- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531849
Nutrition Labelling Education Program in Socioeconomically Vulnerable Areas (PEANUTS)
Impact of a Brief Front-of-pack Nutrition Labelling Education Program on Self-efficacy, Food Literacy and Purchase Intentions in Socioeconomically Vulnerable Areas
Study Overview
Status
Intervention / Treatment
Detailed Description
Front-of-pack nutrition labels (FoPLs) have been adopted in many countries to help consumers rapidly assess the nutritional quality of foods and to encourage healthier choices. Among these schemes, interpretive systems such as Nutri-Score appear particularly promising, as their graphic design improves understanding and use compared with more complex or purely numerical formats. In France, where social inequalities in diet-related chronic diseases are pronounced, implementing and effectively using FoPLs is especially challenging in socioeconomically vulnerable areas. Seine-Saint-Denis, a department with a markedly higher prevalence of diabetes and cardiovascular diseases than the national average, offers a relevant setting to test prevention strategies embedded within routine care.
The PEANUTS project is a quasi-experimental before-after interventional study conducted first in primary care and hospital outpatient settings, with subsequent extension to social and community-based structures. The study targets adult patients living in vulnerable territories who attend municipal primary care centres or hospital services. After informed consent, participants complete a baseline questionnaire assessing food literacy, understanding and use of on-pack nutrition information (including Nutri-Score), perceived self-efficacy in choosing healthier food products in the supermarket, and the nutritional quality of purchase intentions.
The intervention consists of a brief (45-60 minute) group-based education session focused on on-pack nutrition information (Nutri-Score, nutritional declaration, nutrition and health claims, and key marketing elements). Sessions are modular and literacy-sensitive: based on the inclusion questionnaire, participants are allocated to educational pathways (Group A and/or Group B) according to their initial knowledge and food literacy profile, with two levels of intensity in each pathway (A1/A2 and B1/B2). At the beginning of each session, facilitators perform a short educational assessment to select the most appropriate level for the group and adapt examples and activities to participants' literacy levels and everyday food purchasing context. All sessions include an active discussion phase followed by a practical "learning by doing" component, using real or mock food packages and price scenarios to support the use of Nutri-Score and other FoPL elements in constrained-budget situations.
In Phase 1, the program is implemented in a university hospital group and municipal health centres in Seine-Saint-Denis. Interventions are delivered by advanced practice nurses and dietitians trained in the study protocol. Approximately 100 participants will be included in this phase, allowing an initial evaluation of feasibility, acceptability and preliminary effectiveness, as well as the collection of qualitative feedback (e.g. spontaneously raised questions, strategies to handle group heterogeneity) to inform training materials for non-specialist facilitators. In Phase 2, the program is transferred to social services and community-based organizations, where social workers and volunteers trained in PEANUTS will deliver the same modular intervention, thereby supporting capacity-building in the social sector.
Outcomes are measured at inclusion, immediately before the intervention (T0), immediately after the session (T1) and at 1-month follow-up (T2). Primary outcomes include self-efficacy in choosing healthier food products in the supermarket and a multidimensional food literacy score (label reading and food selection, meal planning and budgeting, food safety/preparation/cooking). Secondary outcomes include changes in the nutritional quality of food purchase intentions and participants' understanding and perceived usefulness of on-pack nutrition information. By integrating a brief, tailored education program into routine care pathways and later into social and community settings, the PEANUTS study aims to provide transferable tools to reduce nutrition-related health inequalities in vulnerable territories.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chantal Julia, MD, PhD
- Phone Number: +33148388932
- Email: c.julia@eren.smbh.univ-paris13.fr
Study Locations
-
-
-
Bobigny, France, 93000
- Recruiting
- Université Sorbonne Paris Nord
-
Contact:
- Chantal Julia, MD, PhD
- Phone Number: +33149388932
- Email: c.julia@eren.smbh.univ-paris13.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Respondents must be aged 18
- No formal income criterion is applied; Participants are considered as low-income (justified by the fact that the study is conducted in an area known to be socioeconomically vulnerable).
Exclusion Criteria:
- Subjects who are homeless
- Subjects who depend exclusively on food aid (Subjects never engaging in grocery shopping)
- Subjects living outside of mainland France
- French language comprehension will be assessed at baseline using functional health literacy questions in the inclusion questionnaire. Insufficient French literacy will not be used as an exclusion criterion at enrolment. Nevertheless, if analyses show that participants who do not speak and read French have outcome scores that are substantially and systematically lower than those of the rest of the sample, these participants may be excluded from planned sensitivity analyses to preserve data quality and comparability.
Study Plan
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: Intervention
The educational intervention consists of modular group sessions lasting 45-60 minutes, adapted to participants' initial profiles based on an inclusion questionnaire assessing food literacy and nutrition knowledge.
After completion of this baseline assessment, participants are allocated to educational pathways (Group A and/or Group B) according to their initial knowledge profile, with distinct objectives for each pathway.
|
At the beginning of each session, facilitators perform a brief educational assessment to select the most appropriate level for the group, allowing flexible adaptation of content to heterogeneous literacy levels.
Sessions systematically include two components: (1) an active discussion phase to convey key information, followed by (2) a practical "learning by doing" phase designed to foster autonomy in using nutrition labelling tools.
Phase 1 (≈12 months) will take place in municipal primary care centers in Seine-Saint-Denis, and delivered by advanced practice nurses and dietitians (≥10 expected).
During this phase, qualitative feedback (e.g.
spontaneously raised questions, strategies used to manage group heterogeneity) will be collected to inform the training of non-expert facilitators.
Phase 2 will extend implementation to social services and community-based organizations, where trained social workers and volunteers will deliver the same modular program, supporting capacity-building in
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy in choosing food products in the supermarket
Time Frame: Pre-intervention, immediately post-intervention, and 1-month follow-up
|
Measured through a series of 6 items rated on a 5 point Likert scale.
The final score will range from 6 to 30 points.
Higher scores mean higher self-efficacy
|
Pre-intervention, immediately post-intervention, and 1-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional quality of purchase intentions
Time Frame: Pre-intervention, immediately post-intervention, and 1-month follow-up
|
Respondents will select one food product from 8 options within each of the two choice set, scored from 1 (lower nutritional quality product - Nutri-Score E) to 5 (higher nutritional quality - Nutri-Score A).
|
Pre-intervention, immediately post-intervention, and 1-month follow-up
|
|
Food literacy
Time Frame: Pre-intervention, immediately post-intervention, and 1-month follow-up
|
Food literacy score (three subscales).
|
Pre-intervention, immediately post-intervention, and 1-month follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- USPN 2025-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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