NCT03702335

Brief Summary

As a person ages, an incidence of mental distress such as depression and anxiety increases while the quality of life decreases. Singapore's population is aging rapidly and older adults may suffer from mental distress and deteriorated quality of life. Recent evidence suggests that good nutrition is essential for mental health and quality of life in older adults. Previous research reported that provision of nutrition education and cooking workshops to people with mental illness for 3 months achieved healthy dietary change and improved mental health. This proposed study aims to further assess the effect of comprehensive dietary counselling on dietary quality, cardio-metabolic, mental health, sleep quality, and quality of life through a 24-wk parallel intervention study in Singapore older adults. The investigators hypothesised that older adults who receive comprehensive dietary counselling will improve dietary quality, cardio-metabolic health, mental health, sleep quality, and quality of life when compared to older adults who do not receive comprehensive dietary counselling.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

October 5, 2018

Last Update Submit

September 1, 2021

Conditions

Keywords

Older adultsDietary consultationMental healthSleep qualityDietary qualityCardio-metabolic health

Outcome Measures

Primary Outcomes (4)

  • Change in diet

    Dietary assessment, 3-day food record (participant)

    Every 2 week for the first 12 weeks and every 4 weeks for the last 12 weeks (Week 0, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24)

  • Change in mental health status

    Mental Health Questionnaire - Consisting of basic health screen recording anthropometric measurements, visual functioning questionnaire scale (1; Good, 2; Acceptable, 3; Poor), Lifestyle (0; Never, 1; 1-3 times/month, 2; 1-3 times/week, 3; 4-6 times/week, 4; daily), depression scale (Yes or no questionnaire)

    Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)

  • Change in quality of life

    Quality of Life Questionnaire * Subjective scale rating (1; very dissatisfied, 2; dissatisfied, 3; neither satisfied not dissatisfied, 4; satisfied, 5; very satisfied) assessing quality of life, health and other areas of life.

    Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)

  • Change in sleep quality

    Pittsburgh Sleep Quality Assessment (PSQI) - Recall based questionnaire assessing sleep habits for the past one month only which includes sleeping timing habits and quality of sleep (Very good, Fairly good, Fairly bad and very bad)

    Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)

Secondary Outcomes (11)

  • Change in diet

    Every 12 weeks (Week 0, week 12 and week 24)

  • Change in weight

    Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)

  • Change in waist circumference

    Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)

  • Change in blood pressure

    Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)

  • Change in total cholesterol

    Every 12 weeks (Week 0, week 12, and week 24)

  • +6 more secondary outcomes

Study Arms (2)

Dietary Counselling

EXPERIMENTAL

Each subject will receive a comprehensive dietary counselling for the first 12-weeks of the study, which will be followed by another 12-weeks without dietary counselling.

Behavioral: Dietary Counselling

No Dietary Counselling

NO INTERVENTION

Subjects in the control group will be followed for 24-weeks without any dietary counselling.

Interventions

Intervention group will be given a comprehensive dietary guidance on how to choose healthier options when eating out, as well as how to personally prepare a healthy meals.

Dietary Counselling

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give an informed consent
  • Age ≥60 years
  • No weight change \>3kg in the past 3 months
  • Not exercising vigorously over the past 3 months
  • Does not have any intestinal disorders, including lactose intolerance
  • No acute illness
  • Non-smoker
  • Non-vegetarian
  • Not drinking more than 2 alcoholic drinks/day
  • Not taking any lipid-lowering and blood pressure controlling medications less than 3 years

You may not qualify if:

  • Unable to give an informed consent
  • Age \< 60 years
  • Weight change \>3kg in the past 3 months
  • Exercises vigorously over the past 3 months
  • Have intestinal disorders, including lactose intolerence
  • Having acute illness
  • Smoking
  • Vegetarian
  • Drinking more than 2 alcoholic drinks/day
  • Taking lipid-lowering and blood pressure controlling medications less than 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University of Singapaore

Singapore, 117546, Singapore

ACTIVE NOT RECRUITING

Hannah Senior Activity Centre

Singapore, 590021, Singapore

RECRUITING

Related Publications (3)

  • Parletta N, Zarnowiecki D, Cho J, Wilson A, Bogomolova S, Villani A, Itsiopoulos C, Niyonsenga T, Blunden S, Meyer B, Segal L, Baune BT, O'Dea K. A Mediterranean-style dietary intervention supplemented with fish oil improves diet quality and mental health in people with depression: A randomized controlled trial (HELFIMED). Nutr Neurosci. 2019 Jul;22(7):474-487. doi: 10.1080/1028415X.2017.1411320. Epub 2017 Dec 7.

  • Bogomolova S, Zarnowiecki D, Wilson A, Fielder A, Procter N, Itsiopoulos C, O'Dea K, Strachan J, Ballestrin M, Champion A, Parletta N. Dietary intervention for people with mental illness in South Australia. Health Promot Int. 2018 Feb 1;33(1):71-83. doi: 10.1093/heapro/daw055.

  • Ting M, Low JHM, Lee DPS, Fam J, Mahendran R, Kua EH, Kim JE. Impact of dietary counselling on cardiometabolic health, mental health and dietary quality in Singapore older women. Nutr Metab Cardiovasc Dis. 2025 Dec 24:104536. doi: 10.1016/j.numecd.2025.104536. Online ahead of print.

MeSH Terms

Conditions

Psychological Well-BeingSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jung Eun Kim, PhD, RD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Eun Kim, PhD, RD

CONTACT

Jasmine Low, BSc (Hons)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 11, 2018

Study Start

November 13, 2018

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations