Cancer PreventionNCT07225881
Eatwell Clinical Trial (R01)
A study testing Eatwell in people with Cancer Prevention and Dietary Guidelines, run by Drexel University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention, Dietary Guidelines
- What is being tested?
- Eatwell
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Anna Upman, BA, 724-619-1461, aeu26@drexel.edu
Meghan L Butryn, PhD
About this study
Official title: Efficacy of a Multi-level Intervention Designed to Promote Adherence to WCRF/AICR Dietary Guidelines for Cancer Prevention
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.
Read the detailed description
The purpose of this study is to test an intervention that is designed to facilitate adherence to the dietary guidelines for cancer prevention (i.e., increase in intake of fruits, vegetables, and whole grains, and decrease in intake of processed food, red and processed meat, and sugar sweetened beverages). Using a two-arm design, participants will be randomized to receive the "Eatwell" intervention or traditional nutrition education. 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.
Aim 1: Test the hypothesis that there will be a greater increase in adherence to dietary guidelines for cancer prevention among index participants in the Eatwell condition, compared to the traditional nutrition condition. The primary outcome will be a total dietary adherence score, calculated using NCI's standardized scoring system. Grams per day of fruit, vegetables, and fiber; percentage of calorie intake from ultra-processed foods; grams per week of red meat and processed meat; and grams per day of SSBs will be examined individually as secondary outcomes.
Aim 2: Test the hypothesis that there will be greater improvements in biomarkers of inflammation among index participants in the Eatwell condition, compared to the traditional nutrition condition.
Aim 3: Test the hypothesis that adult household members will have greater improvements in dietary adherence (measured by total dietary adherence score, as well as change in individual components of dietary quality, as in Aim 1) when their index participant is randomized to the Eatwell condition, compared to the traditional nutrition condition.
Aim 4: Examine biopsychosocial mediators and moderators of intervention effects.
Aim 5: Exploratory analyses also will be conducted to, for example, examine change over time in the variables assessed as part of the study's assessment battery, understand predictors of change over time, and understand how independent or dependent variables are related to each other.
- Conditions
- Cancer Prevention, Dietary Guidelines
- Being tested
- Eatwell, Nutrition Education Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EatwellBehavioural
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.
Nutrition Education Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Eatwell Condition | Experimental | Index participant and household members receive Eatwell intervention Receives: Behavioral: Eatwell |
| Comparison Condition | Active comparator | Index participants receive nutrition education sessions; household members receive no intervention contact Receives: Other: Nutrition Education Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6, 18 months
Secondary outcomes (3)
Intake of targeted food groups
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 each food recall with the participant via videoconference, unless a participant indicates that they prefer to complete it independently. The data collected from the ASA24 will be used to examine change in intake of the individual components of the WCRF/AICR guidelines, including grams per day of fruit and vegetables, grams per day of fiber, percentage of calorie intake from ultra-processed foods, grams per week of red meat and processed meat, and grams per days or sugar sweetened drinks.
Measured: 0, 6, 18 months
Inflammation
Inflammation will be measured, for index participants only, with two biomarkers. Interleukin-6 (IL-6) is a pleiotropic cytokine that plays an important role in the proliferation and differentiation of cells. C-reactive protein (CRP) is produced by the liver in response to circulating inflammatory mediators. CRP measurement will be done with high sensitivity analyses, which detect lower levels of protein than the standard assay. Participants will be asked not to engage in vigorous exercise or weightlifting in the 24 hours prior to the test. At each assessment point, participants will be given a self-report questionnaire to capture acute or chronic conditions that could bias IL-6 or CRP results, such as infection, injury, or certain diseases. This information will be reviewed by study staff blinded to condition to determine if any inflammation data points should be excluded from analyses.
Measured: 0, 6, 18 months
Dietary quality
Index participants and their designated household members will each complete the Diet History Questionnaire-III (DHQ-III) once at each assessment point. The DHQ-III is a self-report survey that is completed online via an NCI website. This measure yields a total Healthy Eating Index-2015 (HEI-2015) score as well as specific subcomponents relevant to WCRF/AICR recommendations, such as added sugars.
Measured: 0, 6, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start10 Feb 2026
- Primary completion31 Oct 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Meghan Butryn, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225881
- Sponsor's protocol ID
- R01CA288323
- Other IDs
- R01CA288323
- Status last verified
- Mar 2026
- First submitted
- 31 Oct 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified data will be placed in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multi-level Intervention Designed to Promote Adherence to WCRF/AICR Dietary Guidelines for Cancer Prevention
- ClinicalTrials.gov ID
- NCT07225881
- Acronym / sponsor ID
- R01CA288323
- Conditions
- Cancer Prevention, Dietary Guidelines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to test an intervention that is designed to facilitate adherence to the dietary guidelines for cancer prevention (i.e., increase in intake of fruits, vegetables, and whole grains, and decrease in intake of processed food, red and processed meat, and sugar sweetened beverages). Using a two-arm design, participants will be randomized to receive the "Eatwell" intervention or traditional nutrition education. 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.
Aim 1: Test the hypothesis that there will be a greater increase in adherence to dietary guidelines for cancer prevention among index participants in the Eatwell condition, compared to the traditional nutrition condition. The primary outcome will be a total dietary adherence score, calculated using NCI's standardized scoring system. Grams per day of fruit, vegetables, and fiber; percentage of calorie intake from ultra-processed foods; grams per week of red meat and processed meat; and grams per day of SSBs will be examined individually as secondary outcomes.
Aim 2: Test the hypothesis that there will be greater improvements in biomarkers of inflammation among index participants in the Eatwell condition, compared to the traditional nutrition condition.
Aim 3: Test the hypothesis that adult household members will have greater improvements in dietary adherence (measured by total dietary adherence score, as well as change in individual components of dietary quality, as in Aim 1) when their index participant is randomized to the Eatwell condition, compared to the traditional nutrition condition.
Aim 4: Examine biopsychosocial mediators and moderators of intervention effects.
Aim 5: Exploratory analyses also will be conducted to, for example, examine change over time in the variables assessed as part of the study's assessment battery, understand predictors of change over time, and understand how independent or dependent variables are related to each other.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eatwell Condition | Experimental | Behavioral: EatwellIndex participant and household members receive Eatwell intervention |
| Comparison Condition | Active comparator | Other: Nutrition Education Control GroupIndex participants receive nutrition education sessions; household members receive no intervention contact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EatwellThe 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. | Behavioural | Eatwell Condition |
| Nutrition Education Control GroupIn 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. | Other | Comparison Condition |
Primary outcome
Total dietary adherence score
Time frame: 0, 6, 18 months
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.
3 secondary outcomes
Intake of targeted food groups
Time frame: 0, 6, 18 months
Inflammation
Time frame: 0, 6, 18 months
Dietary quality
Time frame: 0, 6, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. All deidentified data will be placed in a public repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eatwell in people with Cancer Prevention and Dietary Guidelines, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator, BA (724-619-1461, aeu26@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dietary adherence score (time frame: 0, 6, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.