Effect of Nutrition Education on Healthy Eating Choice (Low-fat), Carbohydrate Counting and Physical Activity in Type 2 Diabetic Adults Using Theory of Planned Behavior (TPB)
Nutritional behavior change in diabetics is critical and entails effective education. Thus the current research aims to do an educational intervention to promote healthy food options (low-fat), carbohydrate counting and physical activity in type 2 diabetic adults (25 to 59 years of age) using Theory of Planned Behavior (TPB). To do so, an elicitation study will be performed in 30 patients representing the main sample. Using face-to-face interview patients will mention advantages and disadvantages of performing the behavior, important groups or people who would approve or disapprove of and any conditions and factors that may prevent or help doing the behavior. Following content analysis regarding low-fat food options, carbohydrate counting and physical activity, the main questionnaire (valid and reliable) will be designed. Participants (n=142) will be randomly (using permutted block randomization) assigned into two equal (n=71) control and intervention groups all of which are diagnosed with Type 2 diabetes for at least past 2 years and have no debilitating complications to prevent them from participating in the study. Both groups will complete the main questionnaire and blood sample will be taken to determine triglyceride and LDL-cholesterol at baseline. After multiple regression analysis and structural equation analysis and recognizing changeable beliefs, focus group discussion (6 two-hour sessions including 7 to 12 patients in each) will be performed in the intervention which begins with a brief explanation by the trainer to make patients involved, while control won’t get any intervention, except nutritional counseling, which both groups routinely get. At the end (about one and half months) question completeness and blood sampling will be done.
General information
Acronym
TPB (Theory of Planned Behavior), T2D (Type 2 Diabetes)
IRCT registration information
IRCT registration number:IRCT2013040912961N1
Registration date:2013-07-26, 1392/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-26, 1392/05/04
Registrant information
Name
Reza Daryabeygi Khotbesara
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4463
Email address
r-daryabeygi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research- Tehran University of Medical Sciences
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nutrition Education on Healthy Eating Choice (Low-fat), Carbohydrate Counting and Physical Activity in Type 2 Diabetic Adults Using Theory of Planned Behavior (TPB)
Public title
Effect of Nutrition Education on Type 2 Diabetics' Healthy Food Options and Physical Activity Behaviors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: adults (25 to 59 years of age); taking usual lipid- and glucose-lowering drugs; had participated in routine nutrition classes for diabetics before the intervention; diagnosed with diabetes for at least past 2 years.
Exclusion Criteria: complications (nephropathy, neuropathy and retinopathy) including cardiovascular disease that may prevent patients from participating in the study.
Age
From 25 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
142
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
Vice-Chancellor for Research, Tehran University of Medical Sciences
Street address
4th fl, Main Organization of Tehran University of Medical Sciences, Qods corner, Keshavarz Blv, Tehran
City
Tehran
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
3549/130/د/91
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Low-fat food choice behavior
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Liker score- using questionnaire
2
Description
Low-fat food choice intention
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Liker score- using questionnaire
3
Description
Subjective norm for low-fat food choice
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Liker score- using questionnaire
4
Description
Attitude toward low-fat food choice
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Liker score- using questionnaire
5
Description
Perceived behavioral control over low-fat food choice
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Liker score- using questionnaire
6
Description
Carbohydrate counting behavior
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
7
Description
Carbohydrate counting intention
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
8
Description
Attitude toward carbohydrate counting
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
9
Description
Subjective norm for carbohudrate counting
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
10
Description
Perceived behavioral control over carbohydrate counting
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
11
Description
Physical activity behavior
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
12
Description
Physical activity intention
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
13
Description
Attitude toward physical activity
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
14
Description
Subjective norm for physical activity
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
15
Description
Perceived behavioral control over physical activity
Timepoint
before intervention and at the end, after intervention
Method of measurement
average Likert score- using questionnaire
16
Description
Education
Timepoint
During intervention
Method of measurement
feedback
Secondary outcomes
1
Description
Triglyceride
Timepoint
before intervention and at the end, after intervention
Method of measurement
mg/dl- colorimetric laboratory test
2
Description
LDL-cholesterol
Timepoint
before intervention and at the end, after intervention
Method of measurement
mg/dl- colorimetric laboratory test
3
Description
Age
Timepoint
before intervention (baseline)
Method of measurement
questionnaire
4
Description
Sex
Timepoint
before intervention (baseline)
Method of measurement
questionnaire
5
Description
Job
Timepoint
before intervention (baseline)
Method of measurement
questionnaire
6
Description
Level of education
Timepoint
before intervention (baseline)
Method of measurement
questionnaire
7
Description
Body mass index (BMI)
Timepoint
before and after intervention
Method of measurement
Weight divided by height squared
Intervention groups
1
Description
Education in intervention group will be based on focus group discussion. Patients will receive totally 6 two-hour session (about one and half months long), beside routine diabetic classes.
Category
Behavior
2
Description
No interventional education will be done in control group (except routine diabetic classes)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Diabetes Society
Full name of responsible person
Dr Asadollah Rajab
Street address
No 46, Ramin Malakooti St, Patris Lomomba St, Sattarkhan St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sceineces
Full name of responsible person
Vice-chancellor for research
Street address
4th fl, Main Organization of Tehran University of Medical Sciences, Qods corner, Keshavarz Blv, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sceineces
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
Full name of responsible person
Reza Daryayabeygi Khotbesara
Position
MSc student of nutrition
Other areas of specialty/work
Street address
No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 18 2423 3937
Fax
Email
r-daryabeygi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedali Keshavarz
Position
PhD/ Professor of Nutrition-
Other areas of specialty/work
Street address
No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4463
Fax
Email
s_akeshavarz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Daryabeygi Khotbesara
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 18 2423 3937
Fax
Email
r-daryabeygi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)