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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA288323 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eatwell Condition | Experimental | Index participant and household members receive Eatwell intervention |
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| Comparison Condition | Active Comparator | Index participants receive nutrition education sessions; household members receive no intervention contact |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant age | Age at baseline will be self reported | 0 months |
| Participant weight | Baseline weight will be self reported in pounds | 0 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator, BA | Contact | 724-619-1461 | aeu26@drexel.edu | |
| Meghan L Butryn, PhD | Contact | 215-553-7108 | mlb34@drexel.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
All deidentified data will be placed in a public repository.
Within 12 months after study completion.
Public availability
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| 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. |
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| 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. | 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. | 0, 6, 18 months |
| Participant height | Height will be self reported in feet and inches | 0 months |
| Participant race | Race will be self reported | 0 months |
| Participant ethnicity | Ethnicity will be self reported | 0 months |
| Participant gender | Gender will be self reported | 0 months |
| Participant biological sex | Biological sex will be self reported | 0 months |
| Participant household income | Household income at baseline will be self reported | 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. | 0, 6, 18 months |
| Physical Acitvity | Physical activity will be measured with the International Physical Activity Questionnaire (Short-Form). | 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. | 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. | 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. | 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. | 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. | 0, 6, 18 months |
| Hedonic hunger | Hedonic hunger will also be measured through the Power of Food Scale. | 0, 6, 18 months |
| Autonomous Motivation | Autonomous motivation for dietary change will be examined with the Treatment Self-Regulation Questionnaire. | 0, 6, 18 months |
| Supportive Accounability | Supportive accountability will be measured with the dietary items of the Supportive Accountability Measure. | 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. | 0, 6, 18 months |