Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000722493
Ethics application status
Approved
Date submitted
20/05/2016
Date registered
1/06/2016
Date last updated
1/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing self-reported speed of eating with an objective measure of eating rate.
Scientific title
Comparing self-reported speed of eating with an objective measure of eating rate in healthy young adults.
Secondary ID [1] 289258 0
None
Universal Trial Number (UTN)
U1111-1183-5035
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating rate 298837 0
Condition category
Condition code
Diet and Nutrition 298896 298896 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The time to eat a lunch meal will be recorded on three occasions. Each meal will weigh 550g. The composition of the meals will differ with the proportion of starchy carbohydrate and non-starchy vegetables . The starchy carbohydrate will be rice or penne pasta. The composition of the meals are: Stir-fried beef (100g); Dolmio pasta sauce (100g); white rice or penne pasta (100g); and mixed vegetables (250g). Stir-fried beef (100g); Dolmio pasta sauce (100g); white rice or penne pasta (150g); and mixed vegetables (200g). Stir-fried beef (100g); Dolmio pasta sauce (100g); white rice or penne pasta (200g); and mixed vegetables (150g).

The washout will be one week. Participants will be asked to arrive having fasted for a minimum of 2.5 hour.
Intervention code [1] 294803 0
Lifestyle
Intervention code [2] 294901 0
Behaviour
Comparator / control treatment
Participants will self-report on their general eating habits using a previously published validated eating habits questionnaire (Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. Journal of Psychosomatic Research. 1985;29(1):71-83).
Self-reported speed of eating will be specifically assessed using a previously published question (Sasaki S, Katagiri A, Tsuji T, Shimoda T, Amano K. Self-reported rate of eating correlates with body mass index in 18-y-old Japanese women. Int J Obes (Lond). 2003;27(11):1405-10).
Control group
Active

Outcomes
Primary outcome [1] 298367 0
Comparison of subjective (self-reported) and objective (timed) eating rate. The subjective rate will be self-reported using a previously published question (Sasaki S, Katagiri A, Tsuji T, Shimoda T, Amano K. Self-reported rate of eating correlates with body mass index in 18-y-old Japanese women. Int J Obes (Lond). 2003;27(11):1405-10). The objective eating rate will be determined by the investigator recording the time taken to eat each meal. As each person consumes a meal on three occasions, the average time taken (minutes) will be calculated.
Timepoint [1] 298367 0
The questionnaire regarding self-reported eating rate will be administered at baseline and then again two weeks after the completion of the last meal.

Objective eating rate will be measured on three occasions: after baseline at one week intervals thereafter.
Primary outcome [2] 298368 0
Rate of eating (g/min): The amount a participant consumes at the lunch meal will be divided by the meal duration to determine grams of food eaten per minute.

A digital clock will be used to determine start and stop times of all participants. These times will be recorded to the nearest second to determine meal duration. The start and stop points will be defined as when food first enters the participant’s mouth, and when the participant swallows their last mouthful. Participants will be unaware of their meal duration and eating rate being recorded.
Timepoint [2] 298368 0
The start and stop points are defined as when food first enters the participant’s mouth, and when the participant swallows their last mouthful. Each of the three meals, seperated by one week, will be timed.
Secondary outcome [1] 323953 0
Duration of meal: The start and stop points of eating will be recorded by the researcher when food first enters the participant’s mouth and when the participant swallows their last mouthful. The duration of the meal (in minutes and seconds) will be calculated as the difference between the start and stop times.
Timepoint [1] 323953 0
The duration of meal will be measured on three occasions: after baseline at one week intervals thereafter.

Eligibility
Key inclusion criteria
University students
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with special dietary requirements that we cannot cater to

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2016
Date of last participant enrolment
Anticipated
Actual
4/03/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 7889 0
New Zealand
State/province [1] 7889 0
Otago

Funding & Sponsors
Funding source category [1] 293638 0
University
Name [1] 293638 0
University of Otago
Country [1] 293638 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 292472 0
None
Name [1] 292472 0
Address [1] 292472 0
Country [1] 292472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295075 0
University of Otago Human Ethics Committee
Ethics committee address [1] 295075 0
Department of Human Nutrition
PO Box 56
Dunedin
9054
Ethics committee country [1] 295075 0
New Zealand
Date submitted for ethics approval [1] 295075 0
02/02/2015
Approval date [1] 295075 0
16/02/2015
Ethics approval number [1] 295075 0
14/204

Summary
Brief summary
Self-reported eating rate is commonly used on a population level to show associations between eating rate and health-risks/non-communicable diseases. However, there is little to suggest the applicability of self-reported eating rate in a clinical setting, as well as, clear clarification as to what is fast and slow eating and at which rates do these risks occur. The primary objective of this study was to compare objective eating rate with self-reported eating rate to establish the applicability of self-reported eating rate in a clinical setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66014 0
Dr Bernard Venn
Address 66014 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 66014 0
New Zealand
Phone 66014 0
+6434795068
Fax 66014 0
Email 66014 0
[email protected]
Contact person for public queries
Name 66015 0
Dr Bernard Venn
Address 66015 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 66015 0
New Zealand
Phone 66015 0
+6434795068
Fax 66015 0
Email 66015 0
[email protected]
Contact person for scientific queries
Name 66016 0
Dr Bernard Venn
Address 66016 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 66016 0
New Zealand
Phone 66016 0
+6434795068
Fax 66016 0
Email 66016 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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