An interventional study of Eatwell and Nutrition Education Control Group in Cancer Prevention and Dietary Guidelines, sponsored by Drexel University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Drexel University · Not applicable, Interventional, and 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.
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.
Drexel University is the lead sponsor of 113 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Index participant and household members receive Eatwell intervention
Behavioral: Eatwell
Index participants receive nutrition education sessions; household members receive no intervention contact
Other: Nutrition Education Control Group
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.
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.
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.
Time frame: 0, 6, 18 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 0, 6, 18 months
Participant age
Age at baseline will be self reported
Time frame: 0 months
Participant weight
Baseline weight will be self reported in pounds
Time frame: 0 months
Participant height
Height will be self reported in feet and inches
Time frame: 0 months
Participant race
Race will be self reported
Time frame: 0 months
Participant ethnicity
Ethnicity will be self reported
Time frame: 0 months
Participant gender
Gender will be self reported
Time frame: 0 months
Participant biological sex
Biological sex will be self reported
Time frame: 0 months
Participant household income
Household income at baseline will be self reported
Time frame: 0 months
Objectively measured weight
Each index participant will be provided with a Withings wireless scale, accurate to \>0.2 kg, that transmits information directly to study staff. Scale information will be piped from the device to REDCap. Participants will be instructed to weigh themselves in the morning, after voiding urine but before eating, for three consecutive days at each assessment point, with the scale on a flat, hard surface. Data will be checked for outliers and averaged at each time point for each participant. BMI will be calculated based on self-reported height and objectively measured weight.
Time frame: 0, 6, 18 months
Physical Acitvity
Physical activity will be measured with the International Physical Activity Questionnaire (Short-Form).
Time frame: 0, 6, 18 months
Food insecurity
This will be assessed with the USDA's Household Food Security Survey and will be dichotomized as food secure vs. low or very low security.
Time frame: 0 months
Neighborhood food environment
The neighborhood food environment will be assessed through the use of the modified Retail Food Environment Index (mRFEI) score, sourced from the CDC and census tract. Participant addresses will be used to determine their mRFEI score.
Time frame: 0 months
The proportion of meals and snacks sourced from grocery stores
This will be measured with the "Source" module on ASA24 food recalls, which tags each food entry with a source (e.g., convenience store, fast food, street vendor, etc.). Participants will be categorized into tertiles based on proportion of diet sourced from grocery stores.
Time frame: 0, 6, 18 months
Treatment Acceptability
Treatment Acceptability will be measured at 6 and 18 months using the Treatment Acceptability Questionnaire. This measure was created by the study team.
Time frame: 6, 18 months
Self-regulation
To measure use of self-regulation strategies, participants will be asked to rate the frequency with which they used each strategy in the past month. Change in use of intervention-targeted strategies will be examined.
Time frame: 0, 6, 18 months
Hedonic hunger
Hedonic hunger will also be measured through the Power of Food Scale.
Time frame: 0, 6, 18 months
Autonomous Motivation
Autonomous motivation for dietary change will be examined with the Treatment Self-Regulation Questionnaire.
Time frame: 0, 6, 18 months
Supportive Accounability
Supportive accountability will be measured with the dietary items of the Supportive Accountability Measure.
Time frame: 0, 6, 18 months
Social Support
Social support for healthy eating from household members will be measured with select items adapted from Sallis's Social Support for Diet Survey and the Quality of Interactions survey.
Time frame: 0, 6, 18 months
Plan to share: Yes — All deidentified data will be placed in a public repository.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Within 12 months after study completion.
Access criteria: Public availability
Data sharing details ↗ · drexel.edu
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