Protocol summary

Summary
Forty six obese patients (BMI>=25) who come to obesity clinic of Rasool Akram hospital for first time since 2015 to 2016 will be included in this study. The object of this study is assessment of exercise prescription in weight loss and physical activity. They will be evaluated in anthropometric parameters (weight, height, BMI, waist circumferences, hip circumferences, thigh circumferences, body composition), physical activity score and motivation. they divide in two groups randomly; 1- exercise prescription orally and 2- exercise prescription orally plus 5 minutes telephone reminder a week. patients in each group take a exercise prescription according to basic level of fitness. They take a aerobic program with frequency 5 times a week, intensity 40-60 % of heart rate reserve, 20-30 minutes a day.They can progress their program in time (5 min each two weeks) and intensity (up to 60 % heart rate reserve). The researcher call the patients and remind them of exercise and activity that they should do. All of the patients will be followed three months later. All of the parameters have pointed above are the outcome that will be evaluated 3 months later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506234409N5
Registration date: 2015-07-24, 1394/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Parisa Nejati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 0361
Email address
parisanejati@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-07-01, 1394/04/10
Expected recruitment end date
2016-07-01, 1395/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectivness of orall exercise prescription and telephone reminder plus orall exercise prescription on physical activity in obese patients who refer to obesity clinic of Rasool Akram hospital during 1394.
Public title
Exercise prescription in physical activity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Overweight and obesity (BMI>=25); No exercise at least last three months; Absence of contraindication in aerobic exercise; Not using non-invasive weight loss methods during last 6 months; Not using bariatric surgery during last year; Exclusion criteria: The patients who do not like to continue; The patients who use other weight loss methos
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
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
Iran University of Medical Sciences
Street address
Next to Milad tower, Hemmat highway
City
Tehran
Postal code
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
94-01-30-25144-112373

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E65, E66.0
ICD-10 code description
Other obesity, Localized adiposity, Obesity due to excess calories, Obesity unspecified

Primary outcomes

1

Description
Physical activity score
Timepoint
Before intervention and three months after intervention
Method of measurement
International physical activity questionnaire (IPAQ)

2

Description
Anthropometric parameters (height, weight, waist circumference, hip circumference, thigh circumference)
Timepoint
Before intervention and three months after intervention
Method of measurement
Flexible ruler

3

Description
Body composition
Timepoint
Before intervention and three months after intervention
Method of measurement
Bio impedance analyser

Secondary outcomes

1

Description
Motivation
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Motivation questionnaire

Intervention groups

1

Description
Aerobic exercise prescription begins with walking program 5 times a week, 40 -60% heart rate reserve, 20-30 minutes a week. It will progress according to physical fitness.
Category
Lifestyle

2

Description
Aerobic exercise prescription begins with walking 5 times a week, 40 -60% heart rate reserve, 20-30 minutes a day plus 5 minutes a week reminder by telephone call.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Obesity clinic of Hazrate Rasool Akram hospital
Full name of responsible person
Parisa Nejati, Assistant professor of sports medicine
Street address
Sports medicine department, Eight floor, Rasool Akram hospital, Niyayesh street, Satarkhan street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Javad Moosavi
Street address
Next to Milad tower, hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Rasool Akram hospital
Full name of responsible person
Parisa Nejati
Position
Assisstant professor of sports medicine
Other areas of specialty/work
Street address
Sports medicine clinic, Rasool Akram hospital, Sattarkhan street
City
Tehran
Postal code
Phone
+98 982164352446
Fax
Email
parisanejati@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasool Akram hospital
Full name of responsible person
Parisa Nejati
Position
Sports medicine specialist
Other areas of specialty/work
Street address
Sports medicine clinic, Rasool Akram hospital, Satarkhan street
City
Tehran
Postal code
Phone
+98 219125955643
Fax
Email
parisanejati@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Assistant professor of sports medicine
Other areas of specialty/work
Street address
8th floor, Rasool Akram hospital, Satarkhan street
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
parisanejati@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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