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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03952754
Other study ID # AAAR5173
Secondary ID 5R01NR017571
Status Recruiting
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date June 2025

Study information

Verified date May 2024
Source Columbia University
Contact Gabriela I. Drucker, MS
Phone 212-342-3668
Email gid2106@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is testing the efficacy of the integrative approach to: 1. teach 5th grade children menu board calorie literacy as measured by our novel recently validated menu board calorie literacy (MBCL) instrument; 2. provide strategies designed to improve food purchasing behaviors; and 3. facilitate the transmission of core lesson messages from children to parents via a procedure that we have termed "Child Mediated Health Communication (CMHC)".


Description:

Data show that nearly 25% of children aged four to eight years consumed fast food on a typical day. These trends in fast food consumption are more acute among low-income urban dwellers where higher rates of overweight and childhood obesity are seen. This has led to a focus on providing fast food consumers with point-of-purchase nutrition information, such as the calorie posting mandates, in the hopes that these decision cues will help consumers make better informed dietary decisions. Most children chose their own meals at the point-of-purchase. It is clear that additional strategies are needed to encourage the point-of-purchase use of calorie postings, however available studies provide little insight into best practices or the types of approaches needed. It is with this in mind that the investigator developed a school-based approach to improve point-of purchase use of calorie postings, by creating a novel intervention that targets menu board calorie literacy as a means of improving food-purchasing behaviors. Hip Hop Nutrition-Math Curriculum is a novel behaviorally focused multimedia, musical school health rap toolkit that targets what we refer to as menu board calorie literacy. 4th grade common core math standards are integrated into the program in a manner that incorporates evidence-based nutrition education recommendations by the Institute of Medicine and the Centers for Disease Control and Prevention (CDC). The investigator proposes to test the efficacy of the integrative approach on food purchasing behaviors of children in an adequately powered, controlled trial. The investigator will test the intervention in the after-school setting among economically disadvantaged children and incorporate parental engagement in our outcome evaluations. There is a partnership with New York City's largest after-school program vendor, New York Edge (formerly called Sports and Arts in Schools foundation/SASF), for the implementation of this study. The goal of a health literacy intervention is to improve health decision-making and/or behavior. For this reason, the investigator will measure both menu board calorie literacy and food choice behavior at a point-of-purchase.


Recruitment information / eligibility

Status Recruiting
Enrollment 560
Est. completion date June 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria: - 5th grade student participating in the New York Edge after school program Exclusion Criteria: - Absence of Internet access at home - No working phone line - Major psychiatric disability or medical condition that may affect participation (e.g., psychotic illness, terminal illness) - Non-English speaking students

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hip Hop Nutrition-Math Curriculum
This program teaches children skills needed to understand restaurant-menu boards, how to make healthy food choices, while reinforcing the common core math concepts they are learning in school. The program consists of: 2 lessons a week, of about 1 hour each lesson, for a total of 20 lessons.
Food Explorers Program
After-school program Food Explorers will represent "Usual Care". This program comprises food and exploration activities, familiarizing children with diverse foods, nutrition concepts, tasty recipes and physical activity.

Locations

Country Name City State
United States Columbia University Irving Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory Outcome Measures: BMI Percentiles The change in BMI percentiles from a high-index to low-index will indicate a change in BMI and program impact. Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up
Primary Number of students with positive behavior change at Food Sales Students will be tracked on the food purchases they make at "Food Sales" conducted through study.
Each child will be given an identifiable food voucher for use at the Food Sale. However, point-of-purchase behaviors will be assessed with the children unaware that their food choices being tracked. The food categories range from low calorie/nutrient to high.
A change from a purchase of a high-calorie/nutrient item to a low-calorie/nutrient item will indicate a positive behavior change.
Within Year5 of the study
Secondary Menu Board Calorie Literacy Score Content knowledge of students will be assessed by the total number of correct responses on the survey measures. Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up
Secondary Parental Nutritional Knowledge Score Nutrition knowledge score will be assessed using a 7-item questionnaire at Baseline, Immediately post intervention, and at 3-months post intervention. Changes in the composite score will be analyzed across each of the test sequences range of 0 - 7, with higher scores representing greater nutrition knowledge. Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up
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