- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820403
Portion Size Effects on Body Weight:Free Living Setting
October 30, 2019 updated by: University of Minnesota
Portion Size Effects on Body Weight: Free Living Setting
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
233
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: portion size small
400 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
|
Other Names:
|
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Experimental: portion size medium
800 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
|
Other Names:
|
|
Experimental: portion size large
1600 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.
|
Other Names:
|
|
No Intervention: control
no box lunch provided to participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body weight change
Time Frame: six months
|
change in body weight from baseline to six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dietary energy intake
Time Frame: six months
|
change in energy intake from baseline to six months
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
March 25, 2013
First Submitted That Met QC Criteria
March 25, 2013
First Posted (Estimate)
March 28, 2013
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWA00000312-3
- R01DK081714 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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