The Role of No-Calorie Beverages Within a Weight Loss Program
This study is ongoing, but not recruiting participants.
Sponsor:
University of Colorado, Denver
Collaborator:
Temple University
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01766700
First received: October 3, 2012
Last updated: April 3, 2013
Last verified: April 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 3, 2012 | ||||||||
| Last Updated Date | April 3, 2013 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. [ Time Frame: Data will be measured at 12 weeks. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01766700 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
This investigation is an equivalency trial to determine whether weight lost and maintained during the 1 year study differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers. [ Time Frame: Data will be collected at end of study. ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Role of No-Calorie Beverages Within a Weight Loss Program | ||||||||
| Official Title ICMJE | The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance | ||||||||
| Brief Summary | The no calorie drink study is looking for over 300 people to participate. The study is evaluating the effect of no calorie beverages on weight loss and weight maintained over time in people who drink diet beverages every day as compared to water only drinkers during the 1 year study period. |
||||||||
| Detailed Description | This investigation aims to test the hypothesis that the amount of weight lost and maintained over time in an intensive behavioral weight management program will be equivalent in subjects consuming beverages containing no calorie sweeteners as compared to water beverages. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
||||||||
| Condition ICMJE | Obesity | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | April 2014 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
|
||||||||
| Gender | Both | ||||||||
| Ages | 21 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01766700 | ||||||||
| Other Study ID Numbers ICMJE | 12-1063 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Colorado, Denver | ||||||||
| Study Sponsor ICMJE | University of Colorado, Denver | ||||||||
| Collaborators ICMJE | Temple University | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of Colorado, Denver | ||||||||
| Verification Date | April 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||