NCT06699589

Brief Summary

These are the exploratory aims of the original trial cohort study "Old School Hip Hop RCT (AAAR5473)," which recruited 783 parents.

  1. 1.Continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study timeframe - aiming to understand participant knowledge and personal experiences with family members or friends affected by Alzheimer's Disease (AD).
  2. 2.Further examining the degree of comfort with dementia, as measured by a simplified version of the Dementia Attitudes Scale (DAS) focused on observable behaviors in children by their parents - aiming to understand the extent of stigmatization of dementia in communities served by this program, and if the trial impacted evidence of stigma.
  3. 3.Enrolling up to 75 parents who primarily spoke Spanish who were originally contacted in the RCT but were not eligible for completion of the original round of surveys given that all study materials were in English. This approach aims to better understand the impact of the program and Alzheimer disease on these families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable alzheimer-disease

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

Study Start

First participant enrolled

September 11, 2019

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

5.5 years

First QC Date

November 19, 2024

Last Update Submit

June 24, 2025

Conditions

Keywords

dementiaschoolsnutritionhealth education

Outcome Measures

Primary Outcomes (2)

  • Delayed Dementia Symptom and Response Knowledge Assessment Score

    An instrument with multiple choice questions to assess knowledge of recognition of key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia. Parents were asked knowledge questions at three timepoints in main trial. This additional fourth time point would capture any changes in delayed knowledge retention (starting at 15-Months post baseline data collection).

    From 15 to 48 months post baseline data collection

  • Spanish Dementia Symptom and Response Knowledge Assessment Score (Spanish Speaking Parents)

    Spanish Translated instrument with multiple choice questions to assess knowledge of recognition of key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia.

    From 2.5 to 6 years post student baseline collection

Secondary Outcomes (3)

  • Spanish Parent Semi-Structured Interview

    From 2.5 to 6 years post student baseline collection

  • Adapted Dementia Attitude Scale for Children & Parents

    From 15 to 48 months post baseline data collection

  • Spanish Adapted Dementia Attitude Scale for Children & Parents (Spanish Speaking Parents)

    From 2.5 to 6 years post student baseline collection

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Behavioral: My Plate (Nutrition Education)

Intervention

EXPERIMENTAL

School population with the Old SCHOOL Hip-Hop program.

Behavioral: Old SCHOOL Hip-Hop (Dementia Education)

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.

Intervention

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent that participated in the OSHH Trial
  • Parent that expressed interest in participating, but originally excluded from OSHH Trial due to language barrier

You may not qualify if:

  • Did not have a participating child in OSHH Trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaHealth Education

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • James M Noble, MD

    Associate Professor, Taub Institute, Columbia University

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 21, 2024

Study Start

September 11, 2019

Primary Completion

March 4, 2025

Study Completion

March 4, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations