Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults

August 1, 2011 updated by: University of North Carolina, Chapel Hill

Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults

The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7294
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 years of age.
  • Body mass index (BMI) between 25.0-49.9 kg/m2.
  • Subject consumes at least 280 calories per day from caloric beverages.

Exclusion Criteria:

  • Report losing >5% of current body weight in the previous 6 months.
  • Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
  • Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
  • Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
  • Report hospitalization for psychiatric problems during the prior year.
  • Report major psychiatric diagnoses and organic brain syndromes.
  • Report heart problems, chest pain, cancer within the last 5 years
  • Being treated by a therapist for psychological issues or problems with psychotropic medications.
  • Report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4-QF) (Cherpitel CJ, 2002).
  • Unwilling to change intake of beverages during the study period.
  • Plan to move from the area during the study period, and/or unable to attend monthly group meetings.
  • Report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home.
  • Report not being able to attend group meetings on Monday or Tuesday evenings.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy Choices
Behavioral: Healthy Choices
Multiple healthy choices presented with self-selection of choices used
Experimental: Diet Substitution A
Behavioral: Dietary substitution A
Substitution of calorie-dense item with lower calorie choice A
Experimental: Diet Substitution B
Behavioral: Dietary Substitution B
Substitution of calorie-dense item with lower calorie option B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change
Time Frame: 0, 3, 6 months
0, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
urine specific gravity
Time Frame: 0, 3, 6 months
0, 3, 6 months
fasting glucose
Time Frame: 0, 3, 6 months
0, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Nestle Waters North America, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (Estimate)

November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 1, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNC-Nestle-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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