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Do Weight Status and the Level of Dietary Restraint Moderate the Relationship Between Package Unit Size and Food Intake?

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Package Unit Size - Single Serving
Package Unit Size - Standard
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring normal weight, overweight, dietary restraint, package unit size, food intake

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and females aged 18-35 years old.
  • Body Mass Index (BMI) between 18.5-24.9 kg/m2 or BMI between 25-39.9 kg/m2.

    • For normal weight groups: BMI of 18.5-24.9 kg/m2.
    • For overweight groups: BMI of 25-39.9 kg/m2.
  • Dietary restraint scores of either less than or equal to 12 or > 12 on the Three Factor Eating Questionnaire-Cognitive Restraint scale (TFEQ-R) [10].

    • For unrestrained groups: less than or equal to 12.
    • For restrained groups: > 12.
  • Do not have unfavorable preference toward pretzels.
  • Do not have allergies to pretzel ingredients.
  • Do not have a health condition or use medication that affects eating or requires a therapeutic diet.
  • Must have a consistent schedule during the time of the study.
  • Must agree to instructions to not share pretzel snack packages with others.

Exclusion Criteria:

  • BMI below 18.5 or above 39.9 kg/m2.
  • Have an unfavorable preference toward pretzels.
  • Have allergies to pretzel ingredients (wheat flour).

    • Severe allergies to nuts - Synder's of Hanover pretzels are made in a facility that handles peanut butter.
  • Are unwilling to consume pretzels during the time of the study.
  • Are pregnant or breastfeeding.
  • Do not meet one or more of the other above mentioned eligibility requirements.

Sites / Locations

  • Healthy Eating and Activity Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Normal Weight, Unrestrained - Standard

Normal Weight, Restrained - Single Serving

Normal Weight, Restrained - Standard

Overweight, Unrestrained - Single Serving

Overweight, Unrestrained - Standard

Overweight, Restrained - Single Serving

Overweight, Restrained - Standard

Normal Weight, Unrestrained - Single Serving

Arm Description

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Outcomes

Primary Outcome Measures

Total grams of pretzels consumed.
Total grams of pretzels consumed by participants over the 4-day study period will be determined by subtracting pre- and post-consumption weight of snack packages provided.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2011
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
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1. Study Identification

Unique Protocol Identification Number
NCT01384552
Brief Title
Do Weight Status and the Level of Dietary Restraint Moderate the Relationship Between Package Unit Size and Food Intake?
Official Title
Do Weight Status and the Level of Dietary Restraint Moderate the Relationship Between Package Unit Size and Food Intake?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine the independent and combined effects of weight status and the level of dietary restraint on the relationship between package unit size and food intake.
Detailed Description
The estimated prevalence of obesity among adults in 2007-2008 was 33.8% and the combined estimated prevalence of overweight and obesity was 68.0% [1]. Although there are no clear reasons for the current obesity epidemic, there is a general consensus that environmental dietary factors, such as package unit size, encourage excessive food intake and positive energy balance [2, 3]. It is believed that the package unit size of food indirectly influences food intake by impacting the accuracy of consumption monitoring [2, 4]. Large packages decrease the accuracy of consumption monitoring by making it difficult to assess how many servings have been consumed in one sitting, while small single-serving packages can increase the accuracy of consumption monitoring by providing a clear definition of what a standard serving is and how much one has consumed [2, 4, 5]. Therefore, it has been proposed that small, single-serving packages of snack foods may help reduce energy intake [4, 5]. To date, limited studies have been conducted in this area and the results are inconsistent [4-9]. Mixed results could be related to differences in participant variables, specifically weight status and level of dietary restraint (a term that refers to the amount of control exerted over food intake) [4, 9]. These individual characteristics may interact with food package unit size to influence one's food intake [2, 4]. Overweight individuals or restrained eaters may more closely monitor the volume of food they consume as compared to normal weight or unrestrained eaters [4, 9]. The [smaller] size of food packaging may aid in monitoring food consumption and thus, influence how much food is consumed in overweight and/or restrained eaters [2, 4]. Therefore, the objective of this study is to determine if weight status and the level of dietary restraint moderate the relationship between package unit size and food intake. Specific Aims: Determine the effect of dietary restraint on the relationship between package unit size and food intake. Determine the effect of weight status on the relationship between package unit size and food intake. Determine the combined effect of weight status and dietary restraint on the relationship between package unit size and food intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
normal weight, overweight, dietary restraint, package unit size, food intake

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Weight, Unrestrained - Standard
Arm Type
Active Comparator
Arm Description
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Arm Title
Normal Weight, Restrained - Single Serving
Arm Type
Active Comparator
Arm Description
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Arm Title
Normal Weight, Restrained - Standard
Arm Type
Active Comparator
Arm Description
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Arm Title
Overweight, Unrestrained - Single Serving
Arm Type
Active Comparator
Arm Description
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Arm Title
Overweight, Unrestrained - Standard
Arm Type
Active Comparator
Arm Description
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Arm Title
Overweight, Restrained - Single Serving
Arm Type
Active Comparator
Arm Description
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Arm Title
Overweight, Restrained - Standard
Arm Type
Active Comparator
Arm Description
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Arm Title
Normal Weight, Unrestrained - Single Serving
Arm Type
Active Comparator
Arm Description
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Intervention Type
Other
Intervention Name(s)
Package Unit Size - Single Serving
Intervention Description
Participants will receive a box of twenty-two, 0.9-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Intervention Type
Other
Intervention Name(s)
Package Unit Size - Standard
Intervention Description
Participants will receive a box of two, 10-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Primary Outcome Measure Information:
Title
Total grams of pretzels consumed.
Description
Total grams of pretzels consumed by participants over the 4-day study period will be determined by subtracting pre- and post-consumption weight of snack packages provided.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and females aged 18-35 years old. Body Mass Index (BMI) between 18.5-24.9 kg/m2 or BMI between 25-39.9 kg/m2. For normal weight groups: BMI of 18.5-24.9 kg/m2. For overweight groups: BMI of 25-39.9 kg/m2. Dietary restraint scores of either less than or equal to 12 or > 12 on the Three Factor Eating Questionnaire-Cognitive Restraint scale (TFEQ-R) [10]. For unrestrained groups: less than or equal to 12. For restrained groups: > 12. Do not have unfavorable preference toward pretzels. Do not have allergies to pretzel ingredients. Do not have a health condition or use medication that affects eating or requires a therapeutic diet. Must have a consistent schedule during the time of the study. Must agree to instructions to not share pretzel snack packages with others. Exclusion Criteria: BMI below 18.5 or above 39.9 kg/m2. Have an unfavorable preference toward pretzels. Have allergies to pretzel ingredients (wheat flour). Severe allergies to nuts - Synder's of Hanover pretzels are made in a facility that handles peanut butter. Are unwilling to consume pretzels during the time of the study. Are pregnant or breastfeeding. Do not meet one or more of the other above mentioned eligibility requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie A Raynor, Ph.D.
Organizational Affiliation
University of Tennessee, Knoxville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chrystal L Haire, B.S.
Organizational Affiliation
University of Tennessee, Knoxville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Eating and Activity Laboratory
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20071471
Citation
Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.
Results Reference
background
PubMed Identifier
11274524
Citation
French SA, Story M, Jeffery RW. Environmental influences on eating and physical activity. Annu Rev Public Health. 2001;22:309-35. doi: 10.1146/annurev.publhealth.22.1.309.
Results Reference
background
PubMed Identifier
15189128
Citation
Wansink B. Environmental factors that increase the food intake and consumption volume of unknowing consumers. Annu Rev Nutr. 2004;24:455-79. doi: 10.1146/annurev.nutr.24.012003.132140.
Results Reference
background
PubMed Identifier
17890500
Citation
Raynor HA, Wing RR. Package unit size and amount of food: do both influence intake? Obesity (Silver Spring). 2007 Sep;15(9):2311-9. doi: 10.1038/oby.2007.274.
Results Reference
background
PubMed Identifier
19501784
Citation
Stroebele N, Ogden LG, Hill JO. Do calorie-controlled portion sizes of snacks reduce energy intake? Appetite. 2009 Jun;52(3):793-796. doi: 10.1016/j.appet.2009.02.015. Epub 2009 Mar 6.
Results Reference
background
PubMed Identifier
15010185
Citation
Devitt AA, Mattes RD. Effects of food unit size and energy density on intake in humans. Appetite. 2004 Apr;42(2):213-20. doi: 10.1016/j.appet.2003.10.003.
Results Reference
background
PubMed Identifier
19857636
Citation
Raynor HA, Van Walleghen EL, Niemeier H, Butryn ML, Wing RR. Do food provisions packaged in single-servings reduce energy intake at breakfast during a brief behavioral weight-loss intervention? J Am Diet Assoc. 2009 Nov;109(11):1922-5. doi: 10.1016/j.jada.2009.08.009.
Results Reference
background
PubMed Identifier
20035274
Citation
Freedman MR, Brochado C. Reducing portion size reduces food intake and plate waste. Obesity (Silver Spring). 2010 Sep;18(9):1864-6. doi: 10.1038/oby.2009.480. Epub 2009 Dec 24.
Results Reference
background
PubMed Identifier
21233814
Citation
Wansink B, Payne CR, Shimizu M. The 100-calorie semi-solution: sub-packaging most reduces intake among the heaviest. Obesity (Silver Spring). 2011 May;19(5):1098-100. doi: 10.1038/oby.2010.306. Epub 2011 Jan 13.
Results Reference
background
PubMed Identifier
3981480
Citation
Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
Results Reference
background
Links:
URL
http://heal.utk.edu/
Description
This is the website for the Healthy Eating and Activity Laboratory (HEAL), where this study is being conducted.

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Do Weight Status and the Level of Dietary Restraint Moderate the Relationship Between Package Unit Size and Food Intake?

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