Food SecurityNCT07251283
Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2
A study testing NE + Meal Delivery (NE+MD) intervention in people with Food Security, run by University of Vermont at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effects of a novel, mail-based meal delivery intervention among individuals receiving MOUD on household food security status. The main question it aims to answer is: Will participants randomized to the NE+MD intervention will demonstrate greater reductions in USDA FSS scores… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Security
- What is being tested?
- NE + Meal Delivery (NE+MD) intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2025to Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- receiving methadone or buprenorphine treatment for OUD
- meet criteria for current FI as measured by the 18-item US Household Food Security Survey (FSS; Economic Research Service, USDA, 2012)
Who cannot join
- Significant psychiatric or medical illness
- Pregnant or nursing
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
University of Vermont
Burlington, Vermont, 05401
Stacey Sigmon, Ph.D., 802-656-9987, ssigmon@uvm.edu
About this study
The goal of this study is to evaluate the effects of a novel, mail-based meal delivery intervention among individuals receiving MOUD on household food security status. The main question it aims to answer is:
- Will participants randomized to the NE+MD intervention will demonstrate greater reductions in USDA FSS scores from intake to Study Week 24 than NE participants?
Read more
Participants with OUD and FI will be randomly assigned to one of two 24-week experimental conditions: Nutritional Education alone (NE) or NE + Meal Delivery (NE+MD).
NE control participants will receive brief NE, a list of FI-related resources in their community, and assistance with contacting any resources of interest.
NE+MD participants will receive the same educational platform plus commercial weekly meal deliveries directly to the participant's home (6 meals per week per household member).
All participants will complete monthly follow-up assessments throughout the 24-week study measuring food security status, psychosocial functioning, and biometric measures of health. All participants will also complete monthly follow-up assessments for 6 months post-intervention.
- Conditions
- Food Security
- Being tested
- NE + Meal Delivery (NE+MD) intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NE + Meal Delivery (NE+MD) interventionOther
NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Education (NE) control condition | No intervention | Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. |
| Nutritional Eduction + Meal Delivery (NE+MD) experimental condition | Experimental | NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home. Receives: Other: NE + Meal Delivery (NE+MD) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household food insecurity
Household food insecurity as measured by the USDA Household Food Security Survey (FSS)
Measured: Monthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start7 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SecurityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-groups pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey C. Sigmon, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251283
- Sponsor's protocol ID
- STUDY00003125
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2
- ClinicalTrials.gov ID
- NCT07251283
- Acronym / sponsor ID
- STUDY00003125
- Conditions
- Food Security
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Nov 2025 (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 goal of this study is to evaluate the effects of a novel, mail-based meal delivery intervention among individuals receiving MOUD on household food security status. The main question it aims to answer is:
- Will participants randomized to the NE+MD intervention will demonstrate greater reductions in USDA FSS scores from intake to Study Week 24 than NE participants?
Participants with OUD and FI will be randomly assigned to one of two 24-week experimental conditions: Nutritional Education alone (NE) or NE + Meal Delivery (NE+MD).
NE control participants will receive brief NE, a list of FI-related resources in their community, and assistance with contacting any resources of interest.
NE+MD participants will receive the same educational platform plus commercial weekly meal deliveries directly to the participant's home (6 meals per week per household member).
All participants will complete monthly follow-up assessments throughout the 24-week study measuring food security status, psychosocial functioning, and biometric measures of health. All participants will also complete monthly follow-up assessments for 6 months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel-groups pilot study
| Arm | Type | Receives |
|---|---|---|
| Nutritional Education (NE) control condition | No intervention | –Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. |
| Nutritional Eduction + Meal Delivery (NE+MD) experimental condition | Experimental | Other: NE + Meal Delivery (NE+MD) interventionNE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old
- receiving methadone or buprenorphine treatment for OUD
- meet criteria for current FI as measured by the 18-item US Household Food Security Survey (FSS; Economic Research Service, USDA, 2012)
Key exclusion criteria (2 listed)
- Significant psychiatric or medical illness
- Pregnant or nursing
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 |
|---|---|---|
| NE + Meal Delivery (NE+MD) interventionNE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home. | Other | Nutritional Eduction + Meal Delivery (NE+MD) experimental condition |
Primary outcome
Household food insecurity
Time frame: Monthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring period
Household food insecurity as measured by the USDA Household Food Security Survey (FSS)
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 26 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NE + Meal Delivery (NE+MD) intervention in people with Food Security, run by University of Vermont 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 3 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 26 Nov 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?
Contact Stacey Sigmon, Ph.D. (802-656-9987, ssigmon@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household food insecurity (time frame: Monthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring period). 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 26 Nov 2025.