Live Well: A Practical and Effective Low-Intensity Dietary Counseling Intervention for Use in Primary Care Patients With Dyslipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Doina Kulick, MD, University of Nevada
ClinicalTrials.gov Identifier:
NCT01695837
First received: September 27, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity dietary counseling intervention provided by the primary care physician (PCP), in patients at risk for cardiovascular diseases


Condition Intervention
Dyslipidemia
Behavioral: Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • LDL-Cholesterol [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Cholesterol [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
  • HDL-Cholesterol [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
  • diet score [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A-dietary counseling month 0-6

Group A Visit #1 - Weight, height, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the primary care physician (PCP) reviewed the results of the fasting lipid panel and diet test with the patient; the PCP provide the patient with written educational materials and access to the counseling website. Weekly automatic emails sent to patient reminding to visit the counseling website

Visit #2 - Same as visit #1. Weekly automatic emails sent to patient reminding to visit the counseling website.

Visit #3 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the PCP reviewed the results of the new fasting lipid panel and diet test with the patient.

Behavioral: Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6
Group B- Dietary counseling month 3-6

Group B Visit #1: Weight, height, blood pressure and pulse were measured at the beginning of the visit. Follow up visit and lab order were scheduled for 3 months. No blood test or diet test results were reviewed with the patient.

Visit #2 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the PCP reviewed the results of the two fasting lipid panels ; the PCP provide the patient with written educational materials and access to the counseling website. Weekly automatic emails sent to patient reminding to visit the counseling website

Visit #3 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the PCP reviewed the results of the new fasting lipid panel and diet test with the patient.

Behavioral: Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6

Detailed Description:

The objective of this study is to design and evaluate the feasibility and the effect on diet quality and blood lipids a new dietary counseling intervention that will be sustainable in the "real-world" settings of the current clinical practice. The intervention will be initiated by the primary care physician during the routine office visits and will use paper and web-based counseling materials. Internet based healthcare, or e-healthcare, is a consumer focused health care delivery paradigm that physicians and the healthcare system can no longer ignore. Lifestyle counseling and preventive medicine are potentially ideal areas of patient care that could be provided efficiently through this emerging venue of healthcare delivery. Internet access is near-universal for Americans under the age of 60: 90% of 18-29 year-olds, 85% of 30-49 year-olds, and 70% of 50-64 year-olds.

The aims of this study are: 1) - develop a patient self-administered, computerized version of the paper-based Rate-your-Plate dietary screening Questionnaire; 2) - create counseling materials on diet and cholesterol and build a secure, HIPAA compliant, interactive web-based counseling application that will allow patients to receive personalized counseling base on the results of the screening dietary questionnaire and the goals chosen by the patients; 3) - to test the feasibility of this intervention in the clinical settings of primary care, and evaluate its effect on lipids panel at 3 and 6 months .

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligibility required documentation of a LDL-cholesterol level of 130 mg/dL or higher within the 12 months prior to enrollment. Potential subjects were also required to have access to the Internet and an active email account. The use of lipid lowering drugs was not an exclusion, but patients taking these drugs had be on the same medication and dose for at least 3 months prior to enrollment, with no changes anticipated for the duration of the trial.

Exclusion Criteria:

  • We excluded patients with poorly controlled diabetes mellitus (defined by HbA1c>9%), serum creatinine above 1.5 mg/dL, malignancy, cirrhosis, eating disorders, acute coronary syndrome in the last three months, congestive heart failure NYHA class lll and lV, ongoing warfarin therapy, uncontrolled hypo- or hyperthyroidism, ongoing weight loss, history of bariatric surgery, pregnant women, and patients who scored more than 250 (on a scale of 100 to 300) on a food frequency questionnaire administered on the day of enrollment. Patients with a history of triglycerides >400 mg/dl were also excluded, since we used the Friedewald formula [LDL-C=Total cholesterol-(TGs/5+HDL-C)] to calculate LDL-cholesterol levels.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695837

Locations
United States, Nevada
UNSOM Internal Medicine
Reno, Nevada, United States, 89511
Sponsors and Collaborators
University of Nevada, Las Vegas
Investigators
Study Director: Doina Kulick, MD, MS University of Nevada School of Medicine
  More Information

No publications provided by University of Nevada, Las Vegas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doina Kulick, MD, Associate Professor of Medicine, University of Nevada
ClinicalTrials.gov Identifier: NCT01695837     History of Changes
Other Study ID Numbers: 5P20RR016464-11/8
Study First Received: September 27, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nevada, Las Vegas:
Diet counseling
primary care

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 20, 2014