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出境医 / 临床实验 / Effect of Hip Hop Nutrition-Math Curriculum

Effect of Hip Hop Nutrition-Math Curriculum

Study Description
Brief 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)".

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Hip Hop Nutrition-Math Curriculum Behavioral: Food Explorers Program Not Applicable

Detailed 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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of an Integrated Nutrition-math Curriculum to Improve Food-purchasing Behavior of Children
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Group 2: Hip Hop Nutrition-Math Curriculum
The intervention group will receive an tailored program for ten weeks, meeting twice a week.
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.
Other Name: Hip Hop Nutrition math-based education program

Active Comparator: Group 1: Food Explorers Program
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
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.
Other Name: Food Explorers Curriculum

Outcome Measures
Primary Outcome Measures :
  1. Number of students with positive behavior change at Food Sales [ Time Frame: Within Year5 of the study ]

    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.



Secondary Outcome Measures :
  1. Menu Board Calorie Literacy Score [ Time Frame: Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up ]
    Content knowledge of students will be assessed by the total number of correct responses on the survey measures.

  2. Parental Nutritional Knowledge Score [ Time Frame: Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up ]
    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.


Other Outcome Measures:
  1. Exploratory Outcome Measures: BMI Percentiles [ Time Frame: Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up ]
    The change in BMI percentiles from a high-index to low-index will indicate a change in BMI and program impact.


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
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Contact: Luisa G Chan, M.A. 212-342-3668 Lg2063@columbia.edu
Contact: Vanessa Sawyer, RD 860-881-3881 vs2360@cumc.columbia.edu

Locations
Layout table for location information
United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Luisa G Chan, MA    212-342-3668    lg2063@columbia.edu   
Sub-Investigator: James M Noble, MD         
Sub-Investigator: John Rausch, MD         
Principal Investigator: Olajide Williams, MD         
Sponsors and Collaborators
Columbia University
Investigators
Layout table for investigator information
Principal Investigator: Olajide Williams, MD Columbia University
Tracking Information
First Submitted Date  ICMJE May 11, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date January 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Number of students with positive behavior change at Food Sales [ Time Frame: Within Year5 of the study ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Menu Board Calorie Literacy Score [ Time Frame: Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up ]
    Content knowledge of students will be assessed by the total number of correct responses on the survey measures.
  • Parental Nutritional Knowledge Score [ Time Frame: Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2019)
Exploratory Outcome Measures: BMI Percentiles [ Time Frame: Baseline, Post-Intervention (approximately 10 Weeks), 3-Month Follow Up ]
The change in BMI percentiles from a high-index to low-index will indicate a change in BMI and program impact.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Hip Hop Nutrition-Math Curriculum
Official Title  ICMJE Effect of an Integrated Nutrition-math Curriculum to Improve Food-purchasing Behavior of Children
Brief 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)".
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Health Behavior
Intervention  ICMJE
  • 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.
    Other Name: Hip Hop Nutrition math-based education program
  • Behavioral: 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.
    Other Name: Food Explorers Curriculum
Study Arms  ICMJE
  • Experimental: Group 2: Hip Hop Nutrition-Math Curriculum
    The intervention group will receive an tailored program for ten weeks, meeting twice a week.
    Intervention: Behavioral: Hip Hop Nutrition-Math Curriculum
  • Active Comparator: Group 1: Food Explorers Program
    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.
    Intervention: Behavioral: Food Explorers Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
560
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date January 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Luisa G Chan, M.A. 212-342-3668 Lg2063@columbia.edu
Contact: Vanessa Sawyer, RD 860-881-3881 vs2360@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952754
Other Study ID Numbers  ICMJE AAAR5173
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Olajide Williams, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olajide Williams, MD Columbia University
PRS Account Columbia University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP