Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000341224
Ethics application status
Approved
Date submitted
28/04/2009
Date registered
25/05/2009
Date last updated
25/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of dietary intake assessment methods in healthy older adults
Scientific title
Validation of dietary intake assessment methods in healthy older adults
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutritional status of older adults 4679 0
Condition category
Condition code
Diet and Nutrition 4991 4991 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of diet intake using 3-day weighed food record, Cancer Council Food Frequency Questionnaire and 24-hour recall methods. All participants will be asked to complete all three methods of estimating dietary intake. Duration of observation differs for each method:
3-day weighed food record will be conducted once. Participants choose
two weekdays and one weekend-day within a two-week period. They will be
provided with a set of scales and three separate record sheets to record all
food and beverages consumed on these days. Instructions and a demonstration
will be conducted during the home-visit. A prepaid return envelope is provided
in order to return the scales and food record sheets.
Cancer Council Food Frequency Questionnaire will be conducted once during the home visit. Participants are asked to estimate the frequency of consumption of
various foods over the previous 12-months.
24-hour recall will be conducted twice; the first time during the home-visit,
and then again two weeks later. It involves participants recalling all foods
and drinks consumed in the previous complete 24 hour period.
To clarify;
The home visit includes; initial 24-h recall, food frequency questionnaire and
instructions for weighed food record.
Then participants are given two weeks to complete and return a 3-day weighed
food record
Finally, two weeks after the initial home visit a second 24-hour recall will be
conducted via telephone.
Intervention code [1] 4442 0
Not applicable
Comparator / control treatment
There is no comparison group, since comparisons will not be made between
participants. Prospective observation includes the 3-day weighed food record since this is recorded in real time.
Retrospective observation includes both the Cancer Council Food Frequency
Questionnaire and both of the 24-hour recalls. These methods look back to the
previous 12 months, and 24-hours respectively.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5834 0
Dietary intake from 3-day weighed food record
Timepoint [1] 5834 0
Completed within 2 weeks of recruitment
Secondary outcome [1] 241842 0
Dietary intake from Cancer Council Food Frequency Questionnaire
Timepoint [1] 241842 0
Questionnaire conducted at recruitment
Secondary outcome [2] 241843 0
Dietary intake from 24-hour recall
Timepoint [2] 241843 0
Conducted at recruitment and then 2 weeks after recruitment

Eligibility
Key inclusion criteria
Community-dwelling adults
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged less than 70 years, or in residential care

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1630 0
5042
Recruitment postcode(s) [2] 1631 0
5043
Recruitment postcode(s) [3] 1632 0
5048
Recruitment postcode(s) [4] 1633 0
5045
Recruitment postcode(s) [5] 1634 0
5051

Funding & Sponsors
Funding source category [1] 4861 0
University
Name [1] 4861 0
Flinders University, Faculty of Health Sciences
Country [1] 4861 0
Australia
Primary sponsor type
Individual
Name
Dr Michelle Miller
Address
Department of Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide 5001
Australia
Country
Australia
Secondary sponsor category [1] 4399 0
None
Name [1] 4399 0
Address [1] 4399 0
Country [1] 4399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6922 0
Flinders Clinical Research and Ethics Committee
Ethics committee address [1] 6922 0
GPO Box 2100
Adelaide 5001
Australia
Ethics committee country [1] 6922 0
Australia
Date submitted for ethics approval [1] 6922 0
10/03/2009
Approval date [1] 6922 0
12/03/2009
Ethics approval number [1] 6922 0
68/09

Summary
Brief summary
At present few methods of determining dietary intake in this group have been validated. The aim of the study is to evaluate the validity of two dietary assessment instruments (Cancer Council’s Food Frequency Questionnaire (FFQ) and duplicate 24h recall) against a reference technique (3-day weighted record) in a sample of community-dwelling older adults. This will potentially provide Dietitians (particularly researchers) with a simple, valid tool to assess dietary intake in this population
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29538 0
Address 29538 0
Country 29538 0
Phone 29538 0
Fax 29538 0
Email 29538 0
Contact person for public queries
Name 12785 0
Dr Michelle Miller
Address 12785 0
Dept Nutrition and Dietetics
Flinders University
GPO Box 2001
Adelaide SA 5001
Country 12785 0
Australia
Phone 12785 0
+61 8 8204 5328
Fax 12785 0
Email 12785 0
[email protected]
Contact person for scientific queries
Name 3713 0
Dr Michelle Miller
Address 3713 0
Dept Nutrition and Dietetics
Flinders University
GPO Box 2001
Adelaide SA 5001
Country 3713 0
Australia
Phone 3713 0
+61 8 8204 5328
Fax 3713 0
Email 3713 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.