SUPERSTARS: Supermarket Support for a Primary Care Healthy Food Prescription

NCT07021391 | Not Yet Recruiting

• 1 other identifier: GRANT13963005
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Few Americans meet dietary recommendations. Poor diet is a major contributor to increasing prevalence of diabetes and obesity, which are negatively impacting long term health, quality of life, and healthcare costs, particularly among low-income, racial and ethnic minority, and rural populations in the U.S. To help address these inequities, produce prescription programs are being implemented in many health care settings. However, key research gaps and programmatic barriers remain. In the proposed project, the investigators will use research, education, and extension to improve nutrition security in rural underserved communities and deliver science-based knowledge to consumers, allowing them to make informed, practical decisions that can improve health equity. The project goal is to implement and rigorously evaluate an innovative primary-care based healthy food prescription that is paired with incentives to use the local supermarket's established healthy food shelf-tag labeling system to increase healthy food choices at the point of purchase. The investigators will: 1) assess the program's impact on participants' food and nutrition security, 2) assess the program's impact on participants' supermarket purchases and diet, and explore the program's impact on health, and 3) use the research findings to engage health systems, nutrition educators, and communities in evidence-based strategies to improve nutrition security. The program has the potential to sustainably encourage healthy food choices where decisions matter-in the supermarket, using existing supermarket resources. Improving purchasing patterns by increasing sales of less processed and whole foods, could also positively affect industry offerings and sustainability of the agricultural system as a whole.

Conditions

Healthy Food Choice; Incentives; Low Income Population; Rural Health

Keywords

Healthy food Prescription; Primary care; food security; nutrition security; supermarket; healthy food incentive; shopping behavior

Outcome Measures

Primary Outcomes (1)

• Nutrition Security

  (Gretchen Swanson) 4-question validated nutrition security module. Scores range from 0 (lowest nutrition security) to 4 (highest nutrition security).

  At enrollment and within two weeks post intervention

Secondary Outcomes (3)

• Food Security

  At enrollment and within 2 weeks post intervention

• Weekly supermarket purchases for 16 months

  6 months pre to 6 months post intervention

• Healthy Eating Index (HEI) 2015 scores

  Within 2 weeks of enrollment and within 2 weeks post intervention

Study Arms (2)

Usual care

NO INTERVENTION

no intervention administered

Primary Care Food Prescription intervention plus incentive

EXPERIMENTAL

Primary Care Food Prescription intervention plus monthly $40 incentive to purchase 2 and 3 starred (via Guiding Stars) groceries at the supermarket

Behavioral: Primary care healthy food prescription plus incentive

Interventions

Primary care healthy food prescription plus incentive BEHAVIORAL

Primary care healthy food prescription with $40 monthly incentive for four months to purchase 2 and 3 starred (via Guiding Stars) groceries at the supermarket

Primary Care Food Prescription intervention plus incentive

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary care patient at one of 6 study practice sites
• aged 21 or older
• using MaineCare (Medicaid) or MaineHealth Assisted Care
• use of Hannaford Supermarket for at lest half of all household grocery shopping
• member of Hannaford loyalty program for at least 6 months
• at least 2 visits to primary care site over past 2 years

You may not qualify if:

• under 21 years of age
• older than 90 years of age
• use of private insurance
• not a Hannaford Supermarket shopper
• not the primary household shopper
• if primary household shopper, not using Hannaford Supermarket for more than half of grocery purchases
• Hannford loyalty program member for less than 6 months
• less than 2 primary care visits past 2 years

Sponsors & Collaborators

• University of New England: lead
• MaineHealth: collaborator
• Harvard Medical School / Harvard Pilgrim Health Care Institute: collaborator
• Massachusetts General Hospital: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Officials

• Michele Polacsek, PhD, MHS

  University of New England

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Polacsek, PhD, MHS

CONTACT

(207) 221-4466; mpolacsek@une.edu

Anne N Thorndike, MD, MPH

CONTACT

(617) 724-6700; athorndike@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share