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

NCT ID: NCT01695837

Last Updated: 2012-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-06-30

Brief 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

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 .

Conditions

Dyslipidemia

Keywords

Diet counseling; primary care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

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

Intervention Type: BEHAVIORAL

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Doina Kulick, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doina Kulick, MD, MS

Role: STUDY_DIRECTOR

University of Nevada School of Medicine

Locations

UNSOM Internal Medicine

Reno, Nevada, United States

Countries

United States

References

Kulick D, Langer RD, Ashley JM, Gans KM, Schlauch K, Feller C. Live well: a practical and effective low-intensity dietary counseling intervention for use in primary care patients with dyslipidemia--a randomized controlled pilot trial. BMC Fam Pract. 2013 May 12;14:59. doi: 10.1186/1471-2296-14-59.

Reference Type: DERIVED

PMID: 23663789 (View on PubMed)

Other Identifiers

5P20RR016464

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5P20RR016464-11/8

Identifier Type: -

Identifier Source: org_study_id