Clinical trial NCT03702335: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Age Problem
Age-related Cognitive Decline
Age-Related Atrophy
Keywords: Older adults
Dietary consultation
Mental health
Sleep quality
Dietary quality
Cardio-metabolic health
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in diet
timeFrame: 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)
measure: Change in mental health status
timeFrame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
measure: Change in quality of life
timeFrame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
measure: Change in sleep quality
timeFrame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary outcomes:
measure: Change in diet
timeFrame: Every 12 weeks (Week 0, week 12 and week 24)
measure: Change in weight
timeFrame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
measure: Change in waist circumference
timeFrame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
measure: Change in blood pressure
timeFrame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)
measure: Change in total cholesterol
timeFrame: Every 12 weeks (Week 0, week 12, and week 24)
measure: Change in high-density lipoprotein cholesterol
timeFrame: Every 12 weeks (Week 0, week 12, and week 24)
measure: Change in low-density lipoprotein cholesterol
timeFrame: Every 12 weeks (Week 0, week 12, and week 24)
measure: Change in total triglyceride
timeFrame: Every 12 weeks (Week 0, week 12, and week 24)
measure: Change in blood glucose concentration
timeFrame: Every 12 weeks (Week 0, week 12, and week 24)
measure: Change in blood insulin concentration
timeFrame: Every 12 weeks (Week 0, week 12, and week 24)
measure: Change in daily physical activity
timeFrame: Daily (Week 0 to week 24)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapaore
city: Singapore
country: Singapore
facility: Hannah Senior Activity Centre
Study officials:
affiliation: National University of Singapore
name: Jung Eun Kim, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.