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Effectiveness of theory based education program with spouse's participation to promote lifestyle to

Protocol summary

Summary
This study is designed to evaluate effectiveness of theory based education program with spouse's participation to promote lifestyle for suitable weight gain in pregnancy. This clinical randomized control trial (single blind), will conduct on 150 pregnant women expecting their first child’s attending to one of hospital centers Located in Tehran. Pregnant women randomly assigns to three groups: Group A: pregnant women and their husbands will receive nutritional and exercise education together, Group B: pregnant women will receive diet and exercise education too and Group C: pregnant women will only receive routine prenatal care (control). Data will collect by completing questionnaires including: demographic characteristics, 24-hour dietary recall, food frequency questionnaire (FFQ), nutrition and exercise Knowledge questionnaire and some other questionnaires related to constructs of the Trans theoretical model (TTM). The inclusion criteria are completing a written consent; age >18 years; Knowing pre-pregnancy weight and single pregnancy. Exclusion criteria are diabetes; Contraindications for exercise and unintended pregnancy. After completing a written consent, in the intervention group A and B the intervention including (the Dietary pattern, importance and benefits, contraindications exercise and appropriate exercises during pregnancy). Education program will held in two sessions through lectures. Applying the ccomprehensive guide for nutrition during pregnancy based on TTM established by the Ministry of Health and Medical Education of Iran. Totally, weight gain in end of third trimester, exercises and nutrition Knowledge, dietary Patterns and constructs of TTM to nutrition will assess four weeks after the intervention, end of second and third trimester in three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102530496N1
Registration date: 2016-12-23, 1395/10/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
Azita Kiani Asiabar
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 4442 1331
Email address
a.kianiasiabar@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University, Research Assistance
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effectiveness of theory based education program with spouse's participation to promote lifestyle to
Public title
Effectiveness of education with spouse's participation to suitable weight gain in pregnancy.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria Sign up the project consent form; Age older than 18 years old; Knowing pre-pregnancy weight; Live fetus and Singleton; Nulliparous; Exclusion criteria: Any disorder which prevents the exercise; Diabetes before pregnancy; vegetarianism; unintended pregnancy;
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were randomly assigned to three groups: the first woman pregnant in group A, the second woman pregnant in group B and the third woman pregnant in control group assigned and will be repeated.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr bridge, Jalal Al-e Ahmad St.
City
Tehran
Postal code
111-14115
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
IR.TMU.REC.1394.40

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
XV
ICD-10 code description
Pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
gestational weight gain
Timepoint
Before intervention, a month after the intervention and end of second trimester and the end of the third trimester of pregnancy
Method of measurement
balance

Secondary outcomes

1

Description
Knowledge of exercises during pregnancy
Timepoint
efore intervention, a month after the intervention and end of second trimester and the end of the third trimester of pregnancy
Method of measurement
Research made questionnaire

2

Description
Dietary patterns
Timepoint
Before intervention, a month after the intervention and end of second trimester and the end of the third trimester of pregnancy
Method of measurement
questionnaire FFQ

3

Description
Awareness of Proper diet during pregnancy in pregnancy
Timepoint
Before intervention, a month after the intervention and end of second trimester and the end of the third trimester of pregnancy
Method of measurement
Research made questionnaire

4

Description
Self-efficacy and decisional balance Transtheoretical model in relation to food patterns during pregnancy
Timepoint
Before intervention, a month after the intervention and end of second trimester and the end of the third trimester of pregnancy
Method of measurement
Research made questionnaire

Intervention groups

1

Description
Intervention group1: Pregnant women and husband two sessions (90 minutes) once a week for two consecutive weeks received diet, gaining weight and physical activity education together.
Category
Lifestyle

2

Description
Intervention group 2: pregnant women received diet, gaining weight and physical activity education alone to two sessions (90 minutes) once a week for two consecutive weeks.
Category
Lifestyle

3

Description
control group: Pregnant women received routine prenatal care but but no advice on diet, gaining weight and physical activity.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Najmieh
Full name of responsible person
Azita kianiasiabar
Street address
The intersection of Hafez Ave, Republic Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University, Research Assistance
Full name of responsible person
Dr. Fathollahi Yaghoub
Street address
No. 7, Jalal Al Ahmad Street,
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University, Research Assistance
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
Tarbiat Modares University
Full name of responsible person
Azita Kiani Asiabar
Position
PhD student of Health Education and health promotion
Other areas of specialty/work
Street address
Tarbiat Modares University, Department of Health Education
City
Tehran
Postal code
Phone
+98 21 4442 1331
Fax
+98 21 6641 8590
Email
a.kianiasiabar@modares.ac.ir; kian_acia@yahoo.com; kiani@shahed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farkhondeh Amin Shokravi
Position
Health Education Ph.D
Other areas of specialty/work
Street address
Tarbiat Modares University, Department of Health Education
City
Tehran
Postal code
Phone
+98 21 8288 4506
Fax
Email
aminsh_f@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Azita Kiani Asiabar
Position
PhD student of Health Education and Health Promotion
Other areas of specialty/work
Street address
Tarbiat Modares University, Department of Health Education and Health Promotion
City
Tehran
Postal code
Phone
+98 21 4442 1331
Fax
Email
a.kianiasiabar@modares.ac.ir; kian_acia@yahoo.com; kiani@shahed.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
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Analytic Code
empty
Data Dictionary
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