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Идёт набор NCT05088863

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

Без фазы С лечением Health Claim Implementation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: flaxseed.
Кому может быть актуально
Состояния в реестре: Health Claim Implementation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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

Подробное описание

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).

Вмешательства

  • Другое flaxseed
    40g of flaxseed per day

Первичные конечные точки

  • 3-day food record to assess food choices to achieve health claim [Срок оценки: Two weeks]
  • Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim [Срок оценки: Four weeks]
  • Were they able to achieve the target laid out in the health claim [Срок оценки: 2 weeks]
Вторичные конечные точки (1)
  • Barriers to implementation of dietary change [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Канада · 1 центр
  • I. H. Asper Clinical Research Institute — Winnipeg

Публикации

  • 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

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗