Food InsecurityNCT07561593
Improving Health Outcomes Through Investigations of Wabanaki Food Systems in Maine
A study testing Upscaling the Wabanaki Mobile Food Pantry Program in people with Food Insecurity, run by Wabanaki Public Health and Wellness at 1 site in United States.
Trial summary
Wabanaki ancestral lands historically provided abundant resources, allowing Wabanaki people to rely exclusively on hunting, fishing, and gathering for all their subsistence needs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Upscaling the Wabanaki Mobile Food Pantry Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 years and older
- Members of a Wabanaki community
Who cannot join
- -None
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
Wabanaki Public Health and Wellness
Bangor, Maine, 04401
Nameera Fatima, MS IST, 844-844-2622, nfatima@wabanakiphw.org
Leigh Neptune, PhD, RDN
About this study
Wabanaki ancestral lands historically provided abundant resources, allowing Wabanaki people to rely exclusively on hunting, fishing, and gathering for all their subsistence needs. However, as their sacred hunting and fishing grounds were lost to colonization, the Wabanaki people lost access to their traditional foods, which has had devastating impacts on the communities' health and well-being. Without access to traditional foods like fiddleheads, corn, beans, squash, wild rice, fish, and many others, the Wabanaki people experienced a surge in many nutrition-related health problems, such as diabetes, obesity, and heart-disease, which have only increased exponentially with time. This Community Research Project (CRP) seeks to improve these health outcomes for Wabanaki people by upscaling the Wabanaki Mobile Food Pantry (WMFP), an existing program that delivers fresh and traditional foods to the Tribal communities. The CRP is grounded in the understanding that food sovereignty is fundamental to achieving and sustaining the health and well-being of Wabanaki communities. The upscaled WMFP aims to increase community access to fresh, traditional, or locally sourced foods, improve community perceptions of food pantries, support cultural connection, promote sustainable, culturally relevant food systems, and increase Tribal members' knowledge and self-efficacy surrounding the cultivation, preparation, and preservation of traditional foods.
- Conditions
- Food Insecurity
- Being tested
- Upscaling the Wabanaki Mobile Food Pantry Program
- Keywords
- community-led research, food insecurity, social determinants of health, health disparities, nutrition access, food sovereignty, community survey, photovoice, indigenous research, tribal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upscaling the Wabanaki Mobile Food Pantry ProgramBehavioural
Community-led expansion of a Mobile Food Pantry program designed to improve access to nutritious and culturally appropriate foods and address food insecurity among Wabanaki communities. Outcomes are evaluated using a pre-post study design.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Food Pantry Community Intervention Group | Experimental | Community participants exposed to the upscaled Mobile Food Pantry Intervention Receives: Behavioral: Upscaling the Wabanaki Mobile Food Pantry Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Security Status (Hunger Vital Sign / 6-Item HFSSM Score)
Food security will be measured using the validated 6-Item USDA Household Food Security Survey Module (HFSSM) included in the Wabanaki Community Survey. The outcome will report food security status categorized according to standard scoring criteria (e.g., high, marginal, low, very low food security) Unit of Measure: Food security category (per HFSSM scoring) This outcome will be used in subsequent analyses examining its correlation with Mobile Food Pantry utilization.
Measured: Baseline (Wabanaki Community Survey pilot period, approximately 3-6 months)
Secondary outcomes (1)
Health-Related Quality of Life (CDC HRQoL Indicators)
Health-related quality of life will be measured using the CDC HRQoL-4 indicators included in the Wabanaki Community Survey. Measures include:
- Number of physically unhealthy days (past 30 days)
- Number of mentally unhealthy days (past 30 days)
- Self-rated general health (5-point scale)
Each indicator will be reported separately.
- Unit of Measure:
- Days (physically unhealthy days, mentally unhealthy days)
- Units on a 5-point scale (self-rated health)
These measures will be used in analyses assessing their correlation with Mobile Food Pantry utilization.
Measured: Baseline (during Wabanaki Community Survey data collection period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start11 May 2026
- Primary completionAug 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wabanaki Public Health and Wellness
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Washington State University, Drexel University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561593
- Sponsor's protocol ID
- OT2OD035832
- Other IDs
- OT2OD035832
- Status last verified
- May 2026
- First submitted
- 10 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to Tribal data sovereignty considerations (including Ownership, Control, Access and Possession (OCAP) Principals) and community data governance agreements. Data are owned and governed by Wabanaki Tribal partners and Wabanaki Public Health and Wellness. Any data sharing will follow Tribal approval processes and established data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes Through Investigations of Wabanaki Food Systems in Maine
- ClinicalTrials.gov ID
- NCT07561593
- Acronym / sponsor ID
- OT2OD035832
- Conditions
- Food Insecurity
- Keywords
- community-led research, food insecurity, social determinants of health, health disparities, nutrition access, food sovereignty, community survey, photovoice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wabanaki Public Health and WellnessUniversity, hospital or other
- Collaborators
- Yale University, Washington State University, Drexel University
- Study start
- 11 May 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 May 2026 (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.
Wabanaki ancestral lands historically provided abundant resources, allowing Wabanaki people to rely exclusively on hunting, fishing, and gathering for all their subsistence needs. However, as their sacred hunting and fishing grounds were lost to colonization, the Wabanaki people lost access to their traditional foods, which has had devastating impacts on the communities' health and well-being. Without access to traditional foods like fiddleheads, corn, beans, squash, wild rice, fish, and many others, the Wabanaki people experienced a surge in many nutrition-related health problems, such as diabetes, obesity, and heart-disease, which have only increased exponentially with time. This Community Research Project (CRP) seeks to improve these health outcomes for Wabanaki people by upscaling the Wabanaki Mobile Food Pantry (WMFP), an existing program that delivers fresh and traditional foods to the Tribal communities. The CRP is grounded in the understanding that food sovereignty is fundamental to achieving and sustaining the health and well-being of Wabanaki communities. The upscaled WMFP aims to increase community access to fresh, traditional, or locally sourced foods, improve community perceptions of food pantries, support cultural connection, promote sustainable, culturally relevant food systems, and increase Tribal members' knowledge and self-efficacy surrounding the cultivation, preparation, and preservation of traditional foods.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Food Pantry Community Intervention Group | Experimental | Behavioral: Upscaling the Wabanaki Mobile Food Pantry ProgramCommunity participants exposed to the upscaled Mobile Food Pantry Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age 18 years and older
- Members of a Wabanaki community
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| Upscaling the Wabanaki Mobile Food Pantry ProgramCommunity-led expansion of a Mobile Food Pantry program designed to improve access to nutritious and culturally appropriate foods and address food insecurity among Wabanaki communities. Outcomes are evaluated using a pre-post study design. | Behavioural | Mobile Food Pantry Community Intervention Group |
Primary outcome
Food Security Status (Hunger Vital Sign / 6-Item HFSSM Score)
Time frame: Baseline (Wabanaki Community Survey pilot period, approximately 3-6 months)
Food security will be measured using the validated 6-Item USDA Household Food Security Survey Module (HFSSM) included in the Wabanaki Community Survey. The outcome will report food security status categorized according to standard scoring criteria (e.g., high, marginal, low, very low food security) Unit of Measure: Food security category (per HFSSM scoring) This outcome will be used in subsequent analyses examining its correlation with Mobile Food Pantry utilization.
1 secondary outcome
Health-Related Quality of Life (CDC HRQoL Indicators)
Time frame: Baseline (during Wabanaki Community Survey data collection period)
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 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to Tribal data sovereignty considerations (including Ownership, Control, Access and Possession (OCAP) Principals) and community data governance agreements. Data are owned and governed by Wabanaki Tribal partners and Wabanaki Public Health and Wellness. Any data sharing will follow Tribal approval processes and established data use agreements.
Related trials for Food Insecurity
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruitingObservational study
Addressing Food Insecurity in Pregnancy
Food Insecurity, Pregnancy
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
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 Upscaling the Wabanaki Mobile Food Pantry Program in people with Food Insecurity, run by Wabanaki Public Health and Wellness 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 1 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 May 2026. 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 Nameera Fatima, MS IST (844-844-2622, nfatima@wabanakiphw.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Security Status (Hunger Vital Sign / 6-Item HFSSM Score) (time frame: Baseline (Wabanaki Community Survey pilot period, approximately 3-6 months)). 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 May 2026.