Effectiveness of nutrition education intervention on nutrition behaviors and weight loss of obese or overweight women using Protection Motivation Theory.
Purpose of the study: effectiveness of nutrition education intervention on nutrition behaviors and weight loss of obese or overweight women using Protection Motivation Theory. Study design: randomized clinical trial with two intervention groups and one control group. Study population: obese and overweight women who attended to nutrition clinic. Inclusion criteria: being obese and overweight based on BMI (25-29.9 considered overweight, more than 30 considered obese); lack of diseases such as diabetes, cardiovascular, thyroid and also people who are treating by drugs that may change weight and appetite. Exclusion criteria: pregnancy; being infected with diseases that may occur during intervention and interfere with diet. Sample size: 150 subjects in total, 50 sample per groups. Study design: motivation intervention for two intervention groups (100 women), intention intervention for one intervention group. Outcome: weight loss of overweight and obese women
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051817736N1
Registration date:2014-06-12, 1393/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-12, 1393/03/22
Registrant information
Name
Seyed Kamaladdin Mirkarimi
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 1553 2872
Email address
k.mirkarimi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Isfahan University of Medical Science
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of nutrition education intervention on nutrition behaviors and weight loss of obese or overweight women using Protection Motivation Theory.
Public title
Nutrition education on weight loss based on protection motivation theory
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being obese and overweight based on BMI (25-29.9 considered overweight, more than 30 considered obese); lack of diseases such as diabetes, cardiovascular, thyroid and also people who are treating by drugs that may change weight and appetite. Exclusion criteria: pregnancy; being infected with diseases that may occur during intervention and interfere with diet.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Deputy of Research of Isfahan University of Medical Science
Street address
Azadi Square, Isfahan University of Medical Science
City
Isfahan
Postal code
8174673461
Approval date
2013-10-05, 1392/07/13
Ethics committee reference number
392501
Health conditions studied
1
Description of health condition studied
Obesity or overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Modification of Protection Motivation Theory Constructs
Timepoint
2 weeks, 2 and 6 month follow up after intervention
Method of measurement
Questionnaire based on Protection Motivation Theory Constructs
Secondary outcomes
1
Description
weight loss
Timepoint
2 weeks, 2 and 6 month after intervention
Method of measurement
Measuring Body Mass Index
Intervention groups
1
Description
Motivation intervention group is consisted of 50 women that they were received nutritional education, firstly that these sessions are including 2 sessions in one week that each session is 45 to 60 minutes. In the next stage, motivation intervention was done using a psychologist who is professional; these sessions are including 4 sessions in 2weeks (2 sessions per week) that each session is 45 to 60 minutes. Despite this intervention, a pamphlet regarding obesity and overweight based on protection motivation theory constructs (pamphlet content was proved by 4 authorized people in health education and promotion) was used.
Category
Behavior
2
Description
Motivation and intention intervention group is consisted of 50 women that they were received nutritional education, firstly that these sessions are including 2 sessions in one week that each session is 45 to 60 minutes. In the next stage, motivation intervention was done using a psychologist who is professional; these sessions are including 4 sessions in 2weeks (2 sessions per week) that each session is 45 to 60 minutes. Despite this intervention, a pamphlet regarding obesity and overweight based on protection motivation theory constructs (pamphlet content was proved by 4 authorized people in health education and promotion) was used. Difference of this group compared to motivation intervention is in this way that women in this group followed a determined plan to lose weight that remind them to lose weigh in a definite timeline.
Category
Behavior
3
Description
Control group is consisted of 50 women that they were received nutritional education, firstly that these sessions are including 2 sessions in one week that each session is 45 to 60 minutes
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Clinic
Full name of responsible person
Seyed Kamaladdin Mirkarimi
Street address
Dr Eshghinia Department, 5 floor, Sina Apartment, 13 Edalat alley, Valiasr street, Gorgan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research of Isfahan University of Medical Science
Full name of responsible person
Dr Firouzeh Mostafavi, Assiastant Professor Isfahan University of Medical Science
Street address
Isfahan, Azadi Square, Isfahan University of Medical Science, Health education and promotion Department
City
Isfahan
Grant name
از محل برنامه تحقیقات و فناوری دانشگاه علوم پزشکی اصفهان
Grant code / Reference number
Provided by Deputy of research of Isfahan University of Medical Science
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research of Isfahan University of Medical Science
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
Isfahan University of Medical Science
Full name of responsible person
Seyed Kamaladdin Mirkarimi
Position
Ph.D candidate of Health education and Promotion
Other areas of specialty/work
Street address
Azadi Square, Isfahan University of Medical Science, Health education and Promotion
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2752
Fax
Email
k.mirkarimi@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Dr Samira Eshghinia
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Golestan University of Medical Science, Deputy of Research
City
Gorgan
Postal code
Phone
+98 17 1553 2872
Fax
Email
dreshghinia@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)