Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults
Primary Purpose
Aging, Age Problem, Age-related Cognitive Decline
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Dietary Counselling
Sponsored by
About this trial
This is an interventional supportive care trial for Aging focused on measuring Older adults, Dietary consultation, Mental health, Sleep quality, Dietary quality, Cardio-metabolic health
Eligibility Criteria
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
Sites / Locations
- National University of Singapaore
- Hannah Senior Activity CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary Counselling
No Dietary Counselling
Arm Description
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.
Subjects in the control group will be followed for 24-weeks without any dietary counselling.
Outcomes
Primary Outcome Measures
Change in diet
Dietary assessment, 3-day food record (participant)
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)
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.
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)
Secondary Outcome Measures
Change in diet
Dietary Assessment, 3-day food record (Participant's family member)
Change in weight
Weight (kg)
Change in waist circumference
Waist Circumference (cm)
Change in blood pressure
Systolic and diastolic blood pressure (mmHg) after a 10 hour overnight fast
Change in total cholesterol
Total cholesterol (mmol/l)
Change in high-density lipoprotein cholesterol
High-density lipoprotein cholesterol (mmol/l)
Change in low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol (mmol/l)
Change in total triglyceride
Total triglyceride (mmol/l)
Change in blood glucose concentration
Blood glucose concentration
Change in blood insulin concentration
Blood insulin concentration
Change in daily physical activity
Tracked with an electronic activity tracker
Full Information
NCT ID
NCT03702335
First Posted
October 5, 2018
Last Updated
September 1, 2021
Sponsor
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03702335
Brief Title
Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults
Official Title
Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Age Problem, Age-related Cognitive Decline, Age-Related Atrophy
Keywords
Older adults, Dietary consultation, Mental health, Sleep quality, Dietary quality, Cardio-metabolic health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary Counselling
Arm Type
Experimental
Arm Description
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.
Arm Title
No Dietary Counselling
Arm Type
No Intervention
Arm Description
Subjects in the control group will be followed for 24-weeks without any dietary counselling.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in diet
Description
Dietary assessment, 3-day food record (participant)
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)
Title
Change in mental health status
Description
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)
Time Frame
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Title
Change in quality of life
Description
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.
Time Frame
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Title
Change in sleep quality
Description
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)
Time Frame
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary Outcome Measure Information:
Title
Change in diet
Description
Dietary Assessment, 3-day food record (Participant's family member)
Time Frame
Every 12 weeks (Week 0, week 12 and week 24)
Title
Change in weight
Description
Weight (kg)
Time Frame
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Title
Change in waist circumference
Description
Waist Circumference (cm)
Time Frame
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Title
Change in blood pressure
Description
Systolic and diastolic blood pressure (mmHg) after a 10 hour overnight fast
Time Frame
Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Title
Change in total cholesterol
Description
Total cholesterol (mmol/l)
Time Frame
Every 12 weeks (Week 0, week 12, and week 24)
Title
Change in high-density lipoprotein cholesterol
Description
High-density lipoprotein cholesterol (mmol/l)
Time Frame
Every 12 weeks (Week 0, week 12, and week 24)
Title
Change in low-density lipoprotein cholesterol
Description
Low-density lipoprotein cholesterol (mmol/l)
Time Frame
Every 12 weeks (Week 0, week 12, and week 24)
Title
Change in total triglyceride
Description
Total triglyceride (mmol/l)
Time Frame
Every 12 weeks (Week 0, week 12, and week 24)
Title
Change in blood glucose concentration
Description
Blood glucose concentration
Time Frame
Every 12 weeks (Week 0, week 12, and week 24)
Title
Change in blood insulin concentration
Description
Blood insulin concentration
Time Frame
Every 12 weeks (Week 0, week 12, and week 24)
Title
Change in daily physical activity
Description
Tracked with an electronic activity tracker
Time Frame
Daily (Week 0 to week 24)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Eun Kim, PhD, RD
Phone
65161136
Ext
65
Email
fstkje@nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmine Low, BSc (Hons)
Phone
94510860
Ext
65
Email
jasmine.low@u.nus.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Eun Kim, PhD, RD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Singapaore
City
Singapore
ZIP/Postal Code
117546
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Hannah Senior Activity Centre
City
Singapore
ZIP/Postal Code
590021
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Low, BSc (Hons)
Phone
+6594510860
Email
jasmine.low@u.nus.edu
First Name & Middle Initial & Last Name & Degree
Jung Eun Kim, PhD, RD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29215971
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 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.
Results Reference
result
PubMed Identifier
27476869
Citation
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.
Results Reference
result
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Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults
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