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临床试验/NCT04245384
NCT04245384尚未招募不适用

Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services

Umeå University0 个研究点目标入组 400 人开始时间: 2023年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
Change in dietary intake

研究概览

简要总结

The project aims to investigate the effect of internet-based dietetic treatment (IDT) on patients, dietitians, and society.

The project will show:

  • If IDT is equivalent to traditional dietetic treatment with physical meetings
  • Patients' attitudes to, and experiences of, meeting a dietician through video calls
  • How the dietician's work environment and working methods are affected by IDT
  • If there are subgroups of patients where IDT is more or less appropriate
  • Health economic and environmental consequences of IDT The major shortage of dietitians leaves patients with non-communicable diseases (NCD) without qualified dietary treatment. In a pilot study, the investigators have shown that IDT has great potential to streamline healthcare and increase accessibility. In the project Dietitian online, the investigators will conduct an RCT with 400 NCD-patients allocated to either IDT or standard dietetic treatment to see if IDT affect treatment outcome and whether IDT is appropriate for everyone. Even though internet-based treatment (IT) increases rapidly in society, there is little knowledge about the patients' experiences and how healthcare personnel incorporates IT in their daily work. The investigators will conduct qualitative studies to meet this knowledge gap. General assumptions are that IT is beneficial for society, both economically and environmentally, but very few studies have been done. The project will incorporate a full health-economic evaluation, including environmental impact.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • seeking/being referred to a dietitian for the treatment of obesity (BMI≥25) or obesity in combination with:
  • type 2 diabetes (HbA1c>48mmol/mol) and/or
  • elevated blood lipids (total cholesterol >4,5 mmol/l and/or LDL >2,5 mmol/l and/or triglycerides >2,0 mmol/l) and/or
  • high blood pressure (>140/90 hg)

排除标准

  • other diagnoses requiring/might require nutritional treatment (eg cancer, COPD)
  • severe impairment of sight, hearing, or other disability where internet-based dietetic treatment is deemed difficult
  • pregnancy
  • need for interpreter

结局指标

主要结局

Change in dietary intake

时间窗: Change from baseline to three, six and twelve months after first treatment session

Dietary intake will be assessed using the Swedish National Food Administrations Food Index (minimum value 0, maximum value 12, higher score indicates a healthier diet). Intake of fruit and vegetables in grams, as well as intake of discretionary calories (sweets, snacks, fast food, sugary drinks, pastries), will also be assessed.

次要结局

  • Change in participant motivation(Change from baseline to three. six and twelve months after first treatment session)
  • Change in participant alliance to dietitian(Change from baseline to three and six months after first treatment session)
  • Change in participant activation(Change from baseline to six months after first treatment session)

研究者

申办方类型
Other
责任方
Sponsor

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