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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017783
• Other study ID #: UNC-Nestle-01
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: August 1, 2011
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: August 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Dietary substitution A
Substitution of calorie-dense item with lower calorie choice A
• Dietary Substitution B
Substitution of calorie-dense item with lower calorie option B
• Healthy Choices
Multiple healthy choices presented with self-selection of choices used

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Nestle Waters North America, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change		0, 3, 6 months	No
Secondary	urine specific gravity		0, 3, 6 months	No
Secondary	fasting glucose		0, 3, 6 months	No