Protocol summary

Summary
The objective of the study is to determine the effect of Motivational Interviewing- based intervention through Self- determination theory on physical activity promotion and maintenance among women in fertility age who reffered to Health-care centers in Tonekabon. Inclusion Criteria is women 49-15 years, married, regular participation in educational sessions. Exclusion Criteria is pregnant women, with major diseases and orthopedic problems, irregular participation in educational sessions. This study carries out in two parts of Cross-sectional and Randomized controlled Trial. In the first part 412 women in fertility age who reffered to Health-care centers in Tonekabon that they are selected by randomized sampling and assessed. Data are collected by a questionnaire including demographic variables ,exercise history, anthropometric variables including Body Mass Index, physical fitness tests, a questionnaire including component of Self-determination theory and Global Physical Activity Questionnaire. In the second part of the study, among under-study subjects Cross-Sectionally, 70 women are randomly selected and participated in Randomized control Trial. The intervention group (N= 35) receive four group Motivational Interviewing sessions and one session of standard educational programme on physical activity. Control group (N=35) receive only one session of standard educational programme on physical activity. Randomized controlled Trial is carries out at before, immediately & 4-months after Educational program. early outcome of the intervention is its effect on component of self-determination theory and physical activity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101924592N1
Registration date: 2016-02-02, 1394/11/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-02, 1394/11/13
Registrant information
Name
Nooshin Rouhanitonekaboni
Name of organization / entity
Yazd Shahid Sadooghi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9138
Email address
mazloomy@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University Of Medical Sciences,School of Public Health
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-02-24, 1393/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Motivational Interviewing- based intervention through Self-Determination Theory on Physical Activity promotion and maintenance among women of fertile age who reffered to Health-care centers in Tonekabon
Public title
The effect of Motivational Interviewing- based intervention through Self-Determination Theory on Physical Activity promotion and maintenance among women of fertile age who reffered to Health-care centers in Tonekabon
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: women of 49-15 years; married; they were willing to participation to educational session; exclusion criteria: women were pregnant and they have major diseases and orthopedic problems; and they do not adhere intervention program.
Age
From 79 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
N/A
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
Yazd Shahid Sadooghi University of Medical Sciences
Street address
BahonarSquare, Yazd
City
Yazd
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
پ/17/1/165422

Health conditions studied

1

Description of health condition studied
Lack of Physical Activity
ICD-10 code
Z72.3
ICD-10 code description
Lack of physical exercise

Primary outcomes

1

Description
Physical Activity
Timepoint
Baseline and fourth month
Method of measurement
Global Physical Activity Questionnaire and Physical Fitness Tests

Secondary outcomes

1

Description
physical fitness tests
Timepoint
pretest-post test-follow up
Method of measurement
tests

Intervention groups

1

Description
Control group receive one session of standard educational programme on physical activity
Category
Behavior

2

Description
The intervention group receive Educational program included four group Motivational Interviewing sessions and one session of standard educational programme on physical activity
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Urban Health Care Centres
Full name of responsible person
Nooshin Rouhanitonekaboni
Street address
Urban Health Care Centres, Tonekabom, Mazandaran
City
Tonekabon

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd School of Public Health
Full name of responsible person
Dr Seyed Saeed Mazloomy Mahmoodabad
Street address
School of Public Health, Shohadaye Gomnam Blvd, Alem Square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd School of Public Health
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
Yazd Shahid Sadooghi University of Medical Sciences
Full name of responsible person
Nooshin Rouhanitonekaboni
Position
PhD Candidate
Other areas of specialty/work
Street address
School of Public Health, Shohadaye Gomnam Blvd, Alem Square, Yazd
City
Yazd
Postal code
Phone
+98 35 3820 9100
Fax
Email
rouhani.phd@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Shahid Sadooghi University of Medical Sciences
Full name of responsible person
Dr Seyed Saeed Mazloomy Mahmoodabad
Position
Professor
Other areas of specialty/work
Street address
School of Public Health, Shohadaye Gomnam Blvd, Alem Square, Yazd
City
Yazd
Postal code
Phone
+98 35 3820 9114
Fax
Email
mazloomy@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Phd Candidate, Department of Health Sevices of Yazd Shahid Sadooghi University of Medical Sciences
Full name of responsible person
Nooshin Rouhanitonekaboni
Position
PhD Candidate
Other areas of specialty/work
Street address
School of Public Health, Shohadaye Gomnam Blvd, Alem Suare, Yazd
City
Yazd
Postal code
Phone
+98 35 3820 9114
Fax
Email
rouhani.phd@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
Loading...