Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

Sponsor
Taipei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05092087
Collaborator
(none)
129
1
1.3
98.2

Study Details

Study Description

Brief Summary

This study aims to investigate the frequency of personalized nutrition counseling's effect on individual cardiovascular risk factors. The study collected 110 to 150 cases data, including a regular blood test, blood glucose, blood lipid, liver panel, and inflammatory factors. The enrolled cases were classified into two groups according to the subjects' duration of consultation: those who completed the consultation and subsequent tests in >24 weeks were in the control group, whereas those who completed the consultation and subsequent tests in <24 weeks were in the test group. The effectiveness of nutrition consultation toward managing cardiovascular disease risk factors and its correlation with the subjects' frequency of following the consultations was analyzed using the pre- and post-consultation data. It was found that personalized nutrition consultation significantly improved the subjects' risk factors of cardiovascular diseases, and that the treatment group showed a greater improvement than the control group which who require over 24 weeks to complete all consultation sessions.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: nutrition counseling

Detailed Description

The most of interventional studies on nutrition consultation have generally emphasized on the extent to which the diet composition can prevent chronic diseases or provide improvement. Although dietitians play an important role in health education for the primary prevention of chronic disease, their individuals dietary consultation results are mostly focused on weight loss and blood glucose control. However, the effectiveness of nutrition consultation on the prevention of chronic diseases, such as hyperlipidemia, hypertension and cardiovascular diseases, has few been studied. The effectiveness of dietary instructions provided to individuals by dietitians in primary health care institutes is yet to be validated with significant evidence. In addition, nutrition consultation methods, processes, and influencing factors on its results are seldom discussed. Therefore, this study aims to investigate the frequency of personalized nutrition counseling's effect on individual cardiovascular risk factors. The study collected1 10 to 150 cases data who aimed to prevent or improve chronic diseases and had completed eight times individualized nutrition consultations from Bon Vivant Health Lifestyle Management Center, and the pre- and post-consultation data, including a regular blood test, blood glucose, blood lipid, liver panel, and inflammatory factors, will be analyzed. Blood were drawn before and after the first and the last time consultation for biochemical tests; blood pressure and body composition was also measured for comparison. The enrolled cases will be classified into two groups according to the subjects' duration of consultation: those who completed the consultation and subsequent tests in >24 weeks were in the control group, whereas those who completed the consultation and subsequent tests in <24 weeks were in the test group. The effectiveness of nutrition consultation toward managing cardiovascular disease risk factors and its correlation with the subjects' frequency of following the consultations was analyzed using the pre- and post-consultation data. It was found that personalized nutrition consultation significantly improved the subjects' risk factors of cardiovascular diseases, and that the treatment group showed a greater improvement than the control group which who require over 24 weeks to complete all consultation sessions.

Study Design

Study Type:
Observational
Actual Enrollment :
129 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases
Actual Study Start Date :
Apr 21, 2021
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Control group/ non-regularity group

those who completed 8 consultations by average interval time more than 3 weeks were in the non-regularity group

Behavioral: nutrition counseling
nutrition counseling

test group/ regularity group

those who completed the consultations and interval time within in 3 weeks were in the higher regularity

Behavioral: nutrition counseling
nutrition counseling

Outcome Measures

Primary Outcome Measures

  1. body weight [baseline, pre-intervention]

    body weight in kilograms

  2. body weight [immediately after the intervention]

    body weight in kilograms

  3. height [baseline, pre-intervention]

    height in meters

  4. height [immediately after the intervention]

    height in meters

  5. body mass index [baseline, pre-intervention]

    body mass index in kg/m^2

  6. body mass index [immediately after the intervention]

    body mass index in kg/m^2

  7. body fat [baseline, pre-intervention]

    body fat in ratio

  8. body fat [immediately after the intervention]

    body fat in ratio

  9. The concentration of blood triglyceride [baseline, pre-intervention]

    blood triglyceride in mg/dL

  10. The concentration of blood total cholesterol [within one week after the intervention]

    blood total cholesterol in mg/dL

  11. The concentration of blood low density lipoprotein-cholesterol [baseline, pre-intervention]

    blood blood low density lipoprotein-cholesterol in mg/dL

  12. The concentration of blood low density lipoprotein-cholesterol [within one week after the intervention]

    blood blood low density lipoprotein-cholesterol in mg/dL

  13. The concentration of blood high density lipoprotein-cholesterol-cholesterol [baseline, pre-intervention]

    blood high density lipoprotein-cholesterol in mg/dL

  14. The concentration of blood high density lipoprotein-cholesterol-cholesterol [within one week after the intervention]

    blood high density lipoprotein-cholesterol in mg/dL

  15. The concentration of blood high sensitive C-reactive protein [baseline, pre-intervention]

    blood high sensitive sensitive C-reactive protein in mg/L

  16. The concentration of blood high sensitive C-reactive protein [within one week after the intervention]

    blood high sensitive sensitive C-reactive protein in mg/L

  17. The concentration of blood fasting glucose [baseline, pre-intervention]

    blood fasting glucose in mg/dL

  18. The concentration of blood fasting glucose [within one week after the intervention]

    blood fasting glucose in mg/dL

  19. blood HbA1C [baseline, pre-intervention]

    blood HbA1C in percentage

  20. blood HbA1C [within one week after the intervention]

    blood HbA1C in percentage

  21. The concentration of blood insulin [baseline, pre-intervention]

    blood insulin in mg/dL

  22. The concentration of blood insulin [within one week after the intervention]

    blood insulin in mg/dL

  23. The activity of blood aspartate aminotransferase [baseline, pre-intervention]

    blood aspartate aminotransferase in U/L

  24. The activity of blood aspartate aminotransferase [within one week after the intervention]

    blood aspartate aminotransferase in U/L

  25. The activity of blood alanine aminotransferase [baseline, pre-intervention]

    blood alanine aminotransferase in U/L

  26. The activity of blood alanine aminotransferase [within one week after the intervention]

    blood alanine aminotransferase in U/L

  27. The concentration of blood urinary nitrogen (BUN) [baseline, pre-intervention]

    BUN in mg/L

  28. The concentration of blood urinary nitrogen (BUN) [within one week after the intervention]

    BUN in mg/L

  29. The concentration of blood creatinine [baseline, pre-intervention]

    BUN in mg/dL

  30. The concentration of blood creatinine [within one week after the intervention]

    BUN in mg/dL

  31. The concentration of blood uric acid [baseline, pre-intervention]

    blood uric acid in mg/dL

  32. The concentration of blood uric acid [within one week after the intervention]

    blood uric acid in mg/dL

  33. The concentration of blood total protein [baseline, pre-intervention]

    blood uric acid in mg/dL

  34. The concentration of blood total protein [within one week after the intervention]

    blood uric acid in mg/dL

  35. The concentration of blood albumin [baseline, pre-intervention]

    blood uric acid in mg/dL

  36. The concentration of blood albumin [within one week after the intervention]

    blood uric acid in mg/dL

  37. The concentration of blood globulin [baseline, pre-intervention]

    blood uric acid in mg/dL

  38. The concentration of blood globulin [within one week after the intervention]

    blood uric acid in mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age ≧ 20

  • Anyone of follow: body mass index > 24 systolic blood pressure > 120 mmHg diastolic blood pressure > 80 mmHg triglyceride > 150 mg/dL fasting blood glucose >100 mg/dL

Exclusion Criteria:
  • Age <20

  • pregnant

  • Mental problem

  • unable to do the measurement of body composition

  • incomplete the nutritional counseling program

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Taipei Taiwan 110

Sponsors and Collaborators

  • Taipei Medical University

Investigators

  • Study Chair: Suh-Ching Yang, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05092087
Other Study ID Numbers:
  • N202103134
First Posted:
Oct 25, 2021
Last Update Posted:
Oct 25, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021