Trial Outcomes & Findings for Effect of Nutrition Labeling on Fast Food Choices (NCT NCT00127660)

NCT ID: NCT00127660

Last Updated: 2017-09-01

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

605 participants

Primary outcome timeframe

single study visit

Results posted on

2017-09-01

Participant Flow

Participant milestones

Participant milestones
Measure
Menu: Calories=Yes, Value Pricing=no
Calories listed on menu, but value pricing was not in place.
Menu: Calories=Yes, Value Pricing = Yes
Calories listed on menu, value pricing in place.
Menu: Calories=no, Value Pricing = no
Calories not listed on menu, value pricing not in place
Menu: Calories=no, Value Pricing = Yes
CONTROL CONDITION: calories not listed on menu, value pricing in place.
Overall Study
STARTED
153
154
148
150
Overall Study
COMPLETED
150
151
143
150
Overall Study
NOT COMPLETED
3
3
5
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Menu: Calories=Yes, Value Pricing=no
Calories listed on menu, but value pricing was not in place.
Menu: Calories=Yes, Value Pricing = Yes
Calories listed on menu, value pricing in place.
Menu: Calories=no, Value Pricing = no
Calories not listed on menu, value pricing not in place
Menu: Calories=no, Value Pricing = Yes
CONTROL CONDITION: calories not listed on menu, value pricing in place.
Overall Study
Protocol Violation
3
3
5
0

Baseline Characteristics

Effect of Nutrition Labeling on Fast Food Choices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Menu: Calories=Yes, Value Pricing=no
n=150 Participants
Calories listed on menu, but value pricing was not in place.
Menu: Calories=Yes, Value Pricing = Yes
n=151 Participants
Calories listed on menu, value pricing in place.
Menu: Calories=no, Value Pricing = no
n=143 Participants
Calories not listed on menu, value pricing not in place
Menu: Calories=no, Value Pricing = Yes
n=150 Participants
CONTROL CONDITION: calories not listed on menu, value pricing in place.
Total
n=594 Participants
Total of all reporting groups
Age, Categorical
<=18 years
32 Participants
n=5 Participants
30 Participants
n=7 Participants
45 Participants
n=5 Participants
40 Participants
n=4 Participants
147 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
95 Participants
n=5 Participants
92 Participants
n=7 Participants
80 Participants
n=5 Participants
96 Participants
n=4 Participants
363 Participants
n=21 Participants
Age, Categorical
>=65 years
23 Participants
n=5 Participants
29 Participants
n=7 Participants
18 Participants
n=5 Participants
14 Participants
n=4 Participants
84 Participants
n=21 Participants
Sex: Female, Male
Female
81 Participants
n=5 Participants
94 Participants
n=7 Participants
89 Participants
n=5 Participants
89 Participants
n=4 Participants
353 Participants
n=21 Participants
Sex: Female, Male
Male
69 Participants
n=5 Participants
57 Participants
n=7 Participants
54 Participants
n=5 Participants
61 Participants
n=4 Participants
241 Participants
n=21 Participants
Region of Enrollment
United States
150 participants
n=5 Participants
151 participants
n=7 Participants
143 participants
n=5 Participants
150 participants
n=4 Participants
594 participants
n=21 Participants

PRIMARY outcome

Timeframe: single study visit

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After meal

energy content of meal ordered and consumed.

Outcome measures

Outcome measures
Measure
Menu: Calories=Yes, Value Pricing=no
n=150 Participants
Calories listed on menu, but value pricing was not in place.
Menu: Calories=Yes, Value Pricing = Yes
n=151 Participants
Calories listed on menu, value pricing in place.
Menu: Calories=no, Value Pricing = no
n=143 Participants
Calories not listed on menu, value pricing not in place
Menu: Calories=no, Value Pricing = Yes
n=150 Participants
CONTROL CONDITION: calories not listed on menu, value pricing in place.
Energy Intake
842.3 kcal/meal
Standard Deviation 425.3
873.6 kcal/meal
Standard Deviation 439.1
881.7 kcal/meal
Standard Deviation 353.6
827.5 kcal/meal
Standard Deviation 400.6

Adverse Events

Menu: Calories=Yes, Value Pricing=no

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Menu: Calories=Yes, Value Pricing = Yes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Menu: Calories=no, Value Pricing = no

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Menu: Calories=no, Value Pricing = Yes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Harnack, DrPH

University of Minnesota

Phone: 612-626-9398

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place