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RECRUITING

NCT07225881

Eatwell Clinical Trial (R01)

Sponsor: Drexel University

View on ClinicalTrials.gov

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.

Official title: Efficacy of a Multi-level Intervention Designed to Promote Adherence to WCRF/AICR Dietary Guidelines for Cancer Prevention

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

472

Start Date

2026-02-10

Completion Date

2030-04-30

Last Updated

2026-03-16

Healthy Volunteers

Yes

Conditions

Cancer Prevention Dietary Guidelines

Interventions

BEHAVIORAL

Eatwell

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.

OTHER

Nutrition Education Control Group

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Drexel University

Philadelphia, Pennsylvania, United States