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

Dyslipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695837
• Other study ID #: 5P20RR016464-11/8
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: September 27, 2012
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
United States	UNSOM Internal Medicine	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-Cholesterol		up to 6 months	No
Secondary	Total Cholesterol		at 3 and 6 months	No
Secondary	Triglycerides		at 3 and 6 months	No
Secondary	HDL-Cholesterol		at 3 and 6 months	No
Secondary	diet score		at 3 and 6 months	No