跳至主要内容
临床试验/NCT03337412
NCT03337412已完成不适用

Therapeutic Care and Education in Endocrinology-Diabetes-Nutrition: Evaluation of the Interest of the APA Educator (Adapted Physical Activity Educator) for the Establishment of Physical Activities in the Management and Prevention of Overweight and Obesity

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Chronological evolution of the physical activity score of patients benefiting from the education program with intervention of the adapted physical activity educator

研究概览

简要总结

An uncontrolled, non-randomized, open-plan, multi-centre study of treatment and therapeutic education in endocrinology-diabetes-Nutrition that seeks to assess the interest of an adapted physical activity educator for the implementation In place of physical activities in the management and prevention of overweight and obesity. The proposed study seeks to promote the physical activity (PA) to patients and employees, including the encouragement of physical activity in a guided and personalized way, through workshops on working time, and follow-up of the evolution of the PA through a Adapted questionnaire.

详细描述

The evaluation will be proposed

  • in the Department of Endocrinology, Metabolic diseases and Nutrition of the Nantes University Hospital to all patients participating in "overweight education groups" in complete hospitalization or in day hospital
  • to the employees of the group Fleury-Michon volunteers.
  • During a recruitment period of 6 months required for the recruitment of 100 patients and 80 employees;
  • For a total duration of the research for each 1 year participant. Patients and employees will be systematically informed of the project and their consent will be collected by oral and plotted in the medical file and in the employee file, kept by the adapted physical activity educator.

For the hospital phase, patients will be asked to complete questionnaires regarding their physical activity, diet and quality of life prior to hospital care. For an evaluation of the chronological evolution of their physical activity, they will be invited to complete the global Physical Activity Questionnaire (GPAQ 2.0), every 2 months, from their home, via the Internet from a secure link (ECRF clinsight) for the duration of the Research is one year. At 6 months during a telephone contact and at 12 months, during a consultation, the food and quality of life questionnaires will also have to be informed. The evolution of weight, body mass index (BMI) and metabolic biological factors (fasting blood glucose and lipid balance) will also be collected.

For the enterprise phase, employees will benefit from a life-health awareness program, accompanied by an APA educator, they are offered the opportunity to participate in physical activity workshops on a regular basis (12 workshops minimum over 6 months), adapted to their abilities and personalized. They will be invited to fill, from their home or on the website Fleury Michon, via the Internet from a secure link (ECRF clinsight) the same type of questionnaire

研究设计

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

  • Adult Patients hospitalized for weight problem in the service of endocrinology, metabolic diseases and Nutrition of the Nantes University Hospital's and employees of the company Fleury-Michon not contraindicated to the practice of a sports activity by the dealing doctor
  • benefiting from the intervention of an APA educator
  • able to complete the questionnaires of physical activity, eating habits, quality of life and satisfaction
  • having given their oral consent

排除标准

  • Major subjects protected, under guardianship or curators;
  • Pregnant women on a declarative test

结局指标

主要结局

Chronological evolution of the physical activity score of patients benefiting from the education program with intervention of the adapted physical activity educator

时间窗: every 2 months over 12 months

Physical activity will be evaluated both qualitatively (low, moderate and intense) and quantitatively (expressed as metabolic Equivalent of Task: MET-min/week) through the World Health Organization GPAQ 2.0 questionnaire, based on physical activities at work, In moving and hobbies.

次要结局

  • Evolution of the quality of life(at 6 months and 1 year)
  • Evolution of patients satisfaction(at 6 months and 1 year)
  • Evolution of BMI(at 6 months and 1 year)
  • Evolution of the basic energy expenditure(at 12 months)
  • Evolution of metabolic parameters (fasting blood glucose and lipid balance)(at 12 months)
  • Changes in eating habits(at 6 months and 1 year)
  • musculoskeletal disorders(at 6 months and 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

招募中
不适用
Multicentre study about therapie management, nutrient supply and long-term outcome of patients with mild hyperphenylalaninemia and classical phenylketonuriaE70.0E70.1Classical phenylketonuriaOther hyperphenylalaninaemias
DRKS00004942niversität Leipzig50
进行中(未招募)
不适用
AN OPEN, RANDOMISED, MULTICENTRE, CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS AND MINIMAL STEROIDS IN COMBINATION WITH EITHER A MONOCLONAL ANTI-IL2R ANTIBODY (DACLIZUMAB) OR MYCOPHENOLATE MOFETIL IN LIVER ALLOGRAFT TRANSPLANTATION - Marsilea (Mycophenolate mofetil or Antibodies with Reduced Steroids in Liver transplantation)Patients with hepatic disease who will undergo primary orthotopic liver or split liver allograft transplantation.MedDRA version: 7.0Level: LLTClassification code 10019650
EUCTR2004-001617-34-GBAstellas Pharma Europe Ltd600
进行中(未招募)
不适用
AN OPEN, RANDOMISED, MULTICENTRE, CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS AND MINIMAL STEROIDS IN COMBINATION WITH EITHER A MONOCLONAL ANTI-IL2R ANTIBODY (DACLIZUMAB) OR MYCOPHENOLATE MOFETIL IN LIVER ALLOGRAFT TRANSPLANTATION - Marsilea (Mycophenolate mofetil or Antibodies with Reduced Steroids in Liver transplantation)Patients with hepatic disease who will undergo primary orthotopic liver or split liver allograft transplantation.MedDRA version: 7.0Level: LLTClassification code 10019650
EUCTR2004-001617-34-SEAstellas Pharma Europe Ltd600
进行中(未招募)
不适用
AN OPEN, RANDOMISED, MULTICENTRE, CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS AND MINIMAL STEROIDS IN COMBINATION WITH EITHER A MONOCLONAL ANTI-IL2R ANTIBODY (DACLIZUMAB) OR MYCOPHENOLATE MOFETIL IN LIVER ALLOGRAFT TRANSPLANTATION - Marsilea (Mycophenolate mofetil or Antibodies with Reduced Steroids in Liver transplantation)Patients with hepatic disease who will undergo primary orthotopic liver or split liver allograft transplantation.MedDRA version: 7.0Level: LLTClassification code 10019650
EUCTR2004-001617-34-HUAstellas Pharma GmbH600
进行中(未招募)
不适用
AN OPEN, RANDOMISED, MULTICENTRE, CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS AND MINIMAL STEROIDS IN COMBINATION WITH EITHER A MONOCLONAL ANTI-IL2R ANTIBODY (DACLIZUMAB) OR MYCOPHENOLATE MOFETIL IN LIVER ALLOGRAFT TRANSPLANTATION - Marsilea (Mycophenolate mofetil or Antibodies with Reduced Steroids in Liver transplantation)Patients with hepatic disease who will undergo primary orthotopic liver or split liver allograft transplantation.MedDRA version: 7.0Level: LLTClassification code 10019650
EUCTR2004-001617-34-DKAstellas Pharma GmbH600
Adapted Physical Activity Study | 临床试验