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

This study has been completed.
Sponsor:
Collaborator:
Nestle Waters North America, Inc
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01017783
First received: November 19, 2009
Last updated: August 1, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Obesity
 Behavioral: Dietary substitution A
Behavioral: Dietary Substitution B
Behavioral: Healthy Choices

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Weight change [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urine specific gravity [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017783

Locations
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
Principal Investigator: Deborah F Tate, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Deborah F. Tate, PhD, The University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT01017783     History of Changes
Other Study ID Numbers: UNC-Nestle-01
Study First Received: November 19, 2009
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013