Eatwell nutrition program to improve diets linked to cancer prevention
Efficacy of a Multi-level Intervention Designed to Promote Adherence to WCRF/AICR Dietary Guidelines for Cancer Prevention
This trial will test whether the Eatwell program helps adults with low adherence to cancer-prevention dietary guidelines eat more fruits, vegetables and whole grains and cut back on processed foods, red/processed meat, and sugary drinks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 472 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Drexel University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07225881 on ClinicalTrials.gov |
What this trial studies
This randomized, two-arm trial will enroll 236 index adults plus 236 adult household members (N=472) who score low on WCRF/AICR dietary guidelines and randomize them to the Eatwell intervention or traditional nutrition education. The Eatwell program focuses on healthier grocery choices, eating at home more often, and strategies for handling temptations when eating out, delivered via sessions and monthly emails with household support. The primary outcome is a total dietary adherence score calculated using NCI's standardized scoring system, with secondary outcomes including grams/day of fruits, vegetables, and fiber; percent of calories from ultra-processed foods; grams/week of red and processed meat; grams/day of sugar-sweetened beverages; and biomarkers of inflammation measured from blood draws. Participants will need technology for videoconferencing and must be willing to provide blood samples at a partnered commercial laboratory.
Who should consider this trial
Good fit: Adults aged 18 or older who live with another adult, have low adherence to WCRF/AICR cancer-prevention dietary guidelines, can read and speak English, have the technology to join virtual sessions, are willing to be randomized and attend sessions, and can provide blood samples at a partner lab are ideal candidates.
Not a fit: People who already meet the cancer-prevention dietary guidelines, cannot attend intervention sessions or lab visits, lack the required technology, or cannot participate in household-based changes are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the Eatwell approach could help people adopt dietary patterns linked to lower cancer risk and improve inflammation-related biomarkers.
How similar studies have performed: Prior lifestyle and nutrition interventions have produced modest improvements in diet quality and some biomarkers, and the Eatwell program builds on that literature with a household-focused approach that is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Drexel University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Research Coordinator, BA
- Email: aeu26@drexel.edu
- Phone: 724-619-1461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.