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

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ClinicalTrials.gov Identifier: NCT01017783
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : August 3, 2011
Sponsor:
Collaborator:
Nestle Waters North America, Inc
Information provided by:
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Dietary substitution A Behavioral: Dietary Substitution B Behavioral: Healthy Choices Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Weight change [ Time Frame: 0, 3, 6 months ]

Secondary Outcome Measures :
  1. urine specific gravity [ Time Frame: 0, 3, 6 months ]
  2. fasting glucose [ Time Frame: 0, 3, 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017783


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7294
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Nestle Waters North America, Inc
Investigators
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Principal Investigator: Deborah F Tate, PhD University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Deborah F. Tate, PhD, The University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT01017783    
Other Study ID Numbers: UNC-Nestle-01
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight