跳至主要内容
临床试验/NCT02682160
NCT02682160已完成不适用

Pilot Study to Evaluate the Evolution of Daily Protein Intake in Obese Patients With Recent Bariatric Surgery, Using the Software Protein Assistant.

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
The primary outcome is the evolution of the average of protein's intake in grams/day (calculated on a 3 day's dietary record) between the first record and the last one (3 months after surgery)

研究概览

简要总结

The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

详细描述

After a bariatric surgery, food intake is reduced. Patients should favor proteins to avoid loss of muscles. The guidelines recommend a minimal protein's intake of 60g per day. But this goal is achieved only for 55 to 60 % patients 4 months after surgery and 50 à 65 % patients at one year.

Protein assistant is a software which can calculate the amount of proteins eaten per day and can propose solutions if the intake is insufficient.

The main objective of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

Protein Assistant is suggested 1 month after bariatric surgery on a digital tablet. The patient is educated to use Protein Assistant. The patient has to complete a dietary record every 2 weeks during 2 months. The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent a bariatric surgery a month +/- one week ago
  • Able to use a digital tablet
  • With internet access at home
  • Accepting modalities of formation and of digital tablet lending
  • When the average of protein intake is under 60g/j on a 3 days dietary record, one month after bariatric surgery

排除标准

  • Lack of understanding of the use of a digital tablet
  • Under the protection of justice
  • Person participating to another trial
  • Pregnant or breast-feeding women

结局指标

主要结局

The primary outcome is the evolution of the average of protein's intake in grams/day (calculated on a 3 day's dietary record) between the first record and the last one (3 months after surgery)

时间窗: 3 months after surgery

次要结局

  • the effect of Protein Assitant's use : evaluation of the % of patients reaching the goal of 60g per day of protein's intake 3 months after surgery and at each dietary record.(3 months after surgery)
  • patient's satisfaction(3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验