Effectiveness of Written Dietary Advice on Lipoproteins -... | NCT03528252

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

NCT03528252

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Apr 26, 2019Actual

Enrollment

113Actual

Phase

Not Applicable

Conditions

Cholesterol, LDL

Interventions

Written advice LDL Cholesterol
Written advice Triglycerides

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Dnr 2018/119	Other Identifier	Uppsala Regional Ethics Committee

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2018Actual

Primary Completion Date

Apr 18, 2019Actual

Completion Date

Apr 18, 2019Actual

First Submitted Date

Apr 19, 2018

First Submission Date that Met QC Criteria

May 16, 2018

First Posted Date

May 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2019

Last Update Posted Date

Apr 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Iggman, General practitioner, Principal Investigator, Associated researcher, Uppsala UniversityPrincipal Investigator

Lead Sponsor

Uppsala UniversityOTHER

Collaborators

Name	Class
Dalarna County Council, Sweden	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Written advice LDL Cholesterol	Other	One A4 paper with written information on both sides	LDL Cholesterol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL Cholesterol	Change in plasma LDL Cholesterol levels	3 weeks and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Total Cholesterol	Change in plasma Total Cholesterol levels	3 weeks and 6 months
HDL Cholesterol	Change in plasma HDL Cholesterol levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Iggman, M.D. Ph.D	Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Svärdsjö Primary Health Care Centre		Falun	Dalarna County	79023	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

N/A, data sharing is not included in Ethics application. Further consent from participants may be required.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Apr 18, 2019	Apr 18, 2019	SAP_000.pdf
Prot	Yes	No	No	Study Protocol	Apr 23, 2019	Apr 23, 2019	Prot_001.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

Masking Description

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.

Who Masked

ParticipantCare ProviderInvestigator