Comparing the effect of counseling on diet quality and physical activity enhancement with or without behavior counseling on body mass index, body composition and lipid profile of obese and overweight women
Comparing the effect of counseling on diet quality and physical activity enhancement with or without behavior counseling on body mass index, body composition and lipid profile of obese and overweight women
Design
A randomized trial including two groups of intervention and an overall 61 participants who were followed up from the beginning of the study until three subsequent months
Settings and conduct
This study which was held in Urmia city (located in West Azerbaijan state of Iran), 61 eligible women who had been announced of the study through flyers were randomized into two groups of intervention. Both groups received counseling on improving diet quality and increasing physical activity. Only one group received psychological counseling for behavior change. Characteristics of both groups were compared at baseline and after 3 months of followup in regard to BMI, body composition, lipid profile, etc.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being female
BMI=25-40
Being within the age of 18 to 65 years
Exclusion criteria:
lactation or being pregnant or deciding to become pregnant from beginning of the study until the next 4 months
Taking corticosteroid drugs (like prednisolon) and psychotherapic medications including tricyclic drugs (like amitriptyline, imipramine, nortriptyline)
Getting more than 61 scores in General health questionnaire
Intervention groups
The intervention group receiving counseling on diet quality, increasing physical activity and psychological counseling for behavior change
The intervention group receiving counseling on diet quality and increasing physical activity
Main outcome variables
BMI
Body composition
Physical activity level
Lipid profile
Calorie intake
Healthy Eating Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160824029508N7
Registration date:2019-09-17, 1398/06/26
Registration timing:retrospective
Last update:2019-09-17, 1398/06/26
Update count:0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Rasoul Zarrin
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
rasoul.zarrin@uqconnect.edu.au
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
2019-01-05, 1397/10/15
Actual recruitment end date
2019-02-04, 1397/11/15
Trial completion date
2019-05-01, 1398/02/11
Scientific title
Comparing the effect of counseling on diet quality and physical activity enhancement with or without behavior counseling on body mass index, body composition and lipid profile of obese and overweight women
Public title
Comparing the effect of two types of lifestyle intervention on health measures
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being female
BMI=25-40
Being within the age of 18 to 65 years
Exclusion criteria:
Lactation or being pregnant
Planning to become pregnant from beginning of the study until the next 4 months
Having cancer or kidney diseases
Taking corticosteroid drugs (like prednisolone) or psychothrapic medications including tricyclic drugs (like amitriptyline, imipramine, nortriptyline)
Getting scores from 61 to 84 on the General Health Questionnaire
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Actual sample size reached:
61
Randomization (investigator's opinion)
Randomized
Randomization description
After recognition of 61 eligible participants, due to the small sample size of the population (<200), in order to have two groups with equal sizes, restricted randomization, random allocation rule, was applied to randomize the participants into two groups.
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 of Urmia University of Medical Sciences
Street address
Umia University of Medical Sciences, Oorjans Alley, Resalat Blvd, URMIA, IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.UMSU.REC.1397.355
Health conditions studied
1
Description of health condition studied
Overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
2
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Weight
Timepoint
At baseline and after 3 months
Method of measurement
Measured in kg using digital Scale
2
Description
Body mass index
Timepoint
At baseline and after 3 months
Method of measurement
kg/m2, using formula
3
Description
Triglyceride
Timepoint
At baseline and after 3 months
Method of measurement
Measured in milligram per deciliter, using auto-analyzer BT1500
4
Description
Total cholesterol
Timepoint
At baseline and after 3 months
Method of measurement
Measured in milligram per deciliter using auto-analyzer BT1500
5
Description
Low density lipoprotein (LDL-C)
Timepoint
At baseline and after 3 months
Method of measurement
Measured in milligram per deciliter, using auto-analyzer BT1500
6
Description
High density lipoprotein (HDL-C)
Timepoint
At baseline and after 3 months
Method of measurement
Measured in milligram per deciliter using auto-analyzer BT1500
7
Description
Fat free mass
Timepoint
At baseline and after 3 months
Method of measurement
Measured in kg, using InBody770
8
Description
Fat mass
Timepoint
At baseline and after 3 months
Method of measurement
Measured in kg, using InBody770
Secondary outcomes
1
Description
Physical activity level
Timepoint
At baseline and after 3 months
Method of measurement
International physical activity questionnaire short form (IPAQ-SF)
2
Description
Eating behavior
Timepoint
At baseline and after 3 months
Method of measurement
Three Factor Eating Questionnaire-R18 (TFEQ-R18)
3
Description
Calorie intake
Timepoint
At baseline and after 3 months
Method of measurement
Measured in Kcal, using 24 hour diet recall
4
Description
Healthy eating index
Timepoint
At baseline and after 3 months
Method of measurement
Scores measured using 24 hour diet recall
Intervention groups
1
Description
First intervention group: 31 overweight or obese women received counseling on diet quality improvement, increasing physical activity and psychological counseling for behavior change. Demographic characteristics of the participants were recorded at baseline. Health measures including physical activity level, body composition, weight, Body mass index, lipid profile, eating behavior, Healthy Eating Index and calorie intake were assessed at baseline and after 3 months of follow up.
Category
Lifestyle
2
Description
Second intervention group: 30 overweight or obese women received counseling on diet quality improvement and increasing physical activity. Demographic characteristics of the participants were recorded at baseline. Health measures including physical activity level, body composition, weight, Body mass index, lipid profile, eating behavior, Healthy Eating Index and calorie intake were assessed at baseline and after 3 months of follow up.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Imam Khomeini Hospital
Full name of responsible person
Rasoul Zarrin
Street address
Urmia University of Medical Sciences, Orjhans Street, Resalat Blvd, URMIA, IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3277 0397
Email
rasoul.zarrin@uqconnect.edu.au
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
UMSU Central Site, Orjhans Street, Resalat Blvd, URMIA, IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
rasoul.zarrin@uqconnect.edu.au
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Rasoul Zarrin
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, Faculty of Medicine, Pardis Nazlou, 11th km of Nazlou Road,Urmia,Iran
City
Umia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9935
Email
rasoul.zarrin@uqconnect.edu.au
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rasoul Zarrin
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road,Urmia,IranDepartment of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9935
Email
rasoul.zarrin@uqconnect.edu.au
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fateme Dowran
Position
MSc student of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Department of Nutrition, Nazlou Pardis, Sero Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 51 3605 3582
Fax
+98 44 3345 7277
Email
dowran.fa@gmail.com
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