

Description
Hb A1c
Timepoint
Before and 6 weeks after intervention
Method of measurement
Kali Metric

Secondary outcomes

1

Description
Maternal outcome
Timepoint
24 hours after delivery
Method of measurement
Check list

2

Description
Neonatal Outcome
Timepoint
24 hours after delivery
Method of measurement
Check list

3

Description
Physical activity
Timepoint
Before and 2, 4 and 6 weeks after intervention
Method of measurement
Standard questionnaire of physical activity in pregnancy

Intervention groups

1

Description
The control group will receive only routine care including nutritional counseling and expert advice to regulate blood sugar.
Category
N/A

2

Description
According to the Protocol of our country, before insulin therapy in women with gestational diabetes advice regimen and physical activity is recommended for 2 weeks after diagnosing of diseases. In this study, the intervention will be done at this stage of the disease. Physical activity group counseling will be done at 6 meeting within two weeks. The content of counseling will be related to activities in four areas, activity in the house, the walk, exercised and business activities and based on theory of planned behavior (behavioral intention, attitude, subjective norm and perceived control) will be implemented. In counseling, participants better know their disease and self-care behaviors such as physical activity through conversations with advisers in an environment full of compromise. They learn how to make decisions, and finally find the solution to their problem. The combination of counseling with theories of health education can provide a clear framework for the guidance of the consultant's advice.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine and Metabolic Diseases Research Center
Full name of responsible person
Fatemeh Dousti
Street address
Endocrine and Metabolic Diseases Research Center, Vali Asr Square
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Soghrat Faghihzadeh
Street address
Zanjan University of Medical Sciencesو, Azadi Square
City
Zanajn
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
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
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Dousti
Position
MSc student in Consulting in Midwifery
Other areas of specialty/work
Street address
Endocrine and Metabolic Diseases Research Center, Vali Asr Square
City
Zanajn
Postal code
4515789589
Phone
+98 24 3377 2514
Fax
+98 24 3377 0305
Email
doustifotemat246@gmail.com
Web page address
nursing@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azam Maleki
Position
PhD student in midwifery
Other areas of specialty/work
Street address
Department of Midwifery, School of Nursing and Midwifery, Zanjan University of Medical Sciences
City
Zanjan
Postal code
4515789589
Phone
+98 24 3377 2513
Fax
+98 24 3377 0305
Email
malekia@zums.ac.ir
Web page address
nursing@zums.ac.ir

Person responsible for updating data

Contact

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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