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临床试验/NCT01982981
NCT01982981已完成不适用

Instrument Design and Validation to Evaluate the Perception of Well-being Associated to Plain Water Consumption Among Mexican Adults Residing in the City of "Cuernavaca".

Mexican National Institute of Public Health2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
2
主要终点
Wellbeing Perception

研究概览

简要总结

Nowadays, it is common to ingest beverages other than plain water, which range from flavored with a low energy input to others of high input. In Mexico, flavored beverage ingestion is believed to be displacing plain water; this phenomenon is raising concern in the health sector, due to the relation between flavored beverage intake and the increase in obesity and, consequently, chronic diseases.

Up until now, there is no instrument available to characterize the perception of the Mexican population's well-being, beliefs and knowledge regarding plain water ingestion, nor is there an instrument capable of quantifying the daily water ingestion.

The purpose of this study is design and validate a questionnaire to identify and evaluate the perception of well-being (PWBQ) related to plain water consumption in a sample of adult men and women of the city of Cuernavaca.

详细描述

Water makes up the majority of the human body; it is vital to ingest it every day to maintain proper hydration and be able to carry out the different cellular processes that make life possible.Plain water is the ideal liquid to perform all the cellular functions without the risk of ingesting substances or elements that could bring energy or represent other risks to health.

Currently, water ingestion recommendations offered vary dramatically among individuals and populations; for instance, individuals residing in dry and hot climates, as well as athletes, may have a greater need for water. The Dietary Reference Intake (DRI) suggests that the usual daily average ingestion in adults is 3.7 liters for men and 2.7 liters for women.

In Mexico, data from national health and nutrition surveys showed that highly energetic beverage consumption, such as sodas (carbonated or not), sugar-added or sugar-free fruit juices, fresh fruit waters ("aguas frescas") with sugar added and whole or flavored milk, doubled among the Mexican population between 1999 and 2006.

As such, this study has the following specific objectives:

    • Characterize beliefs, knowledge, attitudes and perceptions of physical well-being resulting from plain water consumption in a sample of adult men and women of the city of Cuernavaca, using qualitative techniques.
    • Validate the instrument through a process of instrument testing and adjustment, feasibility tests (consistency, temporary stability, inter-rater reliability and sensitivity to detect a change), content validity with field experts, criterion validity correlating the instrument with health questionnaire SF-36 and finally through an intervention in order to correlate the PWBQ with urine biochemical markers (volume, osmolarity, color, density, pH, Ca, Na and K), plain water ingestion reports, physical activity levels, diet, SF-36 and LCF.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Men and women from 21 to 59 years old
  • BMI ≥ 18.5 - ≥30
  • Light drinkers (general liquids <= 1.599 l and/or plain water <= 1000 ml)
  • Socioeconomic level C, D or E
  • Urine osmolality >=550 milliosmol/kg
  • Urine volume <=1500 ml

排除标准

  • Adults presenting the following characteristics will be excluded from the study:
  • Gastrointestinal problems (diarrhea)
  • Kidney insufficiency (stones and damaged kidney) or heart failure limiting the ingestion of liquids by medical prescription
  • Infections of the urinary tract or clinical dehydration, who have to ingest more liquids than usual by medical prescription
  • Currently pregnant or breast-feeding.
  • Unusually excessive ingestion of alcoholic beverages -defined as > 21 drinks per week in men or >4 per occasion and >10 drinks per week in women or >3 per occasion.
  • Being or having recently (less than 6 months ago) followed a nutritional program.
  • Taking anorexigenic or other weight-loss drugs (Xenical)
  • Suffering from any kind of eating disorder (anorexia or bulimia)

结局指标

主要结局

Wellbeing Perception

时间窗: 8 weeks

次要结局

未报告次要终点

研究者

发起方
Mexican National Institute of Public Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Simon Barquera, MD, MS, PhD

Director of Research in Nutrition Policy and Programs

Mexican National Institute of Public Health

研究点 (2)

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