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临床试验/NCT06547983
NCT06547983已完成不适用

Effectiviteit en Beleving Van FooDIYou

TNO1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Body weight in kilograms

研究概览

简要总结

Studies have shown that personalized nutrition advice is more effective compared to generic nutrition advice for weight loss purposes. However, since decentralization of clinical trials is on the rise, it of interest to test whether personalized nutrition advice is as effective when provided fully digitally. In the current study the investigators compare the effects of generic vs. personal nutritional interventions in a fully digital study. Three groups are included, a control group receiving generic nutritional advice, an intervention group receiving personalized nutrition advice and an intervention plus group receiving personalized nutrition advice plus personalized meals. The trial takes six weeks. Anthropometric data are collected every two weeks and data on changes in nutritional diet are collected at the beginning and end of the intervention. In addition, the opinion of the participants on trial participation is asked as well every two weeks during the trial.

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
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 25-60 years
  • •BMI between 25 and 40
  • •Motivated to lose weight
  • •Can fill in a digital questionnaire
  • •Posses a smartphone, computer, weighing scale and measuring tape to perform anthropometric measurements.

排除标准

  • •Any food allergy
  • •Chronic diseases influencing food intake (e.g., IBD)
  • •Participating in another intervention study
  • •Females in menopausal transition
  • •Follow a specific diet

研究组 & 干预措施

Control group

No Intervention

Intervention group

Experimental

干预措施: Personalized nutritional advice (Other)

Intervention plus group

Experimental

干预措施: Personalized nutritional advice and food boxes (Other)

结局指标

主要结局

Body weight in kilograms

时间窗: 6 weeks

次要结局

  • Body height in meters(6 weeks)
  • Hip circumference in centimeters(6 weeks)
  • Waist circumference in centimeters(6 weeks)
  • Neck circumference in centimeters(6 weeks)
  • Wrist circumference in centimeters(6 weeks)
  • BMI as calculated by combining body weight and height (kg/m^2)(6 weeks)
  • Dietary habits as measured using the Nutri+ Module(6 weeks)
  • Opinion on digital intervention as measured using an online questionnaire.(6 weeks)

研究者

发起方
TNO
申办方类型
Other
责任方
Sponsor

研究点 (1)

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