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

NCT01695837 | Completed

• 2 other identifiers: 5P20RR016464-11/85P20RR016464
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Dyslipidemia

Keywords

Diet counseling; primary care

Outcome Measures

Primary Outcomes (1)

• LDL-Cholesterol

  up to 6 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Group A-dietary counseling month 0-6

EXPERIMENTAL

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

OTHER

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

Interventions

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

Group A-dietary counseling month 0-6; Group B- Dietary counseling month 3-6

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

UNSOM Internal Medicine

Reno, Nevada, 89511, United States

Location

Related Publications (1)

• 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.

  PMID: 23663789 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Doina Kulick, MD, MS

  University of Nevada School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: September 28, 2012
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

US (1)