NCT03240952

Brief Summary

Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient requirements concomitant with a reduction in energy requirements, decreases in appetite and energy intake. Currently there is a gap in knowledge of the factors that are associated with malnutrition in the elderly in Singapore. In addition, there is no "reference" database on anthropometric measurements and biochemical indices for elderly with a range of nutrition status in Singapore. Thus, the objectives of this cross-sectional study are to examine factors influencing nutritional status and to determine the reference values for anthropometric and biochemical measurements related to nutritional status for community-dwelling elderly in Singapore.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

August 1, 2017

Last Update Submit

April 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • MUST

    Malnutrition risk using Malnutrition Universal Screening Tool

    Baseline

Secondary Outcomes (3)

  • Body weight, fat mass, fat free mass

    Baseline

  • Pre-albumin

    Baseline

  • Albumin and total protein

    Baseline

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This cross-sectional study will include 400 elderly with normal nutrition (MUST score: 0) and 800 elderly who are at risk of undernutrition (MUST score ≥ 1). Community-dwelling elderly recently discharged from the hospital as well as those who recently visited polyclinics in Singapore will be recruited for the study.

You may qualify if:

  • Male or female participant aged ≥65 years.
  • Community-dweller, i.e. not staying in a residential intermediate and long-term care (ILTC) service institution.
  • Participant is being discharged home directly (applicable for hospital cohort).
  • Participant is community ambulant with or without aid.
  • Participant does not have any chronic disease(s) or has stable chronic disease(s) including hypertension, chronic obstructive pulmonary disease, and cardiovascular disease in the opinion of the Study Physician, at study entry.
  • Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board (IRB) and provided authorization prior to any participation in the study.
  • Participants will be able to communicate and follow instructions.
  • Participant is able to consume food and beverages orally.

You may not qualify if:

  • Participant has been diagnosed with dementia according to medical records.
  • Participant has been diagnosed with type 1 or type 2 diabetes according to medical records. (Note: This includes participant with controlled diabetes.)
  • Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection) according to medical records.
  • Participant has been diagnosed with severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records.
  • Participant has been diagnosed with end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the screening according to medical records.
  • Participant has malignancy according to medical records.
  • Participant is taking part in another study that has not been approved as a concomitant study by the study team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Marine Parade Polyclinic

Singapore, 440080, Singapore

Location

Bedok Polyclinic

Singapore, 460212, Singapore

Location

Tampines Polyclinic

Singapore, 529203, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

  • Ong RHS, Chow WL, Cheong M, Lim GH, Xie W, Baggs G, Huynh DTT, Oh HC, How CH, Tan NC, Tey SL, Chew STH. Associations between socio-demographics, nutrition knowledge, nutrition competencies and attitudes in community-dwelling healthy older adults in Singapore: findings from the SHIELD study. J Health Popul Nutr. 2021 Dec 11;40(1):52. doi: 10.1186/s41043-021-00277-4.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Siew Ling Tey, Ph.D.

    Abbott Nutrition Research & Development

    STUDY CHAIR
  • Samuel TH Chew, MB.BCh.BAO

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 7, 2017

Study Start

August 30, 2017

Primary Completion

May 28, 2018

Study Completion

July 26, 2018

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations