ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

NZNAPs

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Nutrition Status

Ageing

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Blood

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Conclusion of data collection

Primary outcome [2]

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]

conclusion of all data collection (April 2015)

Primary outcome [3]

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]

conclusion of all data collection (April 2015)

Secondary outcome [1]

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]

conclusion of all data collection (April 2015)

Secondary outcome [2]

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]

conclusion of all data collection (April 2015)

Secondary outcome [3]

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]

conclusion of all data collection (April 2015)

Secondary outcome [4]

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]

Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).

Secondary outcome [5]

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]

Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).

Secondary outcome [6]

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]

casual urine samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).

Secondary outcome [7]

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]

Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).

Secondary outcome [8]

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]

Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).

Secondary outcome [9]

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]

Fasting blood samples were collected once/participant and analysed at the conclusion of all data collection (April 2015).

Secondary outcome [10]

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]

analysis occurred November 2016

Secondary outcome [11]

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]

analysed February 2016

Secondary outcome [12]

Determine the prevalence of Malnutrition risk (defined by the mini-nutrition assessment short form).

Timepoint [12]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO BOX 56
Dunedin 9054
New Zealand

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Lottery Health Research

Address [2]

Department of Internal Affairs
PO Box 805
WELLINGTON 6140

Country [2]

New Zealand

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Maurice and Phyllis Paykel Trust

Address [3]

PO Box 110008
Auckland Hospital
Auckland 1148

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Uiversity of Otago Human Ethics Committee

Ethics committee address [1]

PO BOX 56
Dunedin 9054
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

02/12/2013

Approval date [1]

06/01/2014

Ethics approval number [1]

H13/118

Summary

Brief summary

This project will collect information on the dietary intakes and nutritional status of New Zealanders residing in aged-care rest homes, in order to inform the development of safe and appropriate strategies to improve the health of these residents.
Poor nutrition in older adults is a major cause of ill health and reduced quality of life.  Undernourished elderly have more frequent and longer hospital visits and higher risk of progressing to nursing home care. Studies across Australia, Europe and UK show that poor nutrient intake is common in rest homes, affecting 35%-85% of residents. However, there is little information on the nutritional status of residents in rest homes in NZ.
We will examine dietary intakes and blood levels of iron; selenium; zinc; vitamins D, B12, B6 and folate. We will also examine levels of iodine and sodium (salt) in urine. These nutrients are known to be low in the diets of independent-living older New Zealanders, and low intakes are associated with ill health and disability. We will determine the prevalence of nutrition-related health conditions (e.g. anaemia, frailty, poor oral health), and investigate health and lifestyle patterns that may lead to nutrient deficiencies.

Trial website

Trial related presentations / publications

1.	MacDonell, SO, Miller, JC, Harper, MJ, Reid, MR, Haszard, JJ, Gibson, RS, & Houghton, LA. (2017). Multiple micronutrient deficiencies exist in aged-care residents, with serum zinc, not iron, being a major predictor of anemia. FASEB Journal, 31(1 Suppl), 460.2. [Abstract].

2.	MacDonell SO, Miller JC, Harper MJ, Waters DL, Houghton LA. Vitamin D status and its predictors in New Zealand aged-care residents eligible for a government-funded universal vitamin D supplementation programme. Public Health Nutrition 2016:1-12. doi: 10.1017/S1368980016001683.

3.	Miller J, MacDonell S, Gray A, Reid M, Barr D, Thomson C, Houghton L. Iodine Status of New Zealand Elderly Residents in Long-Term Residential Care. Nutrients 2016;8(8):445.

4.	MacDonell SO, Miller JC, Harper MJ, Haszard JJ, Gibson RS, Waters DL, Houghton LA. Biochemical micronutrient status of New Zealand aged-care residents. (2017). Oral free paper presentation at Dietitians New Zealand National Professional Development Meeting, Wellington, NZ. September 2017.

5.	MacDonell S, Miller J, Gibson RS, Haszard JJ, Houghton LA. Multiple micronutrient deficiencies exist in rest-home level aged care residents with serum zinc, not iron being a major predictor of anemia. Poster presentation (Emerging Leaders Poster Competition) at 2017 Experimental Biology Annual Meeting, Chicago, IL, USA. April 2017

6.	Miller JC, MacDonell SO, Houghton LA. (2014). Nutrient intakes of rest-home level residents in New Zealand aged care facilities: preliminary findings. Invited oral presentation (J Miller) at 2014 New Zealand Institute of Food Science and Technology Conference, Christchurch, NZ. July 2014

Public notes

Contacts

Principal investigator

Name

A/Prof Lisa Houghton

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 3 479 7294

Fax

lisa.houghton@otago.ac.nz

Contact person for public queries

Name

Sue MacDonell

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 21 422 119

Fax

sue.macdonell@otago.ac.nz

Contact person for scientific queries

Name

Sue MacDonell

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 21 422 119

Fax

sue.macdonell@otago.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	Multiple micronutrients, including zinc, selenium and iron, are positively associated with anemia in New Zealand aged care residents.	2021	https://dx.doi.org/10.3390/nu13041072

N.B. These documents automatically identified may not have been verified by the study sponsor.

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