Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

NCT05092087 | Completed

• 1 other identifier: N202103134
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disease

Outcome Measures

Primary Outcomes (38)

• body weight

  body weight in kilograms

  baseline, pre-intervention

• body weight

  body weight in kilograms

  immediately after the intervention

• height

  height in meters

  baseline, pre-intervention

• height

  height in meters

  immediately after the intervention

• body mass index

  body mass index in kg/m\^2

  baseline, pre-intervention

• body mass index

  body mass index in kg/m\^2

  immediately after the intervention

• body fat

  body fat in ratio

  baseline, pre-intervention

• body fat

  body fat in ratio

  immediately after the intervention

• The concentration of blood triglyceride

  blood triglyceride in mg/dL

  baseline, pre-intervention

• The concentration of blood total cholesterol

  blood total cholesterol in mg/dL

  within one week after the intervention

• The concentration of blood low density lipoprotein-cholesterol

  blood blood low density lipoprotein-cholesterol in mg/dL

  baseline, pre-intervention

• The concentration of blood low density lipoprotein-cholesterol

  blood blood low density lipoprotein-cholesterol in mg/dL

  within one week after the intervention

• The concentration of blood high density lipoprotein-cholesterol-cholesterol

  blood high density lipoprotein-cholesterol in mg/dL

  baseline, pre-intervention

• The concentration of blood high density lipoprotein-cholesterol-cholesterol

  blood high density lipoprotein-cholesterol in mg/dL

  within one week after the intervention

• The concentration of blood high sensitive C-reactive protein

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

  baseline, pre-intervention

• The concentration of blood high sensitive C-reactive protein

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

  within one week after the intervention

• The concentration of blood fasting glucose

  blood fasting glucose in mg/dL

  baseline, pre-intervention

• The concentration of blood fasting glucose

  blood fasting glucose in mg/dL

  within one week after the intervention

• blood HbA1C

  blood HbA1C in percentage

  baseline, pre-intervention

• blood HbA1C

  blood HbA1C in percentage

  within one week after the intervention

• The concentration of blood insulin

  blood insulin in mg/dL

  baseline, pre-intervention

• The concentration of blood insulin

  blood insulin in mg/dL

  within one week after the intervention

• The activity of blood aspartate aminotransferase

  blood aspartate aminotransferase in U/L

  baseline, pre-intervention

• The activity of blood aspartate aminotransferase

  blood aspartate aminotransferase in U/L

  within one week after the intervention

• The activity of blood alanine aminotransferase

  blood alanine aminotransferase in U/L

  baseline, pre-intervention

• The activity of blood alanine aminotransferase

  blood alanine aminotransferase in U/L

  within one week after the intervention

• The concentration of blood urinary nitrogen (BUN)

  BUN in mg/L

  baseline, pre-intervention

• The concentration of blood urinary nitrogen (BUN)

  BUN in mg/L

  within one week after the intervention

• The concentration of blood creatinine

  BUN in mg/dL

  baseline, pre-intervention

• The concentration of blood creatinine

  BUN in mg/dL

  within one week after the intervention

• The concentration of blood uric acid

  blood uric acid in mg/dL

  baseline, pre-intervention

• The concentration of blood uric acid

  blood uric acid in mg/dL

  within one week after the intervention

• The concentration of blood total protein

  blood uric acid in mg/dL

  baseline, pre-intervention

• The concentration of blood total protein

  blood uric acid in mg/dL

  within one week after the intervention

• The concentration of blood albumin

  blood uric acid in mg/dL

  baseline, pre-intervention

• The concentration of blood albumin

  blood uric acid in mg/dL

  within one week after the intervention

• The concentration of blood globulin

  blood uric acid in mg/dL

  baseline, pre-intervention

• The concentration of blood globulin

  blood uric acid in mg/dL

  within one week after the intervention

Study Arms (2)

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

test group/ regularity group

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

Behavioral: nutrition counseling

Interventions

nutrition counseling BEHAVIORAL

nutrition counseling

Control group/ non-regularity group; test group/ regularity group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who volunteer to pay and completed nutrition consultations from Bon-Vivant Health Lifestyle Management Center.

You may qualify if:

• 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

You may not qualify if:

• Age \<20
• pregnant
• Mental problem
• unable to do the measurement of body composition
• incomplete the nutritional counseling program

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Suh-Ching Yang

  Taipei Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: October 25, 2021
• Study Start: April 21, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-04

Locations

TW (1)