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临床试验/NCT05088863
NCT05088863招募中不适用

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

St. Boniface Hospital2 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2022年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
384
试验地点
2
主要终点
3-day food record to assess food choices to achieve health claim

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

3-day food record to assess food choices to achieve health claim

时间窗: Two weeks

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.

Were they able to achieve the target laid out in the health claim

时间窗: 2 weeks

Questionnaire to identify barriers to implementation of health claim

Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim

时间窗: Four weeks

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

次要结局

  • Barriers to implementation of dietary change(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Heather Blewett

Principal Investigator

St. Boniface Hospital

研究点 (2)

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