NCT03284112

Brief Summary

The purpose of this research study is to evaluate the knowledge of parents and children with respect to dementia symptoms, risk factors, and response before and after an interactive dementia education program that uses music and dance to enhance a health education curriculum at 1-week and 3-months after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

September 18, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 23, 2025

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

4.8 years

First QC Date

September 12, 2017

Results QC Date

September 12, 2025

Last Update Submit

October 8, 2025

Conditions

Keywords

Dementia, Schools, Nutrition, Health

Outcome Measures

Primary Outcomes (1)

  • OSHH Program Effectiveness of Educating Parents at 1-week and 3-months After the Intervention Using ASK-AD 7

    OSHH Program effectiveness of educating parents at 1-week post and 3-months post intervention using a 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions). Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome.

    Baseline (1 week up to 15 weeks prior to Intervention Day 1), 1-week post-intervention (1 week up to 13 weeks post-Intervention Day 3, but always before 3-month intervention), and 3-months post-intervention (10 to 24 weeks post-intervention Day 1)

Secondary Outcomes (1)

  • OSHH Program Effectiveness of Educating Students at Immediate-post and 3-months Post the Intervention Using ASK-AD 7

    Immediately before intervention began (On Day 1 of programming), Immediately post intervention (Day 3 of programming), 3-months post intervention (6 up to 20 weeks post Day 1 of programming)

Study Arms (2)

Control

PLACEBO COMPARATOR

School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.

Behavioral: My Plate

Intervention

EXPERIMENTAL

School population with the Old SCHOOL Hip-Hop program.

Behavioral: Old SCHOOL Hip-Hop

Interventions

A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.

Also known as: OSHH Program
Intervention
My PlateBEHAVIORAL

The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA's My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.

Also known as: My Plate nutrition program
Control

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th and 5th-grade children (ages 9-11y) and their parents (age \> 20 years).
  • Selected New York City public schools with similar socio-demographic composition.

You may not qualify if:

  • Schools have already received pilot OSHH and the U.S. Department of Health and Human Services (HHS) programming.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. James M. Noble
Organization
Columbia University

Study Officials

  • James Noble, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology in the Taub Institute and the Sergievsky Center, Department of Neurology - Aging & Dementia

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 15, 2017

Study Start

September 18, 2018

Primary Completion

July 14, 2023

Study Completion

August 31, 2023

Last Updated

October 23, 2025

Results First Posted

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations