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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-16

Study Completion Date

2019-04-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholesterol, LDL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two identical parallel groups

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Randomization by sealed envelopes, opened in private. Allocation sequence and envelopes provided by external agent. Participants are instructed not to discuss intervention outside household. No more than one (randomly selected) participant per household allowed.

Study Groups

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LDL Cholesterol

Will receive dietary advice effective for reducing LDL cholesterol.

Group Type ACTIVE_COMPARATOR

Written advice LDL Cholesterol

Intervention Type OTHER

One A4 paper with written information on both sides

Triglycerides

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

Group Type SHAM_COMPARATOR

Written advice Triglycerides

Intervention Type OTHER

One A4 paper with written information on both sides

Interventions

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Written advice LDL Cholesterol

One A4 paper with written information on both sides

Intervention Type OTHER

Written advice Triglycerides

One A4 paper with written information on both sides

Intervention Type OTHER

Other Intervention Names

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Active Intervention Control Group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes