Completed

Portion Size Effects on Body Weight: Free Living Setting

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What is being tested

portion size kcal of box lunch

+ portion size kcal of box lunch

+ portion size kcal of box lunch

Other
Who is being recruted

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2010
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: November 1, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01820403
Principal SponsorUniversity of Minnesota
Last updated: November 1, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

233 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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 -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
400 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.

Group II

Experimental
800 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.

Group III

Experimental
1600 kcal box lunch was delivered each weekday to each participant at the worksite for a six month period.

Group IV

No Intervention
no box lunch provided to participants.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Minnesota

Minneapolis, United StatesOpen University of Minnesota in Google Maps
CompletedOne Study Center