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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: 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 .

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89511
      • UNSOM Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LDL-Cholesterol	up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Cholesterol	at 3 and 6 months
Triglycerides	at 3 and 6 months
HDL-Cholesterol	at 3 and 6 months
diet score	at 3 and 6 months

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Investigators: Study Director: Doina Kulick, MD, MS, University of Nevada School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): September 28, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: primary care; Diet counseling
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 5P20RR016464-11/8; 5P20RR016464 (U.S. NIH Grant/Contract)