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Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging

NCT ID: NCT05088863

Last Updated: 2024-11-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2025-11-30

Brief Summary

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A survey designed to examine how consumers adapt their diet in response to health claim messaging.

Detailed Description

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384 participants will be recruited to participate (n=32/group) ensuring equal numbers based on gender (men and women), income (low and medium-high), and age (18-35, 36-55, \>56 years). Participants will be asked to prepare a 3-day food record representative of their current dietary intake. Participants will then be told, "Health Canada has approved the following health claim: 40g of ground flaxseed per day has been shown to help lower cholesterol, which is a risk factor for heart disease." Without any further guidance, participants will then be asked to modify their diet to achieve 40g per day of flaxseeds for the following 2 weeks. They will be asked to prepare another 3-day food record so we can see if/how their diet changed. At the end of the 2-week period, participants will be asked if they were successful with the changes and what barriers they faced in implementing these changes. This survey will be accomplished remotely with informed consent and communication with participants happening over the phone or videoconference. Participants will mail the food records to clinical trial staff. Analysis of food records will identify the food choices used to achieve dietary change, if these changes altered nutrient intake compared to their usual diet and if they were able to achieve the target laid out (ie. 40g flaxseed per day). A questionnaire will be used to identify barriers to implementation of dietary change (ie. price, availability, sensory aspects of food, ease of preparation).

Conditions

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Health Claim Implementation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Implementation of health claim

Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet

Group Type OTHER

flaxseed

Intervention Type OTHER

40g of flaxseed per day

Interventions

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flaxseed

40g of flaxseed per day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Man or woman, age ≥18 years;
2. Willing to provide informed consent;
3. Willing/able to comply with the requirements of the study;
4. Have a mailing address in the Winnipeg census metropolitan area (City of Winnipeg and the municipalities of West St. Paul, East St. Paul, Headingley, Macdonald, Richot, Tache, Springfield, Rosser, St. Francois Xavier and St. Clements)4.

Exclusion Criteria

1. Allergy, aversion or unwillingness to eat whole ground flaxseed;
2. Consuming ≥40g whole ground flaxseed/day;
3. A family member within the same household is participating or has participated in this study;
4. Currently participating in a food trial or dietary program that does not allow change in food choice.
5. Pregnant or lactating
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Heather Blewett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather Blewett, PhD

Role: PRINCIPAL_INVESTIGATOR

Agriculture and Agri-Food Canada

Locations

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I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heather Blewett, PhD

Role: CONTACT

[email protected]
204 237-2954

Jo-Ann Stebbing, MSC

Role: CONTACT

[email protected]
204 258-1209

Facility Contacts

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Heather J Blewett, PhD

Role: primary

[email protected]
204-237-2954

Heather J Blewett, PhD

Role: backup

References

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Kaur A, Scarborough P, Rayner M. A systematic review, and meta-analyses, of the impact of health-related claims on dietary choices. Int J Behav Nutr Phys Act. 2017 Jul 11;14(1):93. doi: 10.1186/s12966-017-0548-1.

Reference Type BACKGROUND
PMID: 28697787 (View on PubMed)

Related Links

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https://www.winnipeg.ca/cao/pdfs/population.pdf

City of Winnipeg. Population of Winnipeg. April 2021:

http://doi.org/10.25318/1110024101-eng

Statistics Canada. Table 11-10-0241-01 Low income cut-offs (LICOs) before and after tax by community size and family size, in current dollars DOI:

https://www23.statcan.gc.ca/imdb/p3Instr.pl?Function=getInstrumentList&Item_Id=295122&UL=1V&

5\. Statistics Canada. Question #17 on the 2016 Census of Population 2A-L questionnaire:

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/pdf/label-etiquet/claims-reclam/assess-evalu/flaxseed-graines-de-lin-eng.pdf

2\. Summary of Health Canada's Assessment of a Health Claim about Ground Whole Flaxseed and Blood Cholesterol Lowering

Other Identifiers

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HS25165 (B2021:102)

Identifier Type: -

Identifier Source: org_study_id

HS25165 (B2021:102)

Identifier Type: OTHER

Identifier Source: secondary_id