NCT07167004

Brief Summary

Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Oct 2025Feb 2027

First Submitted

Initial submission to the registry

July 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

July 25, 2025

Last Update Submit

May 15, 2026

Conditions

Keywords

chronic diseasediabetesdiabetes mellitustype II diabetestype 2 diabetespre-diabetesprediabeteswhole grainsbehavioral economicsmarketing nudgesfinancial incentivesfood is medicine

Outcome Measures

Primary Outcomes (1)

  • Change in calories purchased from products that are majority whole grains over time

    The study team will use random-effects linear regression models to compare within-subject changes in the calories purchased from whole grains, adjusting for repeated measures, to examine trends over time.

    18 weeks

Secondary Outcomes (16)

  • Change in calories purchased from products that are majority refined grains over time

    18 weeks

  • Percent of cart spent on whole grains (total dollar on whole grains/cart total)

    18 weeks

  • Change in dollars spent on products that are majority whole grains over time

    18 weeks

  • Assessing whole and refined grain purchasing frequency

    Assessed at baseline and in end-of-study survey (Week 18)

  • Percentage of time grains were purchased as whole and refined grains

    Assessed at baseline and in end-of-study survey (Week 18)

  • +11 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

Completion of weekly grocery shopping in a version of the study store without any interventions (i.e., without marketing nudges and financial incentives)

Marketing Nudges Only

EXPERIMENTAL

Marketing nudges encouraging whole grain purchasing, including displaying whole grains (e.g., whole wheat bread, brown rice) at the top of the study's online grocery store, featuring whole grain banner displays, and offering product swaps to highlight whole grain alternatives

Behavioral: Marketing Nudges Only

Marketing Nudges + Dynamically Adapted Financial Incentives

EXPERIMENTAL

Marketing nudges encouraging whole grain purchasing, including displaying whole grains (e.g., whole wheat bread, brown rice) at the top of the study's online grocery store, featuring whole grain banner displays, and offering product swaps to highlight whole grain alternatives, plus personalized financial incentives with individual incentive amounts optimized weekly based on prior whole grain purchasing behavior and engagement

Behavioral: Marketing Nudges + Dynamically Adapted Financial Incentives

Interventions

Marketing nudges encouraging whole grain purchasing, including displaying whole grains (e.g., whole wheat bread, brown rice) at the top of the study's online grocery store, featuring whole grain banner displays, and offering product swaps to highlight whole grain alternatives

Marketing Nudges Only

Marketing nudges encouraging whole grain purchasing, including displaying whole grains (e.g., whole wheat bread, brown rice) at the top of the study's online grocery store, featuring whole grain banner displays, and offering product swaps to highlight whole grain alternatives, plus personalized financial incentives with individual incentive amounts optimized weekly based on prior whole grain purchasing behavior and engagement

Marketing Nudges + Dynamically Adapted Financial Incentives

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45 - 70 years.
  • Able to provide consent.
  • Resident of Philadelphia, Bucks, Delaware, Chester, or Montgomery Counties in Pennsylvania.
  • Consume \<5 servings of whole grains per week.
  • Use online grocery shopping at least once per month.
  • Have access to a credit or debit card to pay for groceries purchased.
  • Have reliable internet access.
  • Speak English.
  • Penn Medicine patient diagnosed with prediabetes or diabetes (identified using ICD-10 codes R73.03, E11).

You may not qualify if:

  • Not able to speak English.
  • Not able to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose IntoleranceChronic DiseaseDiabetes MellitusPrediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sophia V Hua, PhD, MPH

    Department of Medical Ethics and Health Policy, Perelman School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will be informed that they will be randomly assigned to one of the three intervention arms, but they will not be told which group they are in. It will be necessary to omit these details so that participants will shop for their groceries as they would do in the real-world. The study team hopes this approach minimizes the chances that the participant will purchase foods that they think the study team wants them to purchase. Participants will be fully informed about the randomization process. To conceal the study's purpose, participants will be told that the study team is conducting consumer market research about online shopping experiences but will not be told the study team is specifically interested in understanding the effects of marketing and incentives on whole grain purchases. Participants will be fully debriefed at the end of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2025

First Posted

September 11, 2025

Study Start

October 14, 2025

Primary Completion (Estimated)

February 16, 2027

Study Completion (Estimated)

February 16, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

All data will be de-identified. De-identified IPD that underlie results in a publication can be requested by other researchers. The PI will review any and all requests to access the de-identified study data. SecureShare or PennBox, both secure methods to transfer files, will be used to transfer data.

Time Frame
One year after publication of the main trial results.
Access Criteria
The PI will review any and all requests to access the de-identified study data.

Locations