Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
1 other identifier
interventional
318
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 19, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedAugust 3, 2011
August 1, 2011
1.8 years
November 19, 2009
August 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Weight change
0, 3, 6 months
Secondary Outcomes (2)
urine specific gravity
0, 3, 6 months
fasting glucose
0, 3, 6 months
Study Arms (3)
Healthy Choices
OTHERDiet Substitution A
EXPERIMENTALDiet Substitution B
EXPERIMENTALInterventions
Substitution of calorie-dense item with lower calorie choice A
Substitution of calorie-dense item with lower calorie option B
Multiple healthy choices presented with self-selection of choices used
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7294, United States
Related Publications (2)
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.
PMID: 23364015DERIVEDTate 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.
PMID: 22301929DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah F Tate, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 19, 2009
First Posted
November 23, 2009
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
August 3, 2011
Record last verified: 2011-08