The Role of No-Calorie Beverages Within a Weight Loss Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: 2 no calorie beverages per day
* Behavioral: 2 water beverages per day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index: 27 - 40 kg/m2 Must drink no calorie, sweetened drinks Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No calorie beverages<br>2 no calorie beverages per day. | Behavioral: 2 no calorie beverages per day<br>* Weekly and monthly lifestyle weight loss/maintenance classes.<br>* Other names: 2 non-nutritive sweetened beverages per day;|
| Active Comparator: Water<br>2 water beverages per day. | Behavioral: 2 water beverages per day<br>* Weekly and monthly lifestyle weight loss/maintenance classes.<br>* Other names: water only group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, weight loss, weight maintenance