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Completed

NCT Number: NCT01820403

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.

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Key information

Conditions

Portion Sizes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

portion size kcal of box lunch

Other

Other names: 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 outcomes

  1. body weight change

    Time frame: six months

    change in body weight from baseline to six months

Secondary outcomes

  1. dietary energy intake

    Time frame: six months

    change in energy intake from baseline to six months

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Portion Size Effects on Body Weight: Free Living Setting

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2013
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.