Health TrialsbyHealthPanel

Eatwell Clinical Trial (R01)

ConditionsCancer PreventionDietary Guidelines
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDrexel University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Nutrition Education Control Group

    Other intervention

    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.

Treatment groups

472 Participants
are divided into 2 treatment groups
Group A: Eatwell ConditionExperimental treatment 1 intervention
Group B: Comparison ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

Participant age

Age at baseline will be self reported

Time frame
0 months
2

Participant weight

Baseline weight will be self reported in pounds

Time frame
0 months
3

Participant height

Height will be self reported in feet and inches

Time frame
0 months
4

Participant race

Race will be self reported

Time frame
0 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Drexel University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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