Portion Size Effects on Body Weight:Free Living Setting
Primary Purpose
Portion Sizes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
portion size kcal of box lunch
Sponsored by
About this trial
This is an interventional prevention trial for Portion Sizes
Eligibility Criteria
Inclusion Criteria:
- : 1) age 18-60 yrs; 2) nonsmoker; 3) fluent in English; 4) not taking medications that affect appetite or body weight; 5) work at the medical complex full time, including during the lunch hours; 6) not allergic to the foods in the study lunches; 7) willing to eat the foods in the study lunches [examples were provided of the types of foods]; 8) not currently on a diet to lose weight; 9) no history of a diagnosed eating disorder; 10) not moving from the area during the next six months; 11) not currently taking part in another research study; 12) not currently pregnant, nursing or pregnant in the last 12 months.
Exclusion Criteria: if the person does not meet the criteria above
-
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
portion size small
portion size medium
portion size large
control
Arm Description
400 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
800 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
1600 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
no box lunch provided to participants.
Outcomes
Primary Outcome Measures
body weight change
change in body weight from baseline to six months
Secondary Outcome Measures
dietary energy intake
change in energy intake from baseline to six months
Full Information
NCT ID
NCT01820403
First Posted
March 25, 2013
Last Updated
October 30, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01820403
Brief Title
Portion Size Effects on Body Weight:Free Living Setting
Official Title
Portion Size Effects on Body Weight: Free Living Setting
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study purpose was to evaluate the effects of portion sizes on body weight and energy intake in a free-living setting. 223 healthy adults were recruited from an urban worksite and randomized to one of four groups for a six-month period. The groups were: 1) 400 kcal box lunch; 2) 800 kcal box lunch; 3) 1600 kcal box lunch; or 4) no box lunch. Participants were required to pick up a box lunch every week day for six months. Control participants did not receive a box lunch and were instructed to eat their usual lunch. Participants were weighed and dietary intake measured at baseline, one, three and six months. It was hypothesized that at six months, participants in the 1600 kcal box lunch would gain more weight and have higher energy intake than those in the other groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portion Sizes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
portion size small
Arm Type
Experimental
Arm Description
400 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
Arm Title
portion size medium
Arm Type
Experimental
Arm Description
800 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
Arm Title
portion size large
Arm Type
Experimental
Arm Description
1600 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
Arm Title
control
Arm Type
No Intervention
Arm Description
no box lunch provided to participants.
Intervention Type
Other
Intervention Name(s)
portion size kcal of box lunch
Other Intervention Name(s)
box lunches of different portion sizes were provided to participants each weekday for six months. Portion size conditions were 440 kcal, 800 kcal or 1600 kcal.
Primary Outcome Measure Information:
Title
body weight change
Description
change in body weight from baseline to six months
Time Frame
six months
Secondary Outcome Measure Information:
Title
dietary energy intake
Description
change in energy intake from baseline to six months
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
: 1) age 18-60 yrs; 2) nonsmoker; 3) fluent in English; 4) not taking medications that affect appetite or body weight; 5) work at the medical complex full time, including during the lunch hours; 6) not allergic to the foods in the study lunches; 7) willing to eat the foods in the study lunches [examples were provided of the types of foods]; 8) not currently on a diet to lose weight; 9) no history of a diagnosed eating disorder; 10) not moving from the area during the next six months; 11) not currently taking part in another research study; 12) not currently pregnant, nursing or pregnant in the last 12 months.
Exclusion Criteria: if the person does not meet the criteria above
-
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
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Portion Size Effects on Body Weight:Free Living Setting
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