Adolescent BehaviorACENCT06558396
Advanced Cooking Education Full Scale Study
A study testing ACE intervention in people with Adolescent Behavior and Nutrition, Healthy, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Nutrition, Healthy
- What is being tested?
- ACE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do not speak/understand English
- Those who have previously participated in the Virtual ACE program (Feasibility Study), or In-Person ACE Pilot Study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cornell University
Ithaca, New York, 14853
Tashara M Leak, PhD, RD, 607-255-5967, tml226@cornell.edu
Tashara M Leak, PhD RD
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Behavior, Nutrition, Healthy
- Being tested
- ACE intervention
- Keywords
- Adolescents, Nutrition intervention, Culinary programs
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ACE intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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)
Measured using a scale to nearest decimal
Measured: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in waist circumference between intervention phase (12-24wk) and control phase (0wk-12wk)
Measured using a waist circumference tape to the nearest decimal in cm
Measured: 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)
Measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for increased fruits and vegetables consumption
Measured: 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)
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
Measured: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in culinary skills between intervention phase (12-24wk) and control phase (0wk-12wk)
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
Measured: 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)
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
Measured: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in culinary attitudes between intervention phase (12-24wk) and control phase (0wk-12wk)
Cooking with kids survey with 5-point likert scale questions with higher scores indicate more positive attitude (better outcome). Min=6, Max=30
Measured: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in perceived stress between intervention phase (12-24wk) and control phase (0wk-12wk)
Used the Cohen perceived stress scale. Higher scores mean increased stress (worse outcome). Min=0, Max=40
Measured: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Difference in change in food neophobia between intervention phase (12-24wk) and control phase (0wk-12wk)
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.
Measured: 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)
Used the Claremont Purpose Scale survey questions, higher scores mean higher sense of purpose (better outcome). Min=12, Max=60
Measured: 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)
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
Measured: 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)
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).
Measured: 0 weeks, 12 weeks, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Nov 2023
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Tashara M Leak, PhD, RD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558396
- Sponsor's protocol ID
- 0148035
- Other IDs
- IRB0147778
- Acronym
- ACE
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cooking Education (ACE) 4-H After School Club Full Scale Study
- ClinicalTrials.gov ID
- NCT06558396
- Acronym / sponsor ID
- ACE / 0148035
- Conditions
- Adolescent Behavior, Nutrition, Healthy
- Keywords
- Adolescents, Nutrition intervention, Culinary programs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: ACE interventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Do not speak/understand English
- Those who have previously participated in the Virtual ACE program (Feasibility Study), or In-Person ACE Pilot Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE interventionParticipants 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). | Behavioural | ACE intervention |
Primary outcome
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).
13 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tashara M Leak, PhD, RD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACE intervention in people with Adolescent Behavior and Nutrition, Healthy, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tashara M Leak, PhD, RD (607-255-7664, tml226@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.