AzTrials
AzTrials

AgingNCT03702335

Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults

A study testing Dietary Counselling in people with Aging and Age Problem, run by National University of Singapore at 2 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Aging, Age Problem, Age-related Cognitive Decline
What is being tested?
Dietary Counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesSingapore
Study dates
13 Nov 2018to Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Smoking
  • Vegetarian
  • Drinking more than 2 alcoholic drinks/day
  • Taking lipid-lowering and blood pressure controlling medications less than 3 years

Trial locations and contacts

2 sites in 1 country.

Jung Eun Kim, PhD, RD contact

65161136 ext. 65

fstkje@nus.edu.sg

Jasmine Low, BSc (Hons) contact

94510860 ext. 65

jasmine.low@u.nus.edu

Singapore2 sites, 1 recruiting

  • National University of Singapaore

    Singapore, 117546

    Active, not recruiting

  • Hannah Senior Activity Centre

    Singapore, 590021

    Jasmine Low, BSc (Hons), +6594510860, jasmine.low@u.nus.edu

    Jung Eun Kim, PhD, RD

    Recruiting

Other trials in Singapore

About this study

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.

Read the detailed description

Fifty female Chinese older adults (aged 60+y) will be recruited with the expectation that ≥ 40 subjects will complete the study. This is a 24-wk parallel, single-bind, prospective study design with subjects randomly assigned to either receiving comprehensive dietary counselling (intervention group) or not receiving comprehensive dietary counselling (control group). Subjects in the intervention group will only receive comprehensive dietary counselling for first 12-wk and then they will be followed for another 12-wk without comprehensive dietary counselling. Subjects in the control group will be followed for 24-wk without any intervention. Dietary quality, mental health, sleep quality, daily physical activity and quality of life will be assessed and blood lipid-lipoproteins, glucose and insulin concentrations will be measured from the collected blood samples.

Being tested
Dietary Counselling
Keywords
Older adults, Dietary consultation, Mental health, Sleep quality, Dietary quality, Cardio-metabolic health
Medical subject headings
Psychological Well-Being, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary CounsellingBehavioural

    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.

Study groups in NCT03702335
Study groupRoleWhat they receive
Dietary CounsellingExperimentalEach 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.
Receives: Behavioral: Dietary Counselling
No Dietary CounsellingNo interventionSubjects in the control group will be followed for 24-weeks without any dietary counselling.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in diet

    Dietary assessment, 3-day food record (participant)

    Measured: 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)

  2. 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)

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

  3. 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.

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

  4. 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)

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

Secondary outcomes (11)

  1. Change in diet

    Dietary Assessment, 3-day food record (Participant's family member)

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

  2. Change in weight

    Weight (kg)

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

  3. Change in waist circumference

    Waist Circumference (cm)

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

  4. Change in blood pressure

    Systolic and diastolic blood pressure (mmHg) after a 10 hour overnight fast

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

  5. Change in total cholesterol

    Total cholesterol (mmol/l)

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

  6. Change in high-density lipoprotein cholesterol

    High-density lipoprotein cholesterol (mmol/l)

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

  7. Change in low-density lipoprotein cholesterol

    Low-density lipoprotein cholesterol (mmol/l)

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

  8. Change in total triglyceride

    Total triglyceride (mmol/l)

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

  9. Change in blood glucose concentration

    Blood glucose concentration

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

  10. Change in blood insulin concentration

    Blood insulin concentration

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

  11. Change in daily physical activity

    Tracked with an electronic activity tracker

    Measured: Daily (Week 0 to week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2018
  2. Study start13 Nov 2018
  3. Primary completionSep 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03702335
Sponsor's protocol ID
S3
Status last verified
Sep 2021
First submitted
5 Oct 2018
Last updated
2 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29215971

  • 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.

    PubMed 27476869

  • 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. 2026 May;36(5):104536. doi: 10.1016/j.numecd.2025.104536. Epub 2025 Dec 24.

    PubMed 41622098

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Counselling in people with Aging and Age Problem, run by National University of Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jung Eun Kim, PhD, RD (65161136 ext. 65, fstkje@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in diet (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03702335, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.

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