Food DeprivationNCT06579079
Improving Participation in Universal School Meals (USM)
A study testing Implementation Mapping and Waitlist Comparison - Implementation Mapping in people with Food Deprivation and Obesity, Childhood, run by Temple University at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM). Read more about this study
- Who is it for?
- Ages 11 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Deprivation, Obesity, Childhood
- What is being tested?
- Implementation Mapping and Waitlist Comparison - Implementation Mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 31 Jan 2028
- 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 11 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- An elementary/middle or high school within the School District of Philadelphia (SDP) that provides free breakfast and lunch to students
- School is willing to be randomized to either a treatment or waitlist comparison condition
- School has a team of teachers, administration, and food service staff who are willing to complete interviews and surveys for data collection
- School has valid data for student Body Mass Index, meal participation, and food insecurity (parent reported).
- Students currently enrolled in a SDP elementary/middle/high school
- Students willing to participate in an interview and complete surveys
- Students have participated in school meals in the last year.
Who cannot join
- Charter schools and private schools
- Students not enrolled in school full time; students under 11 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Hybrid Type III Implementation-effectiveness Trial to Improve Implementation and Participation of Universal School Meals (USM)
The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).
Read the detailed description
The purpose of this cluster randomized trial is to test the effectiveness of an implementation strategy on implementation and student health outcomes of universal school meals (USM). This will be completed by developing and tailoring of an implementation strategy and testing its effectiveness though a cluster randomized design. Primary implementation outcomes of this trial are acceptability, cost, feasibility, penetration, and sustainability. Secondary student health outcomes are changes in diet quality (district-wide survey for students), food insecurity (USDA 6-item screener), and weight status. Exploratory descriptive models will be run to assess differences between intervention and control schools. To provide evidence for approaches in adolescents at highest risk for poor dietary intake, food security, and obesity risk, racial and ethnic minority adolescents from the School District of Philadelphia will comprise the majority of the sample. The principal investigator has just completed a year-long needs assessment with 8 schools across the district. We will aim to recruit 4 schools to be randomized to 1 of 2 conditions. Recruitment is underway, final recruitment details will be added once randomization is complete. From these schools, we aim to randomize (2 intervention; 2 waitlist comparison) for the development and tailoring of an implementation strategy. At baseline and throughout the 2-year trial period, we aim to collect interview data and surveys, and analyze data on diet quality, food security, and weight status.
- Conditions
- Food Deprivation, Obesity, Childhood
- Being tested
- Implementation Mapping, Waitlist Comparison - Implementation Mapping
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation MappingOther
Implementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy.
Waitlist Comparison - Implementation MappingOther
Implementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy. Participating schools receiving this treatment will wait one year before developing an implementation strategy for testing.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Strategy - Intervention Condition | Experimental | Schools in the intervention condition will be assigned to receive coaching and logistical support to develop and tailor an implementation strategy across 1 academic year. This strategy will then be implemented gradually and in the following academic years (2- year pilot). Receives: Other: Implementation Mapping |
| Waitlist Control | Active comparator | Schools in the waitlist control will wait 1 academic year before developing and testing an implementation strategy (1-year pilot) Receives: Other: Waitlist Comparison - Implementation Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
School Meal Participation
Counts to calculate number of students who participate in breakfast and lunch each day will be generated and totaled for each school.
Measured: Throughout study completion
Qualitative Interviews
Focus group interviews with students, parents, teachers, administration, and food service staff.
Measured: 1 year
Implementation Mapping Self-Assessment
Self-assessment to document fidelity to implementation mapping procedures.
Measured: 1 year
Implementation Cost Measure
A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.
Measured: 1 Year
Implementation Outcomes Surveys
Implementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders
Measured: 1 Year
Secondary outcomes (4)
Height
Student height (feet, inches) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.
Measured: Baseline and 1 year
Food Insecurity
The United States Department of Agriculture (USDA) 6-item food screening questionnaire is administered to parents across the district. These data are a secondary outcome to implementation outcomes.
Measured: Baseline and 1 year
Dietary Behaviors
Students complete a survey each year which records their nutrition behaviors such as fruit and vegetable consumption, sugar-sweetened beverages, and other key behaviors. These data are a secondary outcome to implementation outcomes.
Measured: Baseline and 1 year
Student Weight
Student weight (pounds) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start20 Feb 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food DeprivationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- The School District of Philadelphia, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Gabriella McLoughlin, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579079
- Sponsor's protocol ID
- #28959
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data elements: 1) Individual linked integrated database containing up to \~1000 records from the School District of Philadelphia from 2024-2027; 2) up to \~100 interview recordings and transcripts conducted with students in middle (6-8) and high (9-12) school grades, teachers, food service staff/personnel, administrators, and other staff; 3) up to \~30-50 survey entries to capture implementation outcomes of acceptability, feasibility, cost, and sustainability. 1\) Data are accessible only to the study team through an existing data license agreement between Temple University and the School District of Philadelphia. We do not anticipate the ability to preserve and share these data. 2) Transcripts will be de-identified and any potentially revealing information will be removed prior to sharing. 3) Survey data will be de-identified and any potentially revealing information will be removed prior to sharing.
Publications
Smith A, Kulkarni D, Dubrin-Meneses S, Jones RM, Deutsch J, Kurtz J, Hong I, Kane H, Virudachalam S, Kumanyika S, Brownson R, McLoughlin GM. Increasing the Potential Effectiveness of Universal School Meals through Community- Engaged Implementation Mapping: A Qualitative Case Study. Res Sq [Preprint]. 2026 Apr 19:rs.3.rs-8902980. doi: 10.21203/rs.3.rs-8902980/v1.
PubMed 42040938McLoughlin GM, Smith A, Dopp AR, Jones R, Martinez O, Kumanyika S, Yucel R, Brownson RC, Fisher JO. Using implementation mapping to optimize the impact of Universal School meals: a type III hybrid implementation-effectiveness study protocol. Implement Sci Commun. 2025 Oct 1;6(1):97. doi: 10.1186/s43058-025-00769-y.
PubMed 41034951
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Type III Implementation-effectiveness Trial to Improve Implementation and Participation of Universal School Meals (USM)
- ClinicalTrials.gov ID
- NCT06579079
- Acronym / sponsor ID
- #28959
- Conditions
- Food Deprivation, Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- The School District of Philadelphia, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 30 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 purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).
Detailed description
The purpose of this cluster randomized trial is to test the effectiveness of an implementation strategy on implementation and student health outcomes of universal school meals (USM). This will be completed by developing and tailoring of an implementation strategy and testing its effectiveness though a cluster randomized design. Primary implementation outcomes of this trial are acceptability, cost, feasibility, penetration, and sustainability. Secondary student health outcomes are changes in diet quality (district-wide survey for students), food insecurity (USDA 6-item screener), and weight status. Exploratory descriptive models will be run to assess differences between intervention and control schools. To provide evidence for approaches in adolescents at highest risk for poor dietary intake, food security, and obesity risk, racial and ethnic minority adolescents from the School District of Philadelphia will comprise the majority of the sample. The principal investigator has just completed a year-long needs assessment with 8 schools across the district. We will aim to recruit 4 schools to be randomized to 1 of 2 conditions. Recruitment is underway, final recruitment details will be added once randomization is complete. From these schools, we aim to randomize (2 intervention; 2 waitlist comparison) for the development and tailoring of an implementation strategy. At baseline and throughout the 2-year trial period, we aim to collect interview data and surveys, and analyze data on diet quality, food security, and weight status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation Strategy - Intervention Condition | Experimental | Other: Implementation MappingSchools in the intervention condition will be assigned to receive coaching and logistical support to develop and tailor an implementation strategy across 1 academic year. This strategy will then be implemented gradually and in the following academic years (2- year pilot). |
| Waitlist Control | Active comparator | Other: Waitlist Comparison - Implementation MappingSchools in the waitlist control will wait 1 academic year before developing and testing an implementation strategy (1-year pilot) |
Who may qualify
- Ages
- 11 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- An elementary/middle or high school within the School District of Philadelphia (SDP) that provides free breakfast and lunch to students
- School is willing to be randomized to either a treatment or waitlist comparison condition
- School has a team of teachers, administration, and food service staff who are willing to complete interviews and surveys for data collection
- School has valid data for student Body Mass Index, meal participation, and food insecurity (parent reported).
- Students currently enrolled in a SDP elementary/middle/high school
Key exclusion criteria (2 listed)
- Charter schools and private schools
- Students not enrolled in school full time; students under 11 years of age.
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 |
|---|---|---|
| Implementation MappingImplementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy. | Other | Implementation Strategy - Intervention Condition |
| Waitlist Comparison - Implementation MappingImplementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy. Participating schools receiving this treatment will wait one year before developing an implementation strategy for testing. | Other | Waitlist Control |
Primary outcome
School Meal Participation
Time frame: Throughout study completion
Counts to calculate number of students who participate in breakfast and lunch each day will be generated and totaled for each school.
Qualitative Interviews
Time frame: 1 year
Focus group interviews with students, parents, teachers, administration, and food service staff.
Implementation Mapping Self-Assessment
Time frame: 1 year
Self-assessment to document fidelity to implementation mapping procedures.
Implementation Cost Measure
Time frame: 1 Year
A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.
Implementation Outcomes Surveys
Time frame: 1 Year
Implementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders
4 secondary outcomes
Height
Time frame: Baseline and 1 year
Food Insecurity
Time frame: Baseline and 1 year
Dietary Behaviors
Time frame: Baseline and 1 year
Student Weight
Time frame: Baseline and 1 year
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 24 Apr 2025.
- Derived from this study: PubMed 42040938Smith A, Kulkarni D, Dubrin-Meneses S, Jones RM, Deutsch J, Kurtz J, Hong I, Kane H, Virudachalam S, Kumanyika S, Brownson R, McLoughlin GM. Increasing the Potential Effectiveness of Universal School Meals through Community- Engaged Implementation Mapping: A Qualitative Case Study. Res Sq [Preprint]. 2026 Apr 19:rs.3.rs-8902980. doi: 10.21203/rs.3.rs-8902980/v1.
- Derived from this study: PubMed 41034951McLoughlin GM, Smith A, Dopp AR, Jones R, Martinez O, Kumanyika S, Yucel R, Brownson RC, Fisher JO. Using implementation mapping to optimize the impact of Universal School meals: a type III hybrid implementation-effectiveness study protocol. Implement Sci Commun. 2025 Oct 1;6(1):97. doi: 10.1186/s43058-025-00769-y.
- Individual participant dataSharing planned: Yes. Data elements: 1) Individual linked integrated database containing up to ~1000 records from the School District of Philadelphia from 2024-2027; 2) up to ~100 interview recordings and transcripts conducted with students in middle (6-8) and high (9-12) school grades, teachers, food service staff/personnel, administrators, and other staff; 3) up to ~30-50 survey entries to capture implementation outcomes of acceptability, feasibility, cost, and sustainability. 1) Data are accessible only to the study team through an existing data license agreement between Temple University and the School District of Philadelphia. We do not anticipate the ability to preserve and share these data. 2) Transcripts will be de-identified and any potentially revealing information will be removed prior to sharing. 3) Survey data will be de-identified and any potentially revealing information will be removed prior to sharing.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Mapping and Waitlist Comparison - Implementation Mapping in people with Food Deprivation and Obesity, Childhood, run by Temple 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 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Meal Participation (time frame: Throughout study completion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579079, which also lists 2 linked publications.
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 24 Apr 2025.