Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001575325
Ethics application status
Approved
Date submitted
7/11/2017
Date registered
24/11/2017
Date last updated
24/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the Nutritional Status of New Zealand Adults in Residential Aged-Care: the New Zealand Nutrition in Aged-care Project (NZNAPs)
Scientific title
The Nutritional Status of Older New Zealand Adults in Residential Care: the New Zealand Nutrition in Aged-care Project (NZNAPs)
Secondary ID [1] 293287 0
nil known
Universal Trial Number (UTN)
Trial acronym
NZNAPs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition Status 305380 0
Ageing 305381 0
Condition category
Condition code
Diet and Nutrition 304665 304665 0 0
Other diet and nutrition disorders
Blood 304666 304666 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Data regarding factors associated with dietary intake and nutrient deficiencies of rest-home level care residents was collected by trained research assistants (RAs) based in each of the participating rest homes (n=16). RAs were final year Master of Dietetic students who had undertaken training in clinical nutrition, food service management, communication and cultural competency. The study dietitian provided specific training for study protocols and operating procedures.

RAs worked with individual participants and care staff regarding the timing of data collection. Assessments were staged over a one week period for each participant so as not to over-burden or fatigue participants.

Data Collected:
- demographic data, physical activity levels, medical history, oral health (oral health impact profile) and medication and dietary supplement use was collected from medical records and discussions with participants and aged-care staff using standardised questionnaires developed specifically for the NZNAPs study.
- mental (geriatric depression scale, clock drawing test and modified mini-mental state examination (3MS) test) and physical function (grip strength and timed walk test) tests were administered using standardised protocols developed for the NZNAPs study.
- anthropometric measurements (weight, ulna length, standing height, waist circumference), were taken according to standardised procedures. Malnutrition screening (mini-nutrition assessment short form) and frailty (SHARE-FI) scores were derived from this data.
- dietary intake data was collected using weighed 3-day diet records. Dietary data was collected over non-consecutive days and included one weekend day. Details of evening snacks were recorded by care staff and any foods and/or beverages consumed away from the rest home were collected using food diaries and interviewer-administered food recalls. Checking of the food diaries and diet recalls occurred as close to the eating period as possible (e.g. if participant out for lunch a review of the food diary/ recall occurred on their return to the aged-care facility that afternoon). Recalls lasted for 5- 15 minutes per eating period.
- fasting blood (collected by trained phlebotomists in a single early morning session) and spot-urine samples (collected by aged-care staff during regular toileting) were used to determine the biochemical nutrition status of participants.
Intervention code [1] 299556 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303878 0
The prevalence of inadequate dietary protein intake (adequate vs inadequate), measured by 3-day weighed food records and compared to the protein Nutrient Reference Values for Australia and New Zealand. All food records were analysed at the conclusion of data collection (April 2015) using Kai-culator dietary analysis software (version 1.1; University of Otago, Dunedin, New Zealand) which matches foods to nutrient lines in the 2010 New Zealand Food Composition Database (Plant & Food Research, New Zealand).
Timepoint [1] 303878 0
Conclusion of data collection
Primary outcome [2] 303879 0
The prevalence of inadequate dietary calcium intake (adequate vs inadequate), measured by 3-day weighed food records and compared to the calcium Nutrient Reference Values for Australia and New Zealand as for primary outcome 1.
Timepoint [2] 303879 0
conclusion of all data collection (April 2015)
Primary outcome [3] 303987 0
The prevalence of inadequate dietary zinc intake (adequate vs inadequate), measured by 3-day weighed food records and compared to the zinc Nutrient Reference Values for Australia and New Zealand as for primary outcome 1.
Timepoint [3] 303987 0
conclusion of all data collection (April 2015)
Secondary outcome [1] 340339 0
Primary outcome: The prevalence of inadequate dietary selenium intake (adequate vs inadequate), measured by 3-day weighed food records and compared to the selenium Nutrient Reference Values for Australia and New Zealand as for primary outcome 1.
Timepoint [1] 340339 0
conclusion of all data collection (April 2015)
Secondary outcome [2] 340340 0
Primary outcome: The prevalence of inadequate dietary iron intake (adequate vs inadequate), measured by 3-day weighed food records and compared to the iron Nutrient Reference Values for Australia and New Zealand as for primary outcome 1.
Timepoint [2] 340340 0
conclusion of all data collection (April 2015)
Secondary outcome [3] 340473 0
The prevalence of inadequate dietary fibre intake (adequate vs inadequate), measured by 3-day weighed food records and compared to the dietary fibre Nutrient Reference Values for Australia and New Zealand as for primary outcome 1.
Timepoint [3] 340473 0
conclusion of all data collection (April 2015)
Secondary outcome [4] 340647 0
Prevalence of iron deficiency by serum assay
- One early morning fasting peripheral venous blood sample

International cut-offs (i.e. the proportion of the cohort with serum values below international cut-offs)
- serum ferritin < 15 ug/L
- sTfR > 8.3 mg/L
- total body iron < 0 mg/kg
Timepoint [4] 340647 0
Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).
Secondary outcome [5] 340648 0
Prevalence of inadequate vitamin D status, (i.e. the proportion of the cohort with serum values below international cut-offs) by serum assay
- One early morning fasting peripheral venous blood sample
- Inadequate vitamin d status defined as serum vitamin D < 50 nmol/L
Timepoint [5] 340648 0
Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).
Secondary outcome [6] 340649 0
Adequacy of iodine status determined from median urinary iodine concentration.
- one casual spot urine sample
- median urinary iodine concentration: range of 20–49 µg/L moderate iodine deficiency; 50–99 µg/L mild deficiency; 100–199 µg/L adequate iodine nutrition
Timepoint [6] 340649 0
casual urine samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).
Secondary outcome [7] 340650 0
Prevalence of inadequate zinc status, (i.e. the proportion of the cohort with serum values below international cut-offs) by serum assay
- One early morning fasting peripheral venous blood sample
- inadequate zinc status defined as plasma zinc < 11.3 µmol/L for men and 10.7 µmol/L for women
Timepoint [7] 340650 0
Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).
Secondary outcome [8] 340651 0
Prevalence of inadequate selenium status, (i.e. the proportion of the cohort with serum values below international cut-offs) by serum assay
- One early morning fasting peripheral venous blood sample
- inadequate selenium status defined as plasma selenium < 0.82 µmol/L (< 65 µg/L)
Timepoint [8] 340651 0
Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).
Secondary outcome [9] 340652 0
Prevalence of anaemia (i.e. the proportion of the cohort with serum haemoglobin values below international cut-offs) by serum assay
- One early morning fasting peripheral venous blood sample
- anaemia defined as haemoglobin <133g/L for men aged 65-69, <124g/L for men aged 70 and older, <120g/L for women aged 65-69 and <118g/L for women aged 70 and older
Timepoint [9] 340652 0
Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).
Secondary outcome [10] 340653 0
Identification of associations between anaemia and health and lifestyle patterns: assessed by logistic regression (adjusted for age and sex) (P < 0.05) (Composite outcome.)
- age, sex, length of stay, health conditions, medications/supplements obtained from clinical records
- frailty (defined by SHARE-FI), malnutrition status (defined by MNA-SF), obesity (defined by BMI) information collected from participants in a single session
- inflammatory markers (hs-CRP, IL-6, AGP) full blood count, plasma zinc and selenium from serum assay
Timepoint [10] 340653 0
analysis occurred November 2016
Secondary outcome [11] 340654 0
Identification of associations between vitamin d status and health and lifestyle patterns: assessed by logistic regression (adjusted for age and sex) (P < 0.05) (Composite outcome.)
- age, sex, length of stay, health conditions, medications/supplements obtained from clinical records
- frailty (defined by SHARE-FI), malnutrition status (defined by MNA-SF), obesity (defined by BMI) information collected from participants
- inflammatory markers (hs-CRP, IL-6, AGP) and 25(OH)D from serum assay
Timepoint [11] 340654 0
analysed February 2016
Secondary outcome [12] 340655 0
Determine the prevalence of Malnutrition risk (defined by the mini-nutrition assessment short form).
Timepoint [12] 340655 0
Malnutrition risk data was collected once only for each participant and analysed at the conclusion of each period of data collection (June 2014 and November 2014).

Eligibility
Key inclusion criteria
residents of NZ aged-care facilities residing at rest-home level care
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
less than 12 weeks residency in a NZ aged-care facility

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/02/2014
Date of last participant enrolment
Anticipated
Actual
19/09/2014
Date of last data collection
Anticipated
Actual
3/10/2014
Sample size
Target
320
Accrual to date
Final
309
Recruitment outside Australia
Country [1] 9337 0
New Zealand
State/province [1] 9337 0

Funding & Sponsors
Funding source category [1] 297912 0
University
Name [1] 297912 0
University of Otago
Country [1] 297912 0
New Zealand
Funding source category [2] 297923 0
Charities/Societies/Foundations
Name [2] 297923 0
Lottery Health Research
Country [2] 297923 0
New Zealand
Funding source category [3] 297924 0
Charities/Societies/Foundations
Name [3] 297924 0
Maurice and Phyllis Paykel Trust
Country [3] 297924 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Lisa Houghton
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 296985 0
None
Name [1] 296985 0
Address [1] 296985 0
Country [1] 296985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298962 0
Uiversity of Otago Human Ethics Committee
Ethics committee address [1] 298962 0
Ethics committee country [1] 298962 0
New Zealand
Date submitted for ethics approval [1] 298962 0
02/12/2013
Approval date [1] 298962 0
06/01/2014
Ethics approval number [1] 298962 0
H13/118

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78806 0
A/Prof Lisa Houghton
Address 78806 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 78806 0
New Zealand
Phone 78806 0
+64 3 479 7294
Fax 78806 0
Email 78806 0
[email protected]
Contact person for public queries
Name 78807 0
Sue MacDonell
Address 78807 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 78807 0
New Zealand
Phone 78807 0
+64 21 422 119
Fax 78807 0
Email 78807 0
[email protected]
Contact person for scientific queries
Name 78808 0
Sue MacDonell
Address 78808 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 78808 0
New Zealand
Phone 78808 0
+64 21 422 119
Fax 78808 0
Email 78808 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
SourceTitleYear of PublicationDOI
EmbaseMultiple micronutrients, including zinc, selenium and iron, are positively associated with anemia in New Zealand aged care residents.2021https://dx.doi.org/10.3390/nu13041072
N.B. These documents automatically identified may not have been verified by the study sponsor.