Protocol summary

Summary
This study is designed to investigate the effect of the size of food utensils (plate, spoon and fork) on energy intake and amount of food, salad and drinks consumption and also it’s relation to eating habits. Forty overweight and obese staff of Ahvaz University of medical Sciences with age of less than 60, body mass index of more than 25 and not having any obesity co-morbidities and not taking any medication will be recruited randomly and entered to a "cross-sectional designed" study. Those who are on a diet, following an sports program or are drug users will be omitted from the study. A sociodemographic questionnaire, Dutch Eating Behavior, international physical activity and eating habits questionnaire will be filled by interviewing participants and then they will be randomly allocated into blocks and two groups. Each group contains 25 people and the intervention method is unblined. group one which will receive small dining utensils at the first period and large utensil at the second period and group two which will receive large utensil at first period and small utensil at second one. Wash-out period will be 3 weeks. In every intervention period patients will receive a double or 1.5 times the normal portion size, including barbequed chicken breast, steamed rice with saffron, vegetable salad, Dough and coca cola and these foods will be served similarly and separately for each person. The time spent for eating lunch and also the quantity of consumed food and drink will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041516123N7
Registration date: 2016-04-24, 1395/02/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-24, 1395/02/05
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of food intake in Large and small dishware in obese or overweight patients
Public title
Evaluation of the effect of eating utensils sizes on food intake during a meal in obese or overweight patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: age between 19-60 years old; body mass index of equal or more than 25; complete mental and physical health (according to annual medical check-up of university staff) and having no comorbidities of overweight and obesity such as High Blood Pressure; Asthma; Arteriovascular disease and so on. Exclusion criteria: being menopause or premenopausal in women population; being an athlete or doing exercise regularly; following a therapeutic or weight management diet; following any life style or eating related habits modification program or social network; taking weight loss medicine over last three month; taking any sensory disrupting medicine; drug or alcohol addiction; Having metabolic or gastrointestinal disease.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.AJUMS.REC.1394.392

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
Carbohydrate intake
Timepoint
After the intervention
Method of measurement
Food analyzer software, scale, grams

2

Description
Protein intake
Timepoint
After the intervention
Method of measurement
Food analyzer software, scale, grams

3

Description
Fat intake
Timepoint
After the intervention
Method of measurement
Food analyzer software, scale, grams

4

Description
Energy intake
Timepoint
After the intervention
Method of measurement
Food analyzer software, scale, grams

Secondary outcomes

1

Description
Mayonnaise intake
Timepoint
At the same time with intervention
Method of measurement
Scale, grams

2

Description
Salad consumption
Timepoint
At the same time with intervention
Method of measurement
Scale, grams

3

Description
Chiken consumption
Timepoint
At the same time with intervention
Method of measurement
Scale, grams

4

Description
Rice consumption
Timepoint
At the same time with intervention
Method of measurement
Scale, grams

Intervention groups

1

Description
Intervention group: patients will receive small size eating utensil including small size ceramic dining plate (19.5 Cm), small spoon (5 ml), small fork and a 120 ml glass. Each patient in the intervention group will receive a lunch package consisted of 270 grams of barbecued chicken breast (seasoned with onion, saffron and lime juice), 600 grams of steamed rice and two medium size tomatoes as optional side dish, 430 grams of vegetable salad with 42 grams mayonnaise which will be served separately.
Category
Lifestyle

2

Description
Control group: patients will receive large size eating utensil including large size ceramic dining plate (25 Cm), large spoon (15 ml), large fork and a 120 ml glass. Each patient in control group will receive a lunch package consisted of 270 grams of barbecued chicken breast (seasoned with onion, saffron and lime juice), 600 grams of steamed rice and two medium size tomatoes as optional side dish, 430 grams of vegetable salad with 42 grams mayonnaise which will be served separately.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdis Vakili
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mr. Dianat
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdis Vakili
Position
BSc in Nutrition Science
Other areas of specialty/work
Street address
Golestan St, Ahvaz Jundishapur University of Medical Sciences, Paramedicine school
City
Ahvaz
Postal code
Phone
+98 61 3337 5717
Fax
Email
mahdisvakili@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Scineces
Full name of responsible person
Mahdis Vakili
Position
BSc in Nutrition Science
Other areas of specialty/work
Street address
Golestan St, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3337 5717
Fax
Email
mahdisvakili@ymail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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