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

Overview

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).

Interventions

• Other flaxseed
  40g of flaxseed per day

Primary outcome measures

• 3-day food record to assess food choices to achieve health claim [Time frame: Two weeks]
• Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim [Time frame: Four weeks]
• Were they able to achieve the target laid out in the health claim [Time frame: 2 weeks]

Secondary outcome measures (1)

• Barriers to implementation of dietary change [Time frame: 2 weeks]

Eligibility criteria

Inclusion criteria

• Man or woman, age ≥18 years;
• Willing to provide informed consent;
• Willing/able to comply with the requirements of the study;
• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Canada · 1 center

• I. H. Asper Clinical Research Institute — Winnipeg

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. PMID 28697787

Identifiers

NCT: NCT05088863 · HS25165 (B2021:102) · HS25165 (B2021:102)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗