Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000636752
Ethics application status
Approved
Date submitted
3/06/2013
Date registered
5/06/2013
Date last updated
9/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of an Australianised Mediterranean diet in healthy volunteers aged 65 years and older - MedLey Trial
Scientific title
Feasibility of an Australianised Mediterranean diet in healthy volunteers aged 65 years and older - MedLey Trial
Secondary ID [1] 282534 0
Nil
Universal Trial Number (UTN)
Trial acronym
MedLey Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition and dietetics 289201 0
Condition category
Condition code
Diet and Nutrition 289530 289530 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will be recruited from a list of participants from previous trials who expressed their willingness to participate in future studies and through word of mouth. Volunteers who respond will be telephoned to participate in a screening questionnaire to determine eligibility and enrolled in the study. The study is comprised of 3 clinic visits. At the first visit, volunteers will provide consent and will have their weight and height measured. They will be asked to maintain their habitual diet for 1 week. During this week they will complete dietary quesitonnaires including a food frequency questionnaire and a 4 day weighed food record to collect dietary information including amount, frequency and portion size. At the end of this week volunteers will return to the Nutritional Physiology Research Centre with their dietary questionnaires. Weight will be assessed. Volunteers will then meet with the research dietitian for 30-45 minutes and the AusMed diet will be explained in detail. They will receive a resource pack which contains a menu guide, sample menu, fruit and vegetable lists, tips for eating out and recipe modification, a recipe book, as well as two weekly dietary checklists. The AusMed diet will be adjusted to meet energy needs and individual taste preferences. Volunteers will receive staple foods to aid with compliance. For the following 2 weeks, volunteers will follow the AusMed diet using the instructions provided. During this 2 week period volunteers will fill out a second weighed food record. After 2 weeks volunteers will return to the Nutritional Physiology Research Centre to return their dietary checklists and weighed food records. Weight will be measured a third time. Volunteers will be asked to fill in a second Food Frequency Questionnaire based on their intake over the last 2 weeks (i.e. while on the AusMed diet). Volunteers will be required to fill out a feasibility questionnaire, which will capture how the volunteers felt about adhering to the AusMed diet and any problems they encountered. This feasibility questionnaire will also assess the usefulness of the resource pack provided.
Intervention code [1] 287199 0
Other interventions
Comparator / control treatment
N/A - this is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289677 0
Acceptability of AusMed diet will be determined using a questionnaire developed by the researchers to specifically capture this information. This questionnaire captures information on satiety, how easy it was to follow, were there any difficulties faced with following the AusMed diet and the usefulness of provided resources such as the recipe book etc.
Timepoint [1] 289677 0
Immediately after particpants have completed 2 weeks of consuming the AusMed diet.
Secondary outcome [1] 302991 0
Satiety of AusMed diet will be determined using a questionnaire developed by the researchers to specifically capture this information. This questionnaire captures information on satiety, how easy it was to follow, were there any difficulties faced with following the AusMed diet and the usefulness of provided resources such as the recipe book etc.
Timepoint [1] 302991 0
Immediately after particpants have completed 2 weeks of consuming the AusMed diet.
Secondary outcome [2] 302996 0
Palatability of the AusMed diet using a questionnaire developed by the researchers to specifically capture this information. This questionnaire captures information on satiety, how easy it was to follow, were there any difficulties faced with following the AusMed diet and the usefulness of provided resources such as the recipe book.
Timepoint [2] 302996 0
Immediately after particpants have completed 2 weeks of consuming the AusMed diet.
Secondary outcome [3] 302998 0
Ease of incorporation AusMed diet into an Australian lifestyle including cost, time of food preparation, ability to shop for and cook the foods recommended on the diet, will be determined using a questionnaire developed by the researchers to specifically capture this information. This questionnaire captures information on satiety, how easy it was to follow, were there any difficulties faced with following the AusMed diet and the usefulness of provided resources such as the recipe book etc.
Timepoint [3] 302998 0
Immediately after particpants have completed 2 weeks of consuming the AusMed diet.
Secondary outcome [4] 303012 0
Nutrient intake compared to habitual diet will be assessed using a food frequency questionnaire and a 4 day weighed food record
Timepoint [4] 303012 0
Nutrient intake will be assessed at the end of the first week and then again at the end of the study at 3 weeks, following 2 weeks of consumption of the AusMed diet.
Secondary outcome [5] 303013 0
Comparison of dietary intake data between Food Frequency Questionanire and 4 day Weighed Food Record
Timepoint [5] 303013 0
At baseline and then after 2 weeks of consumption of the AusMed diet.
Secondary outcome [6] 303014 0
Usefulness of resources provided including sample menu, recipe book, advice for eating out, and appropriateness of foods given using feedback obtained using a questionnaire developed by the researchers to specifically capture this information. This questionnaire captures information on satiety, how easy it was to follow, were there any difficulties faced with following the AusMed diet and the usefulness of provided resources such as the recipe book etc.
Timepoint [6] 303014 0
At the end of the study at week 3.

Eligibility
Key inclusion criteria
Free living men and women, omnivorous, free of dementia and cognitive impairment, proficient in English, aged 65 years and above.
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol
Actively undertaking a weight loss program
Use of appetite suppressants or Orlistat (Xenical)
Previous stroke
History of traumatic head/brain injury, neurological or psychiatric conditions

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be recruited from a list of participants from previous trials who expressed their willingness to participate in future studies, and through word-of-mouth. These participants will receive a letter in the mail, after which they will be contacted by phone or email. Volunteers who express interest will leave their contact details with the investigators. At a convenient time, the volunteer will be telephoned to participate in a screening questionnaire to determine eligibility. If eligible, volunteers will be informed over the phone and they will be enrolled in the study and allocated an ID code. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Volunteers will maintain their habitual diet for 1 week then consume the AusMed diet for 2 weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For dietary data, descriptive statistics will be peformed for nutrient intakes, and Cohen's D effect sizes calculated for mean intakes and survey responses. Paired sample t-tests will be performed for dietary data and survey data where Likert scales have been used. Statistical significance will be set at P = 0.05. Statistical analyses will be performed using SPSS for Windows (version 20.0; SPSS, Chicago, IL).

10 volunteers with similar characteristics to the larger MedLey trial (ACTRN12613000602729) will be recruited to pilot test the AusMed diet. This is based on a similar study by Patch CS et al 20xx JADA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/05/2013
Actual
27/05/2013
Date of last participant enrolment
Anticipated
10/06/2013
Actual
31/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 6922 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287357 0
University
Name [1] 287357 0
University of South Australia - Internal Project Grant Development scheme
Country [1] 287357 0
Australia
Primary sponsor type
Individual
Name
Dr Karen Murphy (Chief Investigator)
Address
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 286103 0
Individual
Name [1] 286103 0
Dr Janet Bryan
Address [1] 286103 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country [1] 286103 0
Australia
Secondary sponsor category [2] 286104 0
Individual
Name [2] 286104 0
Prof Carlene Wilson
Address [2] 286104 0
Flinders University
GPO Box 2100
Adelaide, SA
5001
Country [2] 286104 0
Australia
Secondary sponsor category [3] 286105 0
Individual
Name [3] 286105 0
Prof Jonathan Hodgson
Address [3] 286105 0
University of Western Australia
35 Stirling Highway
CRAWLEY WA
6009
Country [3] 286105 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289334 0
University of South Australia
Ethics committee address [1] 289334 0
Mawson Lakes Campus, Mawson Lakes Boulevard, Mawson Lakes, 5095, South Australia
Ethics committee country [1] 289334 0
Australia
Date submitted for ethics approval [1] 289334 0
Approval date [1] 289334 0
02/05/2013
Ethics approval number [1] 289334 0
0000031163

Summary
Brief summary
This is a pilot study designed to test how easy it is to follow an Australianised Mediterranean Diet (AusMed diet) for 2 weeks. This includes an investigation into consumption of nutrients, BMI stability, palatibility, satiety and cost of the diet, and other lifestyle factors which might be affected by the diet. The information we collect will then be used to help refine and change the diet to make it easier to follow in the long term. We hypothesise that with some minor changes, it will be feasible to follow the AusMed diet for 2 weeks.
Trial website
Trial related presentations / publications
Davis C, Bryan J, Hodgson J, Wilson C, Murphy KJ. Older Australians can adhere to a traditional Mediterranean style diet over two weeks: a pilot dietary intervention study. BMC Nutrition 2015, 1:28 (12 November 2015)
Public notes

Contacts
Principal investigator
Name 40202 0
Dr Karen Murphy
Address 40202 0
University of South Australia Nutritional Physiology Research Centre GPO Box 2471 Adelaide, SA 5001
Country 40202 0
Australia
Phone 40202 0
+61 8 8302 1033
Fax 40202 0
Email 40202 0
[email protected]
Contact person for public queries
Name 40203 0
Dr Karen Murphy
Address 40203 0
University of South Australia Nutritional Physiology Research Centre GPO Box 2471 Adelaide, SA 5001
Country 40203 0
Australia
Phone 40203 0
+61 8 8302 1033
Fax 40203 0
Email 40203 0
[email protected]
Contact person for scientific queries
Name 40204 0
Dr Karen Murphy
Address 40204 0
University of South Australia Nutritional Physiology Research Centre GPO Box 2471 Adelaide, SA 5001
Country 40204 0
Australia
Phone 40204 0
+61 8 8302 1033
Fax 40204 0
Email 40204 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
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Documents added automatically
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