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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

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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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