Liking of Snack Foods - Sub-Study 1
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | February 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Amount of food eaten | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Liking of foods in study | ||||
| 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 | Liking of Snack Foods - Sub-Study 1 | ||||
| Official Title ICMJE | The Effect of Portion Size and Quantity of Food Provided on Intake | ||||
| Brief Summary | Specific Aims: Environmental factors contributing to overconsumption, such as larger food portion sizes, may be contributing to the obesity epidemic. The objective of the proposed study is to examine the independent and combined effects of portion size and quantity of food on intake in normal weight males and females. Participants will be randomly assigned to one of four conditions varying in the portion size and quantity of junk food provided: small quantity of food packaged in small portions (SSP), small quantity of food packaged in large portions (SLP), large quantity of food packaged in small portions (LSP), and large quantity of food packaged in large portions (LLP). A box containing four different junk foods, packaged according to one of the four conditions, will be given to participants to take home for three days. The total amount of food consumed from the box over the three days will be measured. It is anticipated that portion size and quantity of food, both independently and combined, will influence intake, such that larger portion sizes and quantity of food provided to participants will produce greater intake.Subject Population: We propose to recruit 60 healthy men and women, aged 18-50 years, with a body mass index (BMI) of less than or equal to 28. Participants will be non-smokers, unrestrained eaters, and have no known food allergies to the foods used in the investigation.Methods/Design: Participants will be randomly assigned to one of four conditions, varying in portion size (small versus large) and quantity of food provided (small versus large). A box containing four junk foods, packaged according to one of the conditions, will be provided to participants. They will be encouraged to eat as much or as little of the food as they want, but to at least taste each of the four foods over the three-day period. During this time, they will be instructed to not eat any other junk foods. At the end of the three-day period, participants will return the box with any remaining uneaten junk food.Data Analyses: The dependent variables, the amount of grams and kcals consumed from the provided junk foods, will be examined between the four different conditions.Significance: If portion size and quantity are related to intake, subsequent studies will develop clinical interventions related to reducing portion size and/or quantity of food available in the household. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: portion or unportioned food | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 32 | ||||
| Completion Date | March 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Healthy, non-smoking, normal- and over-weight (body mass index [BMI] < 30) unrestrained, males and females, who regularly eat junk foods (consume junk foods > 3 times per week). Exclusion Criteria: Participants will be excluded if they are not between the ages of 18 and 50, smoke, following a weight loss diet, an athlete in training, pregnant or breastfeeding, or have a health condition or use medication that affects eating or requires specialized diet therapy (e.g., diabetes). Additionally, if participants rarely consume junk foods (< 2 times per week) or have allergies or unfavorable preferences towards foods used in the investigation they will be excluded from the study. Participants will also be excluded if they are a restrained eater (scoring > 12 on the Three Factor Eating Questionnaire [TFEQ] [Stunkard & Messick, 1985]) or report being a binge eater.- |
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| Gender | Both | ||||
| Ages | 18 Years to 50 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 | NCT00200213 | ||||
| Other Study ID Numbers ICMJE | 2107-02 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | The Miriam Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Miriam Hospital | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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