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Tracking Information | |||||
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First Received Date † | May 19, 2006 | ||||
Last Updated Date | January 14, 2009 | ||||
Start Date † | July 2006 | ||||
Current Primary Outcome Measures † |
Weight loss [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00328744 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Reducing Snack Variety in Weight Loss Treatment | ||||
Official Title † | Reducing Snack Food Variety During Obesity Treatment | ||||
Brief Summary | The rising prevalence of obesity in the United States is believed to be due to increased exposure to adverse environmental factors, such as food portion sizes and increased dietary variety. Although decreasing portion sizes is a strategy used in weight loss programs, research has not studied the effects of decreasing dietary variety. Cross-sectional studies show a positive association between variety and body weight and in our own studies the investigators have shown that greater reductions in the number of different snack foods (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake and greater weight loss. Limiting variety may reduce intake through long-term sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary approach with the potential to improve long-term weight loss, which has not been studied as a clinical strategy in obesity research. The objective of this application is to conduct a randomized controlled trial of a behavioral weight loss intervention limiting the number of different snack foods consumed. Two hundred overweight and obese participants will be randomized to a standard behavioral intervention (Standard) or to a standard behavioral intervention that also limits the number of different snack foods consumed (Limited Variety). Both conditions will receive an 18-month standard behavioral intervention, using behavioral techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited Variety condition will also limit variety in snack foods to only two chosen snack foods throughout the intervention. Measures of weight, snack food consumption and hedonics, and diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will determine:
Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake. To date, there is no dietary prescription that has been tested that capitalizes on the effect of variety on intake that can be maintained. This will be the first investigation to examine methods of manipulating dietary variety that can be adhered to over time and that influence intake, weight loss, and weight loss maintenance. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Obesity | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Estimated Enrollment † | 200 | ||||
Estimated Completion Date | March 2011 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
A BMI of > 27 was chosen as eligibility criteria for this investigation because this level of BMI will allow for a 10% weight loss to occur prior to reaching a BMI of < 25. Individuals with a BMI of > 45 have more medical co-morbidities and require greater medical supervision, and thus will be considered ineligible for this investigation. Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years to 65 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00328744 | ||||
Responsible Party | Hollie Raynor, Ph.D., R.D., University of Tennessee | ||||
Secondary IDs †† | |||||
Study Sponsor † | The Miriam Hospital | ||||
Collaborators †† | National Institutes of Health (NIH) | ||||
Investigators † |
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Information Provided By | The Miriam Hospital | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |