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| Sponsors and Collaborators: |
The Miriam Hospital National Institutes of Health (NIH) |
| Information provided by: | The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT00328744 |
Purpose
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 we 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: 1) if the Limited Variety condition produces greater weight loss than the Standard condition at 18 months; 2) if the Limited Variety condition consumes fewer servings and calories from snack foods than the Standard condition; and 3) if limiting snack food variety produces long-term sensory-specific satiety and/or monotony. 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.
| Condition | Intervention |
|
Obesity |
Behavioral: Behavioral weight loss |
| MedlinePlus related topics: | Obesity Weight Control |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Reducing Snack Food Variety During Obesity Treatment |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | March 2011 |
| Arms | Assigned Interventions |
|
1: Experimental
Behavioral: Behavioral weight loss (Standard)
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Behavioral: Behavioral weight loss
Behavioral weight loss
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2: Experimental
Behavioral: Behavioral weight loss (Limited Variety)
|
Behavioral: Behavioral weight loss
Behavioral weight loss
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Eligibility
| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Body mass index (BMI) between 27 and 45 kg/m2. Based upon the Evidence Report (72), weight loss is recommended for individuals with a BMI > 25. 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.
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Exclusion Criteria:
Consume < 5 different types of snack food per week. Pilot data indicated that upon screening 44 participants, mean weekly variety of snack foods was 8.7 (range 2 to 14, with only two participants consuming < 5 snack foods per week).
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Contacts and Locations| Contact: Hollie Raynor, PhD | 865-974-6259 | hraynor@utk.edu |
| United States, Rhode Island | |||||
| The Miriam Hospital | Recruiting | ||||
| Providence, Rhode Island, United States, 02903 | |||||
| Contact: Hollie Raynor, PhD 865-974-6259 hraynor@utk.edu | |||||
| Principal Investigator: Hollie Raynor, PhD | |||||
| The Miriam Hospital |
| National Institutes of Health (NIH) |
| Principal Investigator: | Hollie Raynor, PhD | University of Tennessee |
More Information
| Responsible Party: | University of Tennessee ( Hollie Raynor, Ph.D., R.D. ) |
| Study ID Numbers: | R01-DK074721-01 |
| First Received: | May 19, 2006 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00328744 |
| Health Authority: | United States: Food and Drug Administration |
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