Protocol summary

Study aim
1- Determining the effect of educational intervention program based on the Health Action Process Approach to reduce the consumption of sweets in mothers referring to health centers
Design
In this study, 216 mothers will be randomly selected from mothers referring to four health centers in Shiraz. then, these participants are divided into three groups of pre intenders, intenders, and actors in the field of confectionery consumption, then the participants in each group are randomly assigned to two groups of intervention and control.
Settings and conduct
All three intervention groups will receive a training program that is appropriate to the stage they are in. After intervention, data were collected at two points, two months after the intervention and six months after the intervention in both intervention and control groups by questionnaires.
Participants/Inclusion and exclusion criteria
-Have at least one child over 6 months, Willing to cooperate and participate in research؛ Having a special diet that bans confectionery sweets
Intervention groups
For the intervention group 1 that are in the foreground phase, their training program will include three training sessions on the disadvantages of confectionery consumption associated with the consumption of sweets and the benefits of reducing the consumption of sweets. For the intervention group 2 who are in the intent to consume confectionery, their training program will include three training sessions for planning how to reduce confectionery consumption. For the intervention group 3, which is in the practice of reducing the consumption of sweets, their training program will include two training sessions for training how to monitor the continued reduction in confectionery consumption.
Main outcome variables
Behavior of sweets consumption

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180113038337N1
Registration date: 2018-08-29, 1397/06/07
Registration timing: retrospective

Last update: 2018-08-29, 1397/06/07
Update count: 0
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Fatemeh Jowzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3839 1345
Email address
f.jozi@iauf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of educational intervention based on health action process approach about the consumption of sweets in women referred to health centers
Public title
Design and evaluation of educational intervention based on health action process approach about the consumption of sweets in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one child over 6 months Willing to cooperate and participate in research
Exclusion criteria:
Having a special diet that bans confectionery sweets
Age
From 18 years old to 85 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 216
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method was used to balance the number of samples assigned to each of the two study groups. Given that in this study, the sample size was 72 in each group, we used 6 blocks of 12. As a result, we have 6 people in each block with the intervention group and 6 people in the control group. Finally, 36 individuals in the intervention group and 36 in the control group.
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
Ethics committee ofShahid Sadoughi University of Medical sciences
Street address
Alam Square, Shohadaye Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.SSU.SPH.REC.1394.108

Health conditions studied

1

Description of health condition studied
Reduce the consumption of sweets
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Consumption of sweets in the feed frequency questionnaire
Timepoint
At the beginning of the study, two months and six months after the intervention
Method of measurement
Food Frequency Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: The intervention group1is Mothers who are in the field of pre-intention consumption of sweets. Their training program is about the disadvantages of confectionery consumption related to the consumption of sweets and the benefits of reducing the consumption of sweets.
Category
Behavior

2

Description
Intervention group: The intervention group2 is mothers who are in the intent to consume sweets. Their training program will include training on how to reduce confectionery consumption.
Category
Behavior

3

Description
Intervention group:The intervention group3 will have mothers who will be in the practice phase of reducing the consumption of sweets and their curriculum will teach you how to monitor to continue to reduce the consumption of sweets
Category
Behavior

4

Description
Control group: Control group that will not receive any intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Abolfazl Health Center
Full name of responsible person
Aliasghar Masih Nejad
Street address
Nasr Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7135761147
Phone
+98 71 3731 9533
Email
valfajr@sums.ac.ir

2

Recruitment center
Name of recruitment center
Mohsen Eftekhar Health Center
Full name of responsible person
Maasomeh Mosavi
Street address
Koye zahra Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7135761147
Phone
+98 71 3726 1268
Email
valfajr@sums.ac.ir

3

Recruitment center
Name of recruitment center
Valiasr Health Center
Full name of responsible person
Maryam Saeed Firoozabadi
Street address
Rahmat Blvd.,South Bahonar St.,Shiraz Town
City
Shiraz
Province
Fars
Postal code
71678863
Phone
+98 71 3837 1601
Email
enghelab@sums.ac.ir

4

Recruitment center
Name of recruitment center
Namazi Health Center
Full name of responsible person
Hamid Zaraee
Street address
Sibiye Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7135761147
Phone
+98 71 3213 1388
Email
valfajr@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Alam Square, Shohadaye Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
f.jozi@iauf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Jowzi
Position
Phd candidate in Health Education & Promotion Yazd Shahid Sadoughi University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Alam Square, Shohadaye Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
f.jozi@iauf.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Jowzi
Position
Phd candidate in Health Education & Promotion Yazd Shahid Sadoughi University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Alam Square, Shohadaye Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
f.jozi@iauf.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Jowzi
Position
Phd candidate in Health Education & Promotion Yazd Shahid Sadoughi University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Alam Square, Shohadaye Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
f.jozi@iauf.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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