- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07561593
Improving Health Outcomes Through Investigations of Wabanaki Food Systems in Maine
April 30, 2026 updated by: Wabanaki Public Health and Wellness
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults age 18 years and older
- Members of a Wabanaki community
Exclusion Criteria:
-None
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile Food Pantry Community Intervention Group
Community participants exposed to the upscaled Mobile Food Pantry Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (Wabanaki Community Survey pilot period, approximately 3-6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Quality of Life (CDC HRQoL Indicators)
Time Frame: Baseline (during Wabanaki Community Survey data collection period)
|
Health-related quality of life will be measured using the CDC HRQoL-4 indicators included in the Wabanaki Community Survey. Measures include:
Each indicator will be reported separately.
These measures will be used in analyses assessing their correlation with Mobile Food Pantry utilization. |
Baseline (during Wabanaki Community Survey data collection period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
May 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
April 10, 2026
First Submitted That Met QC Criteria
April 30, 2026
First Posted (Actual)
May 1, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OT2OD035832 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
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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