Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
NCT ID: NCT05984888
Last Updated: 2025-10-03
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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RECRUITING
NA
43 participants
INTERVENTIONAL
2023-10-26
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MIND-BC Intervention Group
Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.
MIND Diet Intervention Group
Participants will receive individually tailored nutrition counseling on adopting the MIND diet pattern from a registered dietitian nutritionist (RDN) for a total of 8 sessions spanning 12 weeks. After completing the counseling sessions participants will be followed up 6 months later to collect additional questionnaires and assessments.
General Health Curriculum (GHC) Control
Sessions of non-diet related health topic education.
General Health Curriculum (GHC) Group
Participants will meet with trained study staff for 8 sessions spanning 12 weeks covering content on non-diet related health topics. After these sessions, participants will be followed up 6 months later to collect additional questionnaires and assessments. Once 6-month follow-up has been completed, participants will be offered to receive the MIND diet intervention offered in the MIND Diet Intervention Group.
Interventions
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MIND Diet Intervention Group
Participants will receive individually tailored nutrition counseling on adopting the MIND diet pattern from a registered dietitian nutritionist (RDN) for a total of 8 sessions spanning 12 weeks. After completing the counseling sessions participants will be followed up 6 months later to collect additional questionnaires and assessments.
General Health Curriculum (GHC) Group
Participants will meet with trained study staff for 8 sessions spanning 12 weeks covering content on non-diet related health topics. After these sessions, participants will be followed up 6 months later to collect additional questionnaires and assessments. Once 6-month follow-up has been completed, participants will be offered to receive the MIND diet intervention offered in the MIND Diet Intervention Group.
Eligibility Criteria
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Inclusion Criteria
* Post-menopausal (defined as at least 1-year post menses, on ovarian suppression medication, or s/p oophorectomy)
* Within 4 weeks before or 12 weeks after starting initial systemic therapies (e.g. chemotherapy, targeted therapies such as CDK4/6 inhibitors, endocrine therapy)
* Ability to access and use internet resources, including video calls using Zoom platform
* English speaking
Exclusion Criteria
* MIND diet score \>8
* Unwilling/unable to eat \>2 types of MIND food
* Receiving insulin therapy for diabetes
* Diagnosis of triple negative breast cancer
* Unable to give informed consent.
45 Years
75 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Tonya Orchard
Principal Investigator
Principal Investigators
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Tonya S Orchard, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The Jamesline
Other Identifiers
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OSU-22367
Identifier Type: -
Identifier Source: org_study_id
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