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

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

Study Overview

• Status: Recruiting
• Conditions: Health Claim Implementation
• Intervention / Treatment: Other: flaxseed

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Blewett, PhD; Phone Number: 204 237-2954; Email: heather.blewett@agr.gc.ca
• Study Contact Backup: Name: Jo-Ann Stebbing, MSC; Phone Number: 204 258-1209; Email: jstebbing@sbrc.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Recruiting
      • I. H. Asper Clinical Research Institute
      • Contact: Heather J Blewett, PhD; Phone Number: 204-237-2954; Email: hblewett@sbrc.ca
      • Contact: Heather J Blewett, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Implementation of health claim; Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet	Other: flaxseed; 40g of flaxseed per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-day food record to assess food choices to achieve health claim	A list of flax containing foods from the 3-day food record will be created and the frequency with which each food item was selected will be recorded.	Two weeks
Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim	3 day food records before and after change in diet to address health claim will be entered into nutrition analysis software to calculate nutrient intake	Four weeks
Were they able to achieve the target laid out in the health claim	Questionnaire to identify barriers to implementation of health claim	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to implementation of dietary change	Questionnaire to identify if price, availability, sensory aspects of food, ease of preparation are barriers to implementation of the health claim	2 weeks

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Collaborators: Agriculture and Agri-Food Canada
• Investigators: Principal Investigator: Heather Blewett, PhD, Agriculture and Agri-Food Canada

Publications and helpful links

General Publications

• 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.

Helpful Links

• City of Winnipeg. Population of Winnipeg. April 2021:
• 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:
• 5. Statistics Canada. Question #17 on the 2016 Census of Population 2A-L questionnaire:
• 2. Summary of Health Canada's Assessment of a Health Claim about Ground Whole Flaxseed and Blood Cholesterol Lowering

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: health claim; flax
• Other Study ID Numbers: HS25165 (B2021:102) (Other Identifier: Biomedical research Ethics Board, University of Manitoba)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: From the time the data is collected until the manuscript is accepted for publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No