Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial (MYDICLIN)

Uppsala University

Status: Completed

Conditions: Cholesterol, LDL

Treatments: Other: Written advice Triglycerides; Other: Written advice LDL Cholesterol

Study type: Interventional

Funder types: Other

Identifiers

NCT03528252

Dnr 2018/119 (Other Identifier)

MYDICLIN

Details and patient eligibility

About

This study investigates the effect of detailed, written dietary advice for improving blood lipids, in a primary care setting. n=222 participants will be randomized to Active Intervention or Control Group. After 3 weeks' intervention, participants will receive written feedback on the effect on their blood lipids. After 6 months, another blood sample is drawn and participants will receive further written feedback.

Full description

The Active Intervention Group will receive detailed dietary advice based on current evidence for food choices that improve LDL cholesterol levels. The information will contain motivational strategies, e.g. "It's great that you want to improve your blood lipids! What are your three main reasons that you want to improve your blood lipids? What food choices suit you? How low can you go?" Participants will receive a table of ten suggested healthy food choices and be instructed to mark for each day a certain food change has been made.

The Control Group will receive similar advice and motivational strategies, with the one difference being the dietary advice, that will focus on Triglycerides instead of LDL cholesterol.

Enrollment: 113 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Listed patient at Svärdsjö Primary Health Care Centre
• Willing to reduce blood lipids

Exclusion criteria

• Drugs affecting blood lipids (statins, ezetimibe, fibrates, PCSK9-inhibitors, neuroleptic drugs, cortisone, amiodarone, estrogen, progesterone, testosterone, cyclosporin, tacrolimus, loop diuretics, protease inhibitors and anti-convulsants; whereas beta blockers, thiazide diuretics, and SGLT2-inhibitors are allowed under established medication
• Current malignant disease
• Extreme diet
• Abnormal metabolism e.g. uncontrolled hypothyroidism
• Dementia
• Unability to comprehend written information in Swedish
• Other participant from same household
• Current employment on Svärdsjö Primary Health Care Centre

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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113 participants in 2 patient groups

LDL Cholesterol

Active Comparator group

Description:

Will receive dietary advice effective for reducing LDL cholesterol.

Treatment:

Other: Written advice LDL Cholesterol

Triglycerides

Sham Comparator group

Description:

Will not be aware that they are in fact Control Group. Will receive dietary advice effective for reducing Triglycerides, but neutral for LDL cholesterol.

Treatment:

Other: Written advice Triglycerides