Clinical trial NCT03528252: Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial
Official title: Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial (MYDICLIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesterol, LDL
Keywords: cholesterol
LDL cholesterol
Triglycerides
Diet
Food
Lipoproteins
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Dalarna County Council, Sweden
First posted: 2018-05-17
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two identical parallel groups
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL Cholesterol
timeFrame: 3 weeks and 6 months
Secondary outcomes:
measure: Total Cholesterol
timeFrame: 3 weeks and 6 months
measure: HDL Cholesterol
timeFrame: 3 weeks and 6 months
measure: Apolipoproteins
timeFrame: 3 weeks and 6 months
measure: Success rate
timeFrame: 3 weeks and 6 months
measure: Responder effect
timeFrame: 6 months and 3 weeks, respectively
measure: Double sampling requirement
timeFrame: 3 weeks and 6 months
measure: Cost of intervention
timeFrame: 3 weeks and 6 months
measure: Effective food choices
timeFrame: 3 weeks and 6 months
measure: Stated reasons
timeFrame: 3 weeks and 6 months
measure: PSCK9
timeFrame: 3 weeks and 6 months
measure: Lipoprotein(a)
timeFrame: 3 weeks and 6 months
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Svärdsjö Primary Health Care Centre
state: Dalarna
Study officials:
affiliation: Uppsala University
name: David Iggman, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: