Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary substitution A
Dietary Substitution B
Healthy Choices
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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.
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Healthy Choices
Diet Substitution A
Diet Substitution B
Arm Description
Outcomes
Primary Outcome Measures
Weight change
Secondary Outcome Measures
urine specific gravity
fasting glucose
Full Information
NCT ID
NCT01017783
First Posted
November 19, 2009
Last Updated
August 1, 2011
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Nestle Waters North America, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01017783
Brief Title
Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Official Title
Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Nestle Waters North America, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Choices
Arm Type
Other
Arm Title
Diet Substitution A
Arm Type
Experimental
Arm Title
Diet Substitution B
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Dietary substitution A
Intervention Description
Substitution of calorie-dense item with lower calorie choice A
Intervention Type
Behavioral
Intervention Name(s)
Dietary Substitution B
Intervention Description
Substitution of calorie-dense item with lower calorie option B
Intervention Type
Behavioral
Intervention Name(s)
Healthy Choices
Intervention Description
Multiple healthy choices presented with self-selection of choices used
Primary Outcome Measure Information:
Title
Weight change
Time Frame
0, 3, 6 months
Secondary Outcome Measure Information:
Title
urine specific gravity
Time Frame
0, 3, 6 months
Title
fasting glucose
Time Frame
0, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah F Tate, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23364015
Citation
Piernas C, Tate DF, Wang X, Popkin BM. Does diet-beverage intake affect dietary consumption patterns? Results from the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2013 Mar;97(3):604-11. doi: 10.3945/ajcn.112.048405. Epub 2013 Jan 30.
Results Reference
derived
PubMed Identifier
22301929
Citation
Tate DF, Turner-McGrievy G, Lyons E, Stevens J, Erickson K, Polzien K, Diamond M, Wang X, Popkin B. Replacing caloric beverages with water or diet beverages for weight loss in adults: main results of the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2012 Mar;95(3):555-63. doi: 10.3945/ajcn.111.026278. Epub 2012 Feb 1. Erratum In: Am J Clin Nutr. 2013 Dec;98(6):1599.
Results Reference
derived
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Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
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