- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702335
Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jung Eun Kim, PhD, RD
- Phone Number: 65 65161136
- Email: fstkje@nus.edu.sg
Study Contact Backup
- Name: Jasmine Low, BSc (Hons)
- Phone Number: 65 94510860
- Email: jasmine.low@u.nus.edu
Study Locations
-
-
-
Singapore, Singapore, 117546
- Active, not recruiting
- National University of Singapaore
-
Singapore, Singapore, 590021
- Recruiting
- Hannah Senior Activity Centre
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Contact:
- Jasmine Low, BSc (Hons)
- Phone Number: +6594510860
- Email: jasmine.low@u.nus.edu
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Principal Investigator:
- Jung Eun Kim, PhD, RD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dietary Counselling
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.
|
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.
|
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No Intervention: No Dietary Counselling
Subjects in the control group will be followed for 24-weeks without any dietary counselling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Dietary assessment, 3-day food record (participant)
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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
Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
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)
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Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
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Change in quality of life
Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
Quality of Life Questionnaire
|
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
|
Change in sleep quality
Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in diet
Time Frame: Every 12 weeks (Week 0, week 12 and week 24)
|
Dietary Assessment, 3-day food record (Participant's family member)
|
Every 12 weeks (Week 0, week 12 and week 24)
|
|
Change in weight
Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
Weight (kg)
|
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
|
Change in waist circumference
Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
Waist Circumference (cm)
|
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
|
Change in blood pressure
Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
Systolic and diastolic blood pressure (mmHg) after a 10 hour overnight fast
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Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
|
|
Change in total cholesterol
Time Frame: Every 12 weeks (Week 0, week 12, and week 24)
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Total cholesterol (mmol/l)
|
Every 12 weeks (Week 0, week 12, and week 24)
|
|
Change in high-density lipoprotein cholesterol
Time Frame: Every 12 weeks (Week 0, week 12, and week 24)
|
High-density lipoprotein cholesterol (mmol/l)
|
Every 12 weeks (Week 0, week 12, and week 24)
|
|
Change in low-density lipoprotein cholesterol
Time Frame: Every 12 weeks (Week 0, week 12, and week 24)
|
Low-density lipoprotein cholesterol (mmol/l)
|
Every 12 weeks (Week 0, week 12, and week 24)
|
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Change in total triglyceride
Time Frame: Every 12 weeks (Week 0, week 12, and week 24)
|
Total triglyceride (mmol/l)
|
Every 12 weeks (Week 0, week 12, and week 24)
|
|
Change in blood glucose concentration
Time Frame: Every 12 weeks (Week 0, week 12, and week 24)
|
Blood glucose concentration
|
Every 12 weeks (Week 0, week 12, and week 24)
|
|
Change in blood insulin concentration
Time Frame: Every 12 weeks (Week 0, week 12, and week 24)
|
Blood insulin concentration
|
Every 12 weeks (Week 0, week 12, and week 24)
|
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Change in daily physical activity
Time Frame: Daily (Week 0 to week 24)
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Tracked with an electronic activity tracker
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Daily (Week 0 to week 24)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jung Eun Kim, PhD, RD, National University of Singapore
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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