This study is testing the efficacy of the integrative approach to:
Condition or disease | Intervention/treatment | Phase |
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Health Behavior | Behavioral: Hip Hop Nutrition-Math Curriculum Behavioral: Food Explorers Program | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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Experimental: Group 2: Hip Hop Nutrition-Math Curriculum
The intervention group will receive an tailored program for ten weeks, meeting twice a week.
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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
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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.
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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
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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.
Ages Eligible for Study: | 9 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Luisa G Chan, M.A. | 212-342-3668 | Lg2063@columbia.edu | |
Contact: Vanessa Sawyer, RD | 860-881-3881 | vs2360@cumc.columbia.edu |
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 |
Principal Investigator: | Olajide Williams, MD | Columbia University |
Tracking Information | |||||||||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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.
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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:
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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. |
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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 |
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Condition ICMJE | Health Behavior | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 9 Years to 12 Years (Child) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Olajide Williams, Columbia University | ||||||||
Study Sponsor ICMJE | Columbia University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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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 |