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

Study Overview
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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).

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

Conditions
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Health Claim Implementation

Intervention / Treatment
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* Other: flaxseed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Implementation of health claim<br>Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet | Other: flaxseed<br>* 40g of flaxseed per day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health claim, flax