Clinical trial NCT05088863: Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging
Official title: Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Claim Implementation
Keywords: health claim
flax
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2021-10-22
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: 3-day food record to assess food choices to achieve health claim
timeFrame: Two weeks
measure: Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim
timeFrame: Four weeks
measure: Were they able to achieve the target laid out in the health claim
timeFrame: 2 weeks
Secondary outcomes:
measure: Barriers to implementation of dietary change
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: I. H. Asper Clinical Research Institute
state: Manitoba
Study officials:
affiliation: Agriculture and Agri-Food Canada
name: Heather Blewett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.