The Role of No-Calorie Beverages Within a Weight Loss Program
The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance
1 other identifier
interventional
308
1 country
2
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.
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 Sep 2012
2 active sites
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
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 28, 2015
May 1, 2015
10 months
October 3, 2012
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Data will be measured at 12 weeks.
Secondary Outcomes (1)
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.
Data will be collected at end of study.
Study Arms (2)
No calorie beverages
EXPERIMENTAL2 no calorie beverages per day.
Water
ACTIVE COMPARATOR2 water beverages per day.
Interventions
Weekly and monthly lifestyle weight loss/maintenance classes.
Weekly and monthly lifestyle weight loss/maintenance classes.
Eligibility Criteria
You may qualify if:
- Body Mass Index: 27 - 40 kg/m2
- Must drink no calorie, sweetened drinks
You may not qualify if:
- Cardiovascular disease
- Uncontrolled blood pressure
- Smoker
- Medications that affecting metabolism
- Oral steroids
- History of stroke or seizures
- Thyroid disease
- Type 1 or 2 diabetes
- Cushings syndrome
- Renal disease
- Liver disease
- Cancer in the past 5 years
- HIV
- Active tuberculosis
- Major psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Temple Universitycollaborator
Study Sites (2)
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, 80022, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Related Publications (1)
Peters JC, Wyatt HR, Foster GD, Pan Z, Wojtanowski AC, Vander Veur SS, Herring SJ, Brill C, Hill JO. The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program. Obesity (Silver Spring). 2014 Jun;22(6):1415-21. doi: 10.1002/oby.20737.
PMID: 24862170DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Hill, PhD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Gary Foster, PhD
Temple University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
January 11, 2013
Study Start
September 1, 2012
Primary Completion
July 1, 2013
Study Completion
August 1, 2014
Last Updated
May 28, 2015
Record last verified: 2015-05