NCT03892733

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 15, 2019

Last Update Submit

March 25, 2019

Conditions

ObesityDiet Habit

Outcome Measures

Primary Outcomes (1)

  • fast-food calories per week

    change in fast-food calories purchased

    4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

calorie health education knowledge and skillsBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • inability to keep food logs or fast-food receipts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Nichola Davis

    New York City Health and Hospitals Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 27, 2019

Study Start

April 1, 2012

Primary Completion

March 31, 2014

Study Completion

March 31, 2015

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share