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Trial record 40 of 229 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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ClinicalTrials.gov Identifier: NCT03702335
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Jung Eun Kim, National University, Singapore

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.


Condition or disease Intervention/treatment Phase
Aging Age Problem Age-related Cognitive Decline Age-Related Atrophy Behavioral: Dietary Counselling Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Dietary Counselling
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
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.

No Intervention: No Dietary Counselling
Subjects in the control group will be followed for 24-weeks without any dietary counselling.



Primary Outcome Measures :
  1. Change in diet [ 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) ]
    Dietary assessment, 3-day food record (participant)

  2. Change in mental health status [ Time Frame: 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)

  3. Change in quality of life [ Time Frame: 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.

  4. Change in sleep quality [ Time Frame: 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)


Secondary Outcome Measures :
  1. Change in diet [ Time Frame: Every 12 weeks (Week 0, week 12 and week 24) ]
    Dietary Assessment, 3-day food record (Participant's family member)

  2. Change in weight [ Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24) ]
    Weight (kg)

  3. Change in waist circumference [ Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24) ]
    Waist Circumference (cm)

  4. Change in blood pressure [ Time Frame: Every 4 weeks (Week 0, week 4, week 8, week 12, week 16, week 20 and week 24) ]
    Systolic and diastolic blood pressure (mmHg) after a 10 hour overnight fast

  5. Change in total cholesterol [ Time Frame: Every 12 weeks (Week 0, week 12, and week 24) ]
    Total cholesterol (mmol/l)

  6. Change in high-density lipoprotein cholesterol [ Time Frame: Every 12 weeks (Week 0, week 12, and week 24) ]
    High-density lipoprotein cholesterol (mmol/l)

  7. Change in low-density lipoprotein cholesterol [ Time Frame: Every 12 weeks (Week 0, week 12, and week 24) ]
    Low-density lipoprotein cholesterol (mmol/l)

  8. Change in total triglyceride [ Time Frame: Every 12 weeks (Week 0, week 12, and week 24) ]
    Total triglyceride (mmol/l)

  9. Change in blood glucose concentration [ Time Frame: Every 12 weeks (Week 0, week 12, and week 24) ]
    Blood glucose concentration

  10. Change in blood insulin concentration [ Time Frame: Every 12 weeks (Week 0, week 12, and week 24) ]
    Blood insulin concentration

  11. Change in daily physical activity [ Time Frame: Daily (Week 0 to week 24) ]
    Tracked with an electronic activity tracker



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702335


Contacts
Contact: Jung Eun Kim, PhD, RD 65161136 ext 65 chmkje@nus.edu.sg
Contact: Jasmine Low, BSc (Hons) 94510860 ext 65 jasmine.low@u.nus.edu

Locations
Singapore
National University of Singapaore
Singapore, Singapore, 117546
Hannah Senior Activity Centre
Singapore, Singapore, 590021
Sponsors and Collaborators
National University, Singapore
Investigators
Principal Investigator: Jung Eun Kim, PhD, RD National University, Singapore

Publications of Results:
Responsible Party: Jung Eun Kim, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT03702335     History of Changes
Other Study ID Numbers: S3
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jung Eun Kim, National University, Singapore:
Older adults
Dietary consultation
Mental health
Sleep quality
Dietary quality
Cardio-metabolic health

Additional relevant MeSH terms:
Atrophy
Cognitive Dysfunction
Pathological Conditions, Anatomical
Cognition Disorders
Neurocognitive Disorders
Mental Disorders