1. Determine the effect of economic incentives on weight loss in the study population
2. Determine the effect of economic incentives on reducing BMI of the study subjects
3. Determine the effect of economic incentives on lowering blood lipid profiles (TG, LDL, HDL, Chol
Design
Clinical trial without control group, phase one, 103 patients sample size
Settings and conduct
Participants in this study were women referred to two health centers in slums area of Kermanshah who were randomly selected from the list of centers with over 30 women. The study site was Nutrition Faculty of Kermanshah University of Medical Sciences, which were visited for follow-up each month.
Participants/Inclusion and exclusion criteria
Obese women over 30 and all with low socioeconomic status; pregnant women, experienced unsuccessful attempt for weight reduction and serious to weight loss
Intervention groups
The intervention of this study was to pay financial incentives to all participants.
Diet and physical activity programs were also provided to everyone.
Main outcome variables
weight loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120525009856N8
Registration date:2020-02-25, 1398/12/06
Registration timing:retrospective
Last update:2020-02-25, 1398/12/06
Update count:0
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Yahya Pasdar
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 1991
Email address
yahya.pasdar@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
2017-12-11, 1396/09/20
Actual recruitment end date
2018-12-11, 1397/09/20
Trial completion date
2018-12-11, 1397/09/20
Scientific title
The Effect of economic motivation on weight reduction women in Kermanshah
Public title
Economic incentives and weight loss
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age over 30 years
obese women (BMI≥30 kg/m2)
Exclusion criteria:
pregnant women
People who have been following a special diet from last 6 months to lose weight
Age
From 30 years old to 53 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
103
Actual sample size reached:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences, Kermanshah, Iran
Street address
Deputy of Research and Technology, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
KUMS.REC.1394.484
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
weight
Timepoint
Month 1,2,3,4,5,6,12
Method of measurement
in term of kg, by using body analyzer instrumen
2
Description
body mass index
Timepoint
Month 1,2,3,4,5,6,12
Method of measurement
in term of kg/m2, by using body analyzer instrumen
Secondary outcomes
1
Description
serum Total triglycerides
Timepoint
Month 1,3,6
Method of measurement
by using biochemical kits (Monobind ELISA kit)
2
Description
Serum LDL
Timepoint
Month 1,3,6
Method of measurement
by using Friedewald equation
3
Description
Serum HDL
Timepoint
Month 1,3,6
Method of measurement
by using biochemical kits (Monobind ELISA kit)
4
Description
serum total cholostrol
Timepoint
Month 1,3,6
Method of measurement
by using biochemical kits (Monobind ELISA kit)
5
Description
serum fasting blood sugar
Timepoint
Month 1,3,6
Method of measurement
by using biochemical kits (Monobind ELISA kit)
Intervention groups
1
Description
Intervention group: In this study, all subjects (103 people) received intervention. Intervention included financial incentives, seasonal diet, nutritional training, and physical activity.Participants were followed for 12 months. For the first 6 months of each month, they were given diet, nutrition, and physical activity training and encouraged if they lost weight. After the end of 6 months, they were asked not to go back and continue the same lifestyle and training they had seen to maintain their weight. Body composition and lipid profile were measured again at 12 months. People who kept their weight constant for six months received financial incentives
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nutritional Science and Food Technology
Full name of responsible person
Dr Yahya Pasdar
Street address
School of Nutritional Science and Food Technology, Next to Farabi Hospital, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 2005
Email
yahya.pasdar@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice– Chancellery of Research & Technology Affairs, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Darbandi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp
City
kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2015
Email
m.darbandi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Yahya Pasdar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 2005
Email
yahya.pasdar@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Darbandi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2015
Email
m.darbandi@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available