Improving the Impact of Calorie Labeling Policies

Obesity Clinical Trial

Official title:

Improving the Impact of Calorie Labeling Policies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892733
• Other study ID #: 2011-579
• Status: Completed
• Phase: N/A
• Start date: April 1, 2012
• Est. completion date: March 31, 2015

Study information

• Verified date: March 2019
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 31, 2015
• Est. primary completion date: March 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• inability to keep food logs or fast-food receipts

Related Conditions & MeSH terms

• Diet Habit
• Obesity

Intervention

Behavioral:
• calorie 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York City Health and Hospitals Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fast-food calories per week	change in fast-food calories purchased	4 weeks