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临床试验/ACTRN12622000852752
ACTRN12622000852752招募中未知

Medically Tailored Meals for diabetes and heart disease: an Australian trial of a 'Food is Medicine' intervention

The George Institute for Global Health0 个研究点目标入组 212 人开始时间: 2022年6月16日最近更新:

试验速览

阶段
未知
状态
招募中
入组人数
212

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • * Adults (greater than or equal to 18 years of age)
  • * Clinically diagnosed T2D for at least 12 months
  • * Persistently high blood glucose levels, defined as:
  • - For those referred by clinics: measured HbA1c greater than or equal to 7.5% at their most recent clinical assessment AND at least one more clinically measured HbA1c greater than or equal to 7.5% within the past 12 months.
  • - For those referred by Trial Facts or meal delivery companies: self-reported difficulty maintaining ideal blood sugar control AND measured HbA1c greater than or equal to 7.5% at their most recent clinical assessment within the past six months.
  • * Have difficulty getting and eating nutritious foods, assessed based judgement of the healthcare provider or a short questionnaire.

排除标准

  • * Unable or unwilling to provide informed consent.
  • * Not planning to stay within their home in Greater Sydney area in the next 7 months.
  • * Individuals who have had an episode of severe hypoglycaemia defined as having received glucagon, or required ambulance or emergency department visit for hypoglycaemia, or requiring assistance from another individual / third party for hypoglycaemia within the last 6 months.
  • * In hospice or palliative care
  • * Living in a facility that provides most or all their meals.
  • * Does not have freezers at home for storing study meals.
  • * Does not have a microwave for heating meals at home
  • * Existing medical conditions that severely limits dietary intake, requires individualised diets
  • * Those with active cancer, severe chronic kidney disease (stage 4 or worse), or heart failure
  • * Those with severe food allergies (but those with gluten or dairy intolerances can participate)
  • * Pregnant women
  • * People participating in any other lifestyle modification research trials
  • * For individuals referred from meal delivery companies: have not placed an order with the meal companies in the past 12 months.

研究者

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