the Effect of Self Determination Theory (SDT) based physical activity motivational intervention on happiness and quality of life: A randomized controlled trial
Objective: To evaluate the Effect of Self Determination Theory (SDT) based physical activity motivational intervention on happiness and quality of life: A randomized controlled trial. Design: A randomized controlled trial. Setting: 86 women aged 30-45 years, covered by damghan urban health centers. Inclusion criteria: female; Age between 30 to 45 years old; Body Mass Index (BMI)<35; Infertility; Not involving in a routine physical activity programs; Not having any wound and health problem (or being on medicine) which leads to any movement prohibition recommendation; They do not tend to move to another city. Exclusion criteria: Catching a severe illness (psychological or physical) with any medical diagnosis and drug treatment; Unwillingness of the individual to continue the cooperation; Not being able to continue due to the personal reasons. Intervention: At the first meeting, the participants will receive the learning materials and devices (forms and pedometer) with a manual about how to use and keep the pedometer also a training manual according to the educational topics of ministry of health and medical education, and they will be trained to work with pedometer. These people will participate in 8 hours of the designed sessions based on SDT protocol and motivational interviews about physical activity.
Control: At the first meeting, the learning materials and devices (forms and pedometer) with a manual about how to use and keep the pedometer also a training manual will be given to participants and they will be trained to work with pedometer. The individuals will participate in 8 hours learning sessions, based on the ministry of health and medical education topics about physical activity including a summary of physical conditions i.e. BMI, and they will receive a list of the learning programs - in process - in the health centers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020223072N1
Registration date:2017-01-13, 1395/10/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-13, 1395/10/24
Registrant information
Name
Mohammadreza Ghaneapur
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 88989128
Email address
mr-ghaneapur@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research and Technology, Tehran University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2017-01-09, 1395/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the Effect of Self Determination Theory (SDT) based physical activity motivational intervention on happiness and quality of life: A randomized controlled trial
Public title
the Effect of Self Determination Theory (SDT) based physical activity motivational intervention on happiness and quality of life: A randomized controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female; Age between 30 to 45 yeas old; Body Mass Index ( BMI )<35; Infertility; Not involving in a routine physical activity programs; Not having any wound and health problem (or being on medicine) which leads to any movement prohibition recommendation; They don't tend to move to another city.
Exclusion criteria: Catching a severe illness (psychological or physical) with any medical diagnosis and drug treatment ; not being able to continue due to the personal reasons.
Age
From 30 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
By using Firmware of Block Stratified Randomization Ver.6, allocation of samples Will be done in a manner of Randomized Block Desig n.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Tehran University of Medical Sciences, Pursina Avenue, Tehran, Iran, Islamic Republic Of
City
Tehran
Postal code
1417653761
Approval date
2015-10-27, 1394/08/05
Ethics committee reference number
IR.TUMS.REC.1394.1020
Health conditions studied
1
Description of health condition studied
Physical Activity
ICD-10 code
Z72.3
ICD-10 code description
Lack of physical exercise
Primary outcomes
1
Description
Physical Activity
Timepoint
Before the intervention, one month after the start of intervention and three months later
Method of measurement
Pedometer
Secondary outcomes
1
Description
Happiness
Timepoint
Before the intervention, one month after the start of intervention and three months later
Method of measurement
Oxford Happiness Inventory
2
Description
Quality of Life
Timepoint
Before the intervention, one month after the start of intervention and three months later
Method of measurement
SF-36 Questionaire
Intervention groups
1
Description
Intervention group: At the first meeting, the participants will receive the learning materials and devices (forms and pedometer) with a manual about how to use and keep the pedometer also a training manual according to the educational topics of ministry of health and medical education and they will be trained to work with pedometer. These people will participate in 8 hours of the designed sessions based on Self Determination Theory and motivational interviews about physical activity.
Category
Lifestyle
2
Description
Control group: At the first meeting, the learning materials and devices (forms and pedometer) with a manual about how to use and keep the pedometer also a training manual will be given to participants and they will be trained to work with pedometer. The individuals will participate in 8 hours in learning sessions, based on the ministry of health and medical education topics, about physical activity including a summary of physical conditions i.e. BMI and they will receive a list of the learning programs - in process - in the health centers.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Damghan Health Center
Full name of responsible person
Mohammad Reza Ghaneapur
Street address
Damghan Health Center, Fallahi Avenue, Damghan city, Semnan province, Islamic Republic of Iran
City
Damghan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Yunesian
Street address
Vice-chancellor of Research and Technology, Tehran University of Medical Sciences, Pursina street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research and Technology, Tehran 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
Tehran University of Medical Sciences, Department of Health Education and Promotion
Full name of responsible person
Dr. Hassan Eftkhar
Position
Pediatrician, MD, MPH/ Professor
Other areas of specialty/work
Street address
Department of Health Education and Promotion, Tehran University of Medical Sciences, Pursina street
City
Tehran
Postal code
1417613153
Phone
+98 21 8898 9128
Fax
+98 21 8898 9128
Email
eftkhara@sina.tums.ac.ir
Web page address
WWW.TUMS.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Department of Health Education and Promotion
Full name of responsible person
Dr.Hassan Eftkhar
Position
Pediatrician, MD, MPH/ Professor
Other areas of specialty/work
Street address
Department of Health Education and Promotion, Tehran University of Medical Sciences, Pursina street
City
Tehran
Postal code
1417613153
Phone
+98 21 8898 9128
Fax
+98 21 8898 9128
Email
eftkhara@tums.ac.ir
Web page address
www.TUMS.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghaneapur
Position
PhD Candidate of Health Education and Promotion
Other areas of specialty/work
Street address
Department of Health Education and Promotion, Tehran University of Medical Sciences, Pursina street
City
Tehran
Postal code
1417613153
Phone
+98 21 8898 9128
Fax
+98 21 8898 9128
Email
Ghaneapur48@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)