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

Study Overview
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Brief Summary
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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
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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
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Dyslipidemia

Intervention / Treatment
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* Behavioral: Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A-dietary counseling month 0-6<br>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<br> <br> |
| Other: Group B- Dietary counseling month 3-6<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-Cholesterol |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet counseling, primary care