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The Effect of Self- management based on 5 A's Behaviour change model on appropriate gestational weight gain in overweight women reffered to Health care Centers

Protocol summary

Summary
This study aimed to determine the effect of self-management intervention model based on weight gain of 5 A perfect pregnancy overweight pregnant women referred to health centers of Urmia in 1394 will be carried out.This study is a quasi-experimental study with a control group. In this study, 8-6 Health Center with similar socio-economic conditions in three levels 1, 2 and 3 will be randomly selected.A total of 120 patients (60 cases and 60 cases in the control group) will be enrolled.After selecting the samples, the researchers also presented a briefing to the mothers, explained the purpose of the study and informed consent will be obtained from the samples.The demographic questionnaire, assessment of BMI and nutrition and physical activity assessment questionnaire, will be completed.Inclusion criteria include: consent for inclusion,overweight pregnant women 25≤BMI, singleton pregnancy, gestational age 6 weeks and higher, no history of underlying disease and criteria.Exclusion criteria were: current of any fault or condition in pregnancy, such as preeclampsia, diabetes, anemia, a high-risk pregnancy, multiple pregnancy,30≤BMI, the warning signs to avoid physical activity. The control group will receive usual care during pregnancy.But the intervention group after the intervention(Application nutrition and physical activity) based on the check list Model 5 A after 3 months via questionnaire FFQ, physical activity PPAQ pregnancy weight gain chart also be examined.The consequence of this study, appropriate weight gain during pregnancy among pregnant women will be overweight.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021224340N9
Registration date: 2016-05-30, 1395/03/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Hamideh Mohaddesi
Name of organization / entity
Urmia University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4963
Email address
mohaddesi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Orumieh University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Self- management based on 5 A's Behaviour change model on appropriate gestational weight gain in overweight women reffered to Health care Centers
Public title
The effect of self-management programs on proper pregnancy weight gain in overweight pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include: consent for inclusion Iranian compliance and resident of the city of Orumiyeh,at least literate, fluent in Farsi, access to telephones,18 years and older,overweight pregnant women 25≤BMI, singleton pregnancy, gestational age 6 weeks and higher, no history of underlying disease (diabetes, hypertension, kidney disease) or taking certain medications,lack of any history of mental illness and hospitalization (according to the client), no history of infertility, cervical incompetence, ectopic pregnancy, no previous pregnancy (miscarriage, bleeding, placenta previa), and having regular prenatal care . Exclusion criteria were: current of any fault or condition in pregnancy, such as preeclampsia, diabetes, anemia, a high-risk pregnancy, multiple pregnancy,30≤BMI, the warning signs to avoid physical activity: vaginal bleeding, dizziness, headache, chest pain, muscle weakness,pain or swelling of the leg (thrombophlebitis rejected), premature contractions, decreased fetal movement, amniotic fluid leakage, a special diet for disease, referring the patient to a specialist if weight gain is less than the amount envisaged in the Protocol country, the absence of training sessions, moved from Urmia, not wanting to participate in the study.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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 Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran (Postal Code:571478334)
City
Urmia
Postal code
5714783734
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Umsu.Rec.1394.322

Health conditions studied

1

Description of health condition studied
overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
appropriate gestational weight gain
Timepoint
before entervention,three Month after intervention
Method of measurement
FFQ, PPAQ

Secondary outcomes

empty

Intervention groups

1

Description
Self-management intervention model based on 5A (Ask, Assess, Advise, Agree, Assist and follow-up):Holding two one-hour individual sessions and run the first four of the five A (questions, assess, advise, agree).Within a week of individual instruction, for the fifth stage (assistance and follow-up), a group meeting in groups 8_10people will take place and then track the performance of pregnant women for 3 months (phone call, every 4 weeks for a meeting in person, check book self-reporting, evaluation weight).
Category
Behavior

2

Description
The control group receiving prenatal care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health care Centers in Urmia
Full name of responsible person
Narmin Ghaderpanah
Street address
St. Babasay،St.Shohada، Health Center Shohada
City
urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Orumieh University of Medical Sciences
Full name of responsible person
Dr.Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran (Postal Code:571478334)
City
Urmia
Grant name
-
Grant code / Reference number
1840
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Orumieh 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
Urmia Medical Science University
Full name of responsible person
Narmin Ghaderpanah
Position
Master Student of Midwifery Counseling
Other areas of specialty/work
Street address
Urmia Medical Science University Nursing & Midwifery Faculty Urmia
City
Urmia
Postal code
5714783734
Phone
+98 44 3275 4963
Fax
+98 44 3275 4921
Email
nghaderpanah5@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia Medical Science University
Full name of responsible person
Hamideh Mohaddesi
Position
Master Educated of Midwifery,Science Committee Member ofNursing & Midwifery Faculty,Urmia Medical Sc
Other areas of specialty/work
Street address
Urmia Medical Science University,Nursing & Midwifery Faculty
City
Urmia
Postal code
5714783734
Phone
+98 44 3275 4963
Fax
+98 44 3275 4921
Email
hmohaddesi.han@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia Medical Science University
Full name of responsible person
Narmin Ghaderpanah
Position
Master Student of Midwifery Counseling
Other areas of specialty/work
Street address
Street Bakeri alley Nikfarjam No. 253
City
Urmia
Postal code
5713694747
Phone
+98 44 3224 7281
Fax
Email
nghaderpanah5@gmail.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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