Eatwell Clinical Trial (R01)

NCT07225881 | Recruiting DMC

• 1 other identifier: R01CA288323
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer is a leading cause of death and will affect many people in their lifetimes. Organizations such as the American Cancer Society and the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) have noted that dietary quality is a key factor influencing cancer risk, but most Americans do not meet these dietary guidelines for cancer prevention. The proposed study will enroll adults from the community (n=236 index participants, 236 household members; N = 472) who have low adherence to WCRF/AICR's four dietary guidelines. Participants will be randomized to either nutrition education or the Eatwell intervention. The Eatwell intervention content is focused on helping participants make healthier grocery shopping decisions, eat at home more often to take advantage of the optimal defaults present there, and learn how to navigate temptation when eating away from home. The findings will be relevant not only to the field of cancer prevention, but to the prevention of other diseases for which dietary quality is important.

Conditions

Cancer Prevention; Dietary Guidelines

Outcome Measures

Primary Outcomes (1)

• Total dietary adherence score

  Index participants will complete the ASA24 for 2 weekdays and 1 weekend day at each assessment point. A research assistant (blind to study condition) will complete the first food recall at baseline with each participant via videoconference. Participants complete recalls independently thereafter unless they indicate a preference for completing with a staff member. Information on dietary intake from the ASA24 will be used to calculate the total dietary adherence score, which is the primary outcome.

  0, 6, 18 months

Secondary Outcomes (3)

• Intake of targeted food groups

  0, 6, 18 months

• Inflammation

  0, 6, 18 months

• Dietary quality

  0, 6, 18 months

Other Outcomes (19)

• Participant age

  0 months

• Participant weight

  0 months

• Participant height

  0 months

Study Arms (2)

Eatwell Condition

EXPERIMENTAL

Index participant and household members receive Eatwell intervention

Behavioral: Eatwell

Comparison Condition

ACTIVE COMPARATOR

Index participants receive nutrition education sessions; household members receive no intervention contact

Other: Nutrition Education Control Group

Interventions

Eatwell BEHAVIORAL

The Eatwell intervention content is focused on helping participants make healthier grocery shopping decisions, eat at home more often to take advantage of the optimal defaults present there, and learn how to navigate temptation when eating away from home. The intervention itself involves nutrition education, self-regulation, motivation, and household support. In total, it will last 18 months; index participants will attend 12 workshop sessions that are 90 minutes each. Each workshop session will include approximately 12-16 index participants. The first four sessions will be held weekly in Month 1, and subsequent sessions decrease in frequency. Each index participant will have one enrolled household member who will be asked to join four workshop sessions in a support role: sessions 3, 4, 7, and 10. In these four sessions, household members will receive education about WCRF/AIRC recommendations and training in how to provide instrumental and emotional support to index participants.

Eatwell Condition

Nutrition Education Control Group OTHER

In the control condition, index participants will receive nutrition education in a series of 12 workshop sessions, following the same schedule as participants in the Eatwell condition. All of the content described under the "nutrition education" component of the Eatwell intervention will be provided. The educational material will be delivered with greater detail and with additional in-session activities, as greater time is devoted to education in the control vs. experimental condition. Participants also will receive monthly educational email messages reiterating key ideas from workshops. Specialized content and activities related to self-regulation and motivation will not be provided in the control condition. If an index participant is randomized to the control condition, their designated household member will have no intervention involvement and will only complete assessments.

Comparison Condition

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Access to technology necessary to receive emails and join videoconferencing meetings
• Ability to read and speak English
• Willingness to be randomized to either study condition, including ability and willingness to attend intervention sessions
• Ability and willingness to attend intervention sessions, receive monthly email messages, and serve in support role if index participant in household is assigned to Eatwell condition
• Able and willing to visit a commercial laboratory partnered with this project (e.g., Labcorp) in order to have their blood drawn at the time of study visits
• Low adherence to WCRF/AICR's four dietary guidelines (operationalized as a level of intake, based on brief self-report questions administered during phone screening, that corresponds to a score of 2 or less in the Shams-White method of dietary adherence scoring)
• Share a household (i.e., a private residence with a shared living space, including kitchen) with an adult who provides informed consent, meets eligibility criteria, and anticipates remaining in this household for the majority of the next 18 months
• Agree that they will not join another intervention study run by this study team in the next 18 months
• Successful completion by self and household member of all enrollment and baseline data collection tasks
• Have an email that they regularly check and willingness to use that for corresponding to study staff
• Weight at baseline of 396 lbs or less, as the digital scales used for measurement are not able to obtain measurements for weights higher than this

You may not qualify if:

• A medical or psychiatric condition, including self-reported history of anorexia nervosa or bulimia nervosa, that may limit appropriateness of or ability to comply with dietary recommendations
• A psychiatric condition, including self-reported history of anorexia nervosa or bulimia nervosa, that may make it difficult or inappropriate for household member to serve in support role
• Currently taking medication that can substantively change appetite or eating behavior, including using of a GLP-1 medication
• Planning to enroll in another lifestyle modification program in the next 18 months
• History of bariatric surgery
• Currently pregnant or planning to become pregnant in the next 18 months
• Type 1 Diabetes

Sponsors & Collaborators

• Drexel University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Central Study Contacts

Research Coordinator, BA

CONTACT

724-619-1461; aeu26@drexel.edu

Meghan L Butryn, PhD

CONTACT

215-553-7108; mlb34@drexel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychological and Brain Sciences

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 10, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 12 months after study completion.
• Access Criteria: Public availability

Locations

US (1)