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CompletedNCT03892733Updated Mar 27, 2019

Improving the Impact of Calorie Labeling Policies

An interventional study of calorie health education knowledge and skills in Obesity and Diet Habit, sponsored by New York City Health and Hospitals Corporation. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-27.

Sponsored by New York City Health and Hospitals Corporation · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 years 11 months after the study started (first participant enrolled Apr 2012, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Increased consumption of fast-food may be a contributing factor to the obesity epidemic. Posting calories on menus in fast-food restaurants is an important public health initiative and may help consumers to make lower calorie, healthier choices. This study will develop and test an intervention to improve the impact of calorie labeling policies. Further, the study will examine potential barriers to using posted calorie information

Read the detailed description

By the year 2030, 50% of American adults could be obese. Increasingly, Americans are consuming more foods away from home and most of these foods are consumed in fast-food restaurants. Menu calorie labeling provides calorie information at the point of purchase in fast-food restaurants and is one strategy employed to promote lower calorie, healthier food choices. Initial studies of the impact of calorie labeling, however, suggest that posting calories may only affect calories purchased in a minority of consumers.

The Patient Protection and Affordable Care Act (PPACA) mandates that calorie labeling be implemented nationally and fast-food restaurants throughout the U.S. will begin to post calorie information. With an overarching goal of improving the impact of calorie labeling policies; this proposal will develop and pilot test a brief intervention that is complementary to the posted calorie information, and will explore potential barriers to reducing calories among an urban clinic population. The study aims are: (Aim 1) To develop the Complementary Calorie Labeling (CCL) intervention, an individual single-session intervention that can be delivered in primary care settings. Semi-structured interviews will be conducted among 40 overweight or obese participants to guide development of intervention components and materials. (Aim 2) To conduct a pilot randomized controlled trial of the CCL intervention among 188 overweight or obese participants. The CCL intervention will be compared to a control group that receives an educational brochure about calories. The primary outcome will be weekly calories purchased at fast-food restaurants as measured by fast-food receipts and food logs. (Aim 3) To examine whether calorie knowledge, health literacy, numeracy, and motivation are barriers to using calorie information and whether these variables moderate intervention efficacy.

The proposed study will be conducted in a primarily low-income, minority clinic population in the Bronx NYC. NYC was the first major city to implement calorie labeling. Preliminary data from NYC suggest that fast-food consumers in the Bronx may be less likely to reduce their calories purchased when calorie information is posted, compared to other consumers in NYC. Developing interventions that may improve the impact of calorie labeling policies within this population will have important implications as these policies are implemented in urban communities throughout the U.S.

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Conditions studied

  • Obesity
  • Diet Habit
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In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 145 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

New York City Health and Hospitals Corporation is the lead sponsor of 28 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Eats at Fast-food restaurant at least once per week BMI>25

Exclusion criteria

Exclusion Criteria:

  • inability to keep food logs or fast-food receipts
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    Intervention

    CHEKS (calorie health, education, knowledge and skills) intervention will educate participants about calories in fast-food and teach skills to select lower calorie fast-food items.

    Behavioral: calorie health education knowledge and skills

  • No intervention
    Control

    Participants will receive a brochure about healthier choices in fast-food restaurants.

Interventions

  • Behavioralcalorie health education knowledge and skills

    45 minute intervention done by health educator to give participants skills to use calorie information posted in fast-food restaurants

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What researchers measure

Primary outcomes

  1. fast-food calories per week

    change in fast-food calories purchased

    Time frame: 4 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03892733
Lead sponsor
New York City Health and Hospitals Corporation
Responsible party
Sponsor
First posted
Mar 27, 2019
Start date
Apr 1, 2012
Primary completion
Mar 31, 2014
Completion
Mar 31, 2015
Last update
Mar 27, 2019

Study contacts

Nichola Davis
principal investigator · New York City Health and Hospitals Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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