跳至主要内容
临床试验/NCT03702335
NCT03702335Unknown不适用

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

National University of Singapore4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
4
主要终点
Change in diet

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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-vegetarian
  • Not drinking more than 2 alcoholic drinks/day
  • Not taking any lipid-lowering and blood pressure controlling medications less than 3 years

排除标准

  • 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
  • Drinking more than 2 alcoholic drinks/day
  • Taking lipid-lowering and blood pressure controlling medications less than 3 years

结局指标

主要结局

Change in diet

时间窗: 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)

Change in quality of life

时间窗: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24)

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 mental health status

时间窗: 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)

Change in sleep quality

时间窗: 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)

次要结局

  • Change in waist circumference(Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24))
  • Change in weight(Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24))
  • Change in total cholesterol(Every 12 weeks (Week 0, week 12, and week 24))
  • Change in diet(Every 12 weeks (Week 0, week 12 and week 24))
  • Change in blood pressure(Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24))
  • Change in high-density lipoprotein cholesterol(Every 12 weeks (Week 0, week 12, and week 24))
  • Change in low-density lipoprotein cholesterol(Every 12 weeks (Week 0, week 12, and week 24))
  • Change in total triglyceride(Every 12 weeks (Week 0, week 12, and week 24))
  • Change in blood glucose concentration(Every 12 weeks (Week 0, week 12, and week 24))
  • Change in blood insulin concentration(Every 12 weeks (Week 0, week 12, and week 24))
  • Change in daily physical activity(Daily (Week 0 to week 24))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung Eun Kim

Assistant Professor

National University of Singapore

研究点 (4)

Loading locations...

相似试验

Impact of Comprehensive Dietary Counseling on... | 临床试验