Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
472 participants
INTERVENTIONAL
2026-01-01
2029-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Eatwell Condition
Index participant and household members receive Eatwell intervention
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.
Comparison Condition
Index participants receive nutrition education sessions; household members receive no intervention contact
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Drexel University
OTHER
Responsible Party
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Meghan Butryn
Professor, Department of Psychological and Brain Sciences
Locations
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Drexel University
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Anna Upman, BA
Role: primary