The success of weight loss programs resulting from various behavioral factors has always been doubted. As such, some behavior change theories have been introduced into weight loss interventions. The present study investigates the efficacy of the transtheoretical model, a behavior change in combined with a balanced low calorie diet on weight loss in obese women. The results of this study can be effective in the weight management of the obese.
This study is a randomized clinical trial conducted on 80 obese women (body mass index 30-40 Kg/m²) on their first visit to nutrition clinic who volunteered to participate in this study. Initially, the demographic and anthropometric data, nutritional behavior and the transtheoretical model constructs data, the stages and process of changes, decision balance and self efficacy and 3-day food records were collected using the questionnaires. Next, blood samples were obtained for the measurement of fasting blood sugar and insulin. Subjects will be randomly assigned to two groups with a balanced low calorie diet, one with a transtheoretical model and the other without. Balanced low calorie diet is an individualized diet with an energy deficit of 500 calories of daily energy intake calculated from 3-day food records for every subject. In the intervention group with the model, nutrition education will be conducted over six one-hour sessions per week for each individual. Questionnaires will be completed at 3 and 6 months after intervention and re-sampling of blood will be taken 6 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102911299N1
Registration date:2012-12-18, 1391/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-18, 1391/09/28
Registrant information
Name
Fatemeh Ghannadiasl
Name of organization / entity
Mohaghegh Ardabili University
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 0806
Email address
ghannadiasl@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center, Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effectiveness of a balanced low calorie diet with and without the transtheoretical model on weight loss in obese women
Public title
Effectiveness of nutritional education on weight loss
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1- Apparently healthy women in their first visit to nutrition clinic
2- Aged 18-50 years
3- BMI ranging from 30 to 40 kg/m²
4- Education: at least a diploma
5- Non- pregnant, Non- lactating, Non- menopause
6- Lack of participation in any program of weight loss over the past 6 months
7- Participate in the study until the end of intervention
Exclusion criteria:
1- Use of dietary supplement
2- Use of laxatives
3- Use of diuretics
4- Pregnancy or menopause
5- Not using recommended diet
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the subjects will be assigned to intervention or control group based on even/odd numbers of admission. Also the subjects and the outcomes assessor are blind to allocated treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, East Azarbaijan, Iran
City
Tabriz
Postal code
Approval date
2012-11-12, 1391/08/22
Ethics committee reference number
91132
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Processes of Change
Timepoint
At baseline, 3 and 6 months after intervention
Method of measurement
Processes of Change Questionnaire
2
Description
Stages of Change
Timepoint
At baseline, 3 and 6 months after intervention
Method of measurement
URICA Questionnaire
3
Description
Decisional Balance
Timepoint
At baseline, 3 and 6 months after intervention
Method of measurement
Decisional Balance Questionnaire
4
Description
Self efficacy
Timepoint
At baseline, 3 and 6 months after intervention
Method of measurement
WEL Questionnaire
5
Description
Anthropometric parameters (weight, waist circumference, hip circumference, body mass index, waist to hip ratio)
Timepoint
At baseline, 3 and 6 months after intervention
Method of measurement
Standard procedures using scale, tape and formula
6
Description
Dietary intake
Timepoint
At baseline, 3 and 6 months after intervention
Method of measurement
3-day food records Questionnaire
7
Description
Nutritional behaviors
Timepoint
At baseline, 3 and 6 months after intervention
Method of measurement
Nutritional behaviors Questionnaire
8
Description
Biochemical parameters: fasting blood sugar and insulin and HOMA-IR index
Intervention group: Individual balanced low calorie diet (an energy deficit of 500 calories of daily energy intake calculated from 3-day food records for every subject and the distribution of energy: <30% from fat, 55-60% from carbohydrate and 10-15% from protein) with six one-hour nutritional education sessions per week about Food Guide Pyramid, Food Exchange Systems, goal setting for weight loss, self monitoring, and stimulus control
Category
Lifestyle
2
Description
Control group: Individual balanced low calorie diet(an energy deficit of 500 calories of daily energy intake calculated from 3-day food records for every subject and the distribution of energy: <30% from fat, 55-60% from carbohydrate and 10-15% from protein)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Clinic
Full name of responsible person
Fatemeh Ghannadiasl
Street address
Shams Alley, Sarcheshmeh Square, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Research Center, Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Nutritional Research Center, Atar-Neishaboori Street, Golgasht Street, Tabriz, East Azarbaijan, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Research Center, Vice chancellor for research, Tabriz 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
Mohaghegh Ardabili University
Full name of responsible person
Fatemeh Ghannadiasl
Position
PhD Student
Other areas of specialty/work
Street address
Shams Alley, Sarcheshmeh Square, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1223 3048
Fax
Email
Ghannadiasl@uma.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Mahdavi
Position
Professor, Nutrition and Biochemistry Department
Other areas of specialty/work
Street address
Faculty of Health and Nutrition, Atar-Neishaboori Street, Golgasht Street, Tabriz, East Azarbaijan, Iran
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
mahdavir@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Fatemeh Ghannadiasl
Position
PhD Student
Other areas of specialty/work
Street address
Shams Alley, Sarcheshmeh Square, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1223 3048
Fax
Email
Ghannadiasl@uma.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)