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

Study Overview
=================
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.

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

Conditions
-----------------
Aging, Age Problem, Age-related Cognitive Decline, Age-Related Atrophy

Intervention / Treatment
-----------------
* Behavioral: Dietary Counselling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Counselling<br>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<br>* 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.<br>|
| No Intervention: No Dietary Counselling<br>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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diet | Dietary Assessment, 3-day food record (Participant's family member) | Every 12 weeks (Week 0, week 12 and week 24) | 
| Change in weight | Weight (kg) | Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24) | 
| 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) | 
| 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) | 
| Change in total cholesterol | Total cholesterol (mmol/l) | Every 12 weeks (Week 0, week 12, and week 24) | 
| Change in high-density lipoprotein cholesterol | High-density lipoprotein cholesterol (mmol/l) | Every 12 weeks (Week 0, week 12, and week 24) | 
| Change in low-density lipoprotein cholesterol | Low-density lipoprotein cholesterol (mmol/l) | Every 12 weeks (Week 0, week 12, and week 24) | 
| Change in total triglyceride | Total triglyceride (mmol/l) | Every 12 weeks (Week 0, week 12, and week 24) | 
| Change in blood glucose concentration | Blood glucose concentration | Every 12 weeks (Week 0, week 12, and week 24) | 
| Change in blood insulin concentration | Blood insulin concentration | Every 12 weeks (Week 0, week 12, and week 24) | 
| Change in daily physical activity | Tracked with an electronic activity tracker | Daily (Week 0 to week 24) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Older adults, Dietary consultation, Mental health, Sleep quality, Dietary quality, Cardio-metabolic health