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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03702335
• Other study ID #: S3
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: November 2021

Study information

• Verified date: September 2021
• Source: National University, Singapore
• Contact: Jung Eun Kim, PhD, RD
• Phone: 65161136
• Email: fstkje[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Able to give an informed consent

2. Age =60 years

3. No weight change >3kg in the past 3 months

4. Not exercising vigorously over the past 3 months

5. Does not have any intestinal disorders, including lactose intolerance

6. No acute illness

7. Non-smoker

8. Non-vegetarian

9. Not drinking more than 2 alcoholic drinks/day

10. Not taking any lipid-lowering and blood pressure controlling medications less than 3 years

Exclusion Criteria:

1. Unable to give an informed consent

2. Age < 60 years

3. Weight change >3kg in the past 3 months

4. Exercises vigorously over the past 3 months

5. Have intestinal disorders, including lactose intolerence

6. Having acute illness

7. Smoking

8. Vegetarian

9. Drinking more than 2 alcoholic drinks/day

10. Taking lipid-lowering and blood pressure controlling medications less than 3 years

Related Conditions & MeSH terms

• Age Problem
• Age-Related Atrophy
• Age-related Cognitive Decline
• Aging
• Atrophy
• Cognitive Dysfunction

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Singapore	Hannah Senior Activity Centre	Singapore
Singapore	National University of Singapaore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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: — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in diet	Dietary Assessment, 3-day food record (Participant's family member)	Every 12 weeks (Week 0, week 12 and week 24)
Secondary	Change in weight	Weight (kg)	Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary	Change in waist circumference	Waist Circumference (cm)	Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary	Change in blood pressure	Systolic and diastolic blood pressure (mmHg) after a 10 hour overnight fast	Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary	Change in total cholesterol	Total cholesterol (mmol/l)	Every 12 weeks (Week 0, week 12, and week 24)
Secondary	Change in high-density lipoprotein cholesterol	High-density lipoprotein cholesterol (mmol/l)	Every 12 weeks (Week 0, week 12, and week 24)
Secondary	Change in low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol (mmol/l)	Every 12 weeks (Week 0, week 12, and week 24)
Secondary	Change in total triglyceride	Total triglyceride (mmol/l)	Every 12 weeks (Week 0, week 12, and week 24)
Secondary	Change in blood glucose concentration	Blood glucose concentration	Every 12 weeks (Week 0, week 12, and week 24)
Secondary	Change in blood insulin concentration	Blood insulin concentration	Every 12 weeks (Week 0, week 12, and week 24)
Secondary	Change in daily physical activity	Tracked with an electronic activity tracker	Daily (Week 0 to week 24)