NCT06558396

Brief Summary

The aim of this study is to assess the impact of an in-person multi-component Advanced Cooking Education (ACE) 4-H after school program. The ACE Program consists of mindfulness, nutrition education, cooking labs, and professional development activities.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress86%
Nov 2023Oct 2026

Study Start

First participant enrolled

November 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

2.6 years

First QC Date

August 14, 2024

Last Update Submit

August 14, 2024

Conditions

Keywords

AdolescentsNutrition interventionCulinary programs

Outcome Measures

Primary Outcomes (1)

  • Difference in change in diet quality between intervention phase (12-24wk) and control phase (0wk-12wk)

    Healthy Eating Index (HEI) scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects higher alignment between one's diet and recommendations from Dietary Guidelines for Americans (DGA).

    0 weeks, 12 weeks, 24 weeks, 48 weeks

Secondary Outcomes (13)

  • Difference in change in body mass index between intervention phase (12-24wk) and control phase (0wk-12wk)

    0 weeks, 12 weeks, 24 weeks, 48 weeks

  • Difference in change in body fat percentage between intervention phase (12-24wk) and control phase (0wk-12wk)

    0 weeks, 12 weeks, 24 weeks, 48 weeks

  • Difference in change in waist circumference between intervention phase (12-24wk) and control phase (0wk-12wk)

    0 weeks, 12 weeks, 24 weeks, 48 weeks

  • Difference in change in dermal carotenoids level between intervention phase (12-24wk) and control phase (0wk-12wk)

    0 weeks, 12 weeks, 24 weeks, 48 weeks

  • Difference in change in household food security between intervention phase (12-24wk) and control phase (0wk-12wk)

    0 weeks, 12 weeks, 24 weeks, 48 weeks

  • +8 more secondary outcomes

Study Arms (2)

Control phase

NO INTERVENTION

After the first data collection session, participants spend 12 weeks and enter a "control phase" where they receive no intervention. At the end of the 12 weeks, participants will attend another data collection session.

ACE intervention

EXPERIMENTAL

The ACE Program is a culturally inclusive, 4-H after school club where youth meet once a week for 12 weeks after school in person. They also receive groceries to make a meal 1 day every 2 weeks.

Behavioral: ACE intervention

Interventions

Participants attend the ACE Program for 12 weeks after school. On one assigned day of the week, participants attend ACE in person after school. The session begins with mindfulness exercises (20 minutes), nutrition education lesson/cooking lab (65 minutes, odd weeks) OR professional development session (65 minutes, even weeks). On any day during the 2-week cooking period, the students will make a dish using groceries they received with their parent/guardian (1 hour).

ACE intervention

Eligibility Criteria

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

You may qualify if:

  • th and 8th grade students attending Title I funded schools in New York City
  • Caregivers of the 7th and 8th grade students attending Title I funded schools in New York City

You may not qualify if:

  • Do not speak/understand English
  • Those who have previously participated in the Virtual ACE program (Feasibility Study), or In-Person ACE Pilot Study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

RECRUITING

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tashara M Leak, PhD, RD

    Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tashara M Leak, PhD, RD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants enter a control phase for 12 weeks where they receive no intervention. After 12 weeks, the same group of participants receive the ACE intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

November 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations