Protocol summary

Summary
The aim of this study was to evaluate the impact of physical activity after childbirth has been done on anthropometric indices. In this randomized controlled trial, 70 women who had undergone a delivery during 6 weeks to 6 months prior to admission, aged 18-40 years old, primiparous, were enrolled and randomly assigned to receive a 3-month intervention to increase physical activity using pedometer, in intervention group the routine outpatient department obstetric educational program, in control group. Assessments of anthropometric measurements including body weight, body mass index, waist and hip circumferences, waist to hip ratio and physical activity were conducted before and after the intervention and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105026362N1
Registration date: 2011-07-21, 1390/04/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-21, 1390/04/30
Registrant information
Name
Masoumeh Sechin Mattori
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7543
Email address
mattori.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-03-19, 1389/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical activity on postpartum anthropometric measurements
Public title
Effect of physical activity on weight loss after delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18-40 years old, primiparous, singleton pregnancies, More than nine years of education, exclusive breast feeding Exclusion criteria: professional athletes (who plan exercise more than 30 minutes a day or five to seven days a week), medical and systemic diseases, Smoking or stop smoking during breast-feeding, Alcohol Addiction, lean and obese according to initial BMI before pregnancy (BMI ≤ 19 / 8, BMI ≥ 29 kg/m), preeclampsia, suffering musculoskeletal disorders (lumbar disc, osteoarthritis), cesarean delivery with complications
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: 70
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Vice chancellor for Research Office, Ahvaz Jondishapour University of Medical Sciences, University Campus, Ahvaz
City
Ahvaz
Postal code
15794-63157
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
U-89187

Health conditions studied

1

Description of health condition studied
postpartum obesity
ICD-10 code
E66.8
ICD-10 code description
Other obesity

Primary outcomes

1

Description
Weight
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
Scale

2

Description
Bady Mass Index
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
Scale and Centimeter

3

Description
Waist Circumference
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
Centimeter

4

Description
Hip Circumference
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
Centimeter

5

Description
Waist to Hip ratio
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
Centimeter

6

Description
Physical Activity
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
International Physical Activity Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Educational intervention aiming at increasing physical activity after delivery, using a pedometer for 3 months. 70 steps daily (500 steps weekly) were added During the 3 month intervention
Category
Lifestyle

2

Description
Control group: the routine outpatient department obstetric educational program in postpartum.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Abadan Health Centers
Full name of responsible person
Masoumeh Sechin Mattori
Street address
College of Nursing and Midwifery Islamic Azad University, Sikline, Abadan
City
Abadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Jondi Shapur Ahvaz University of Medical Sciences
Full name of responsible person
Mostafa Feghhi
Street address
Jondi Shapur Ahwaz University of Medical Sciences, opposite the central building, Vice Chancellor for Research, Ahwaz University of Medical Sciences, Ahvaz
City
Ahvaz
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, Jondi Shapur Ahvaz 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masoumeh Sechin Mattori
Position
Graduate student
Other areas of specialty/work
Street address
Ground Floor, Vice chancellor for Research Office, Ahvaz Jondishapour University of Medical Sciences, University Campus, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1333 3477
Fax
Email
mattori.m@ajums.ac.ir nastaran47@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Porandokht Afshari
Position
M.Sc,Member of Scientific Board in Nursing and Midwifery College
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, College of nursing and midwifery
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8394
Fax
Email
p_afshary@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masoumeh Sechin Mattori
Position
Graduate student
Other areas of specialty/work
Street address
Azad Abadan College Nursing and Midwifery-Siklin
City
Abadan
Postal code
Phone
+98 63 1222 5001
Fax
+98 63 1222 5001
Email
mattori.m@ajums.ac.ir nastaran47@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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