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

NCT03528252 | Completed

• 2 other identifiers: MYDICLINDnr 2018/119
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol, LDL

Keywords

cholesterol; LDL cholesterol; Triglycerides; Diet; Food; Lipoproteins

Outcome Measures

Primary Outcomes (1)

• LDL Cholesterol

  Change in plasma LDL Cholesterol levels

  3 weeks and 6 months

Secondary Outcomes (11)

• Total Cholesterol

  3 weeks and 6 months

• HDL Cholesterol

  3 weeks and 6 months

• Apolipoproteins

  3 weeks and 6 months

• Success rate

  3 weeks and 6 months

• Responder effect

  6 months and 3 weeks, respectively

Study Arms (2)

LDL Cholesterol

ACTIVE COMPARATOR

Will receive dietary advice effective for reducing LDL cholesterol.

Other: Written advice LDL Cholesterol

Triglycerides

SHAM COMPARATOR

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

Other: Written advice Triglycerides

Interventions

Written advice LDL Cholesterol OTHER

One A4 paper with written information on both sides

Also known as: Active Intervention

LDL Cholesterol

Written advice Triglycerides OTHER

One A4 paper with written information on both sides

Also known as: Control Group

Triglycerides

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Dalarna County Council, Sweden: collaborator

Study Sites (1)

Svärdsjö Primary Health Care Centre

Falun, Dalarna County, 79023, Sweden

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• David Iggman, M.D. Ph.D

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General practitioner, Principal Investigator, Associated researcher

Model Details: Two identical parallel groups

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 17, 2018
• Study Start: May 16, 2018
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)