Instrument Design and Validation to Asses the Perception of Wellbeing Associated to Plain Water.

NCT01982981 | Completed DMC

• 1 other identifier: CINYS 917
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wellbeing

Keywords

perception; wellbeing; plain water

Outcome Measures

Primary Outcomes (1)

• Wellbeing Perception

  8 weeks

Study Arms (2)

control

NO INTERVENTION

The control group only be assessed

water provision

EXPERIMENTAL

The experimental group get water every 15 days

Other: water provision

Interventions

Water provision OTHER

perception behavioral change at the beginning and at the end of the intervention

Also known as: Treatment 1 (Control) Vs Treatment 2 (water provision)

water provision

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Literacy
• Urine osmolality \>=550 milliosmol/kg
• Urine volume \<=1500 ml

You may not qualify if:

• 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
• Diabetes
• 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)

Sponsors & Collaborators

• Mexican National Institute of Public Health: lead

Study Sites (1)

Mexican National Institute of Public Health

Cuernavaca, Morelos, 62100, Mexico

Location

Study Officials

• Simón Barquera, PhD

  Mexican National Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research in Nutrition Policy and Programs

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: November 13, 2013
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

ME (1)