NCT03952754

Brief Summary

This study is testing the efficacy of the integrative approach to:

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

Trial Health

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Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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 Progress88%
Jan 2019Jun 2027

Study Start

First participant enrolled

January 7, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

8.2 years

First QC Date

May 11, 2019

Last Update Submit

June 10, 2025

Conditions

Keywords

NutritionHealthSchool Children

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Menu Board Calorie Literacy Score

    Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up

  • Parental Nutritional Knowledge Score

    Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up

Other Outcomes (1)

  • Exploratory Outcome Measures: BMI Percentiles

    Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up

Study Arms (2)

Group 2: Hip Hop Nutrition-Math Curriculum

EXPERIMENTAL

The intervention group will receive an tailored program for ten weeks, meeting twice a week.

Behavioral: Hip Hop Nutrition-Math Curriculum

Group 1: Food Explorers Program

ACTIVE COMPARATOR

The control group will receive the usual care for nutrition program provided by the schools, called Food Explorers. The group will also be conducted ten weeks, meeting twice a week.

Behavioral: Food Explorers Program

Interventions

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.

Also known as: Hip Hop Nutrition math-based education program
Group 2: Hip Hop Nutrition-Math Curriculum

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.

Also known as: Food Explorers Curriculum
Group 1: Food Explorers Program

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th grade student participating in the New York Edge after school program

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Olajide A. Williams, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

May 11, 2019

First Posted

May 16, 2019

Study Start

January 7, 2019

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations