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OpenTrials
Completed

NCT Number: NCT01017783

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary substitution A

Behavioral

Substitution of calorie-dense item with lower calorie choice A

Dietary Substitution B

Behavioral

Substitution of calorie-dense item with lower calorie option B

Healthy Choices

Behavioral

Multiple healthy choices presented with self-selection of choices used

Primary outcomes

  1. Weight change

    Time frame: 0, 3, 6 months

Secondary outcomes

  1. urine specific gravity

    Time frame: 0, 3, 6 months

  2. fasting glucose

    Time frame: 0, 3, 6 months

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Nestle Waters North America, Inc

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 23, 2009
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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