Advanced Cooking Education Full Scale Study (ACE)

August 14, 2024 updated by: Cornell University

Advanced Cooking Education (ACE) 4-H After School Club Full Scale Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The ACE program is conducted with 7th and 8th grade students attending New York City (NYC) Title I middle schools. Participants attend weekly sessions (2hour) after school to participate in mindfulness, nutrition lessons, and professional development activities. On another day in the week, students participate in cooking labs at their own time at their homes. The investigators hypothesize that after the program, adolescents' diet quality, cooking-related skills, stress levels will be improved compared to prior of the program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Ithaca, New York, United States, 14853
        • Recruiting
        • Cornell University
        • Contact:
        • Principal Investigator:
          • Tashara M Leak, PhD RD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 7th 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control phase
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.
Experimental: ACE intervention
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in change in diet quality between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in change in body mass index between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Height will be measured using stadiometer to nearest decimal point in cm. Weight is measured using scale to nearest decimal in kg. Body mass index calculated using kg/m^2.
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)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Measured using a scale to nearest decimal
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in waist circumference between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Measured using a waist circumference tape to the nearest decimal in cm
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)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for increased fruits and vegetables consumption
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in culinary skills between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
iCook program youth culinary skill survey with 5-point likert scale questions with higher scores indicate higher skill level (better outcome). Min=7, Max=35
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in culinary self-efficacy between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
iCook program youth culinary self-efficacy survey with 5-point likert scale questions with higher scores indicate higher skill level (better outcome). Min=6, Max=30
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in culinary attitudes between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Cooking with kids survey with 5-point likert scale questions with higher scores indicate more positive attitude (better outcome). Min=6, Max=30
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in perceived stress between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Used the Cohen perceived stress scale. Higher scores mean increased stress (worse outcome). Min=0, Max=40
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in family mealtime beliefs between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Calculated based on the Fulkerson family mealtime survey. A total of 9 questions that are scored independently. Each: Min=1, Max=4. Higher scores indicate better family mealtime practices (better outcome).
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)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Short form food security survey module by the United States Department of Agriculture (USDA). Higher scores indicate lower food security status. Min=0, Max=6
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in food neophobia between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Food Neophobia Test Tool 10-item survey (FNTT10) with 5-point likert scale questions, higher scores mean less neophobia (better outcome). Min=10, Max=50.
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in sense of purpose between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Used the Claremont Purpose Scale survey questions, higher scores mean higher sense of purpose (better outcome). Min=12, Max=60
0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in social and emotional competency between intervention phase (12-24wk) and control phase (0wk-12wk)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Used the Social and Emotional Competency (SEC) survey by Collaborative for Academic, Social, and Emotional Learning (CASEL), higher scores mean higher competence (better outcome). Min=17, Max= 68
0 weeks, 12 weeks, 24 weeks, 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Agriculture (USDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tashara M Leak, PhD, RD, Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0148035
  • IRB0147778 (Other Identifier: Cornell University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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