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临床试验/NCT01602965
NCT01602965已完成不适用

Personalized Nutritional Program Plus a Nutritional Counseling Monthly Phone Call Versus a Personalized Nutritional Program With Self Help Informative Booklet

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年9月1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
入组人数
40
试验地点
1
主要终点
Weight Loss

研究概览

简要总结

The purpose of this study is to evaluate the most effectiveness between a personalized nutritional program with a counseling monthly phone call Versus personalized nutritional program with self help Informative Booklet in a group of obesity or overweight patients without counseling phone call.

详细描述

Evaluate the best effectiveness between two methods applied in the Dietary Service of institute orthopedic Rizzoli for the achievement of the weight loss. Personalized nutritional program with counseling phone call versus personalized nutritional program with self help Informative Booklet in a controlled group.There will be compared two groups of patients: First group: patients subject to balanced personalized nutritional program associated to counseling monthly phone call ; compliance and loss of weight will be done monthly for one year. Second group: patients subject to balanced personalized nutritional program associated to self help informative Booklet; compliance and loss of weight will be done after six months and after one year from the first meeting.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Female and male
  • •BMI >25 and <35
  • •Ages Eligible for Study: 18 years old to 75 years old
  • •Patients of the Institute Orthopedic Rizzoli subject to personalized nutritional program admitted to the wards and patients attending the clinic of Anaesthesiology, analgesic therapy, Rheumatology
  • •participants gave informed consent

排除标准

  • •Patients with psychiatric disorders (depression, bulimia, anorexia
  • •Concomitant use of medicines or food supplements that can alter the weight loss.
  • •Patients with inclusion criteria that have not signed the informative report and the declaration of consent.

研究组 & 干预措施

counseling monthly phone calls

Experimental

the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.

干预措施: Counseling Monthly Phone Calls (Procedure)

self help informative Booklet

Active Comparator

Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.

干预措施: Self Help Informative Booklet (Procedure)

结局指标

主要结局

Weight Loss

时间窗: Percent Change in weight loss at one year

The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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