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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA230478-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Mechanistic data show that compounds in fruits and vegetables have anti-inflammatory and anti-carcinogenic properties that can reduce breast cancer risk. However, observational and interventional studies have provided mixed results, and a recent report by the American Institute for Cancer Research (AICR) concludes that the data are insufficient but suggestive that non-starchy vegetables and foods containing carotenoids reduce risk. Measurement error, relatively low levels of carotenoid-rich fruit and vegetable intake in the study populations, emphasis on diet in later adulthood, and confounding factors likely contribute to the weak associations. Therefore, the investigators will conduct a randomized diet intervention trial in young women to assess the extent to which at least 8 to 10 daily servings of deeply pigmented and nutrient dense fruits and vegetables reduces biomarkers of breast cancer risk. The intervention is focused on breastfeeding women because: 1) pregnancy and lactation are normal early life course events; 2) the risk of pregnancy-associated breast cancer (PABC) is increased for up to 10 years postpartum; 3) a dietary intervention to reverse the detrimental molecular changes associated with puberty and pregnancy is more likely to be successful in younger than in older women;4) a diet rich in fruits and vegetables is hypothesized to reduce the inflammation during lactation/weaning and lower PABC risk; 5) postpartum lactating women may be a highly motivated population; and 6) breastmilk provides access to the breast microenvironment and breast epithelial cells to non-invasively assess the diet intervention directly in the breast. Four hundred nursing mothers will be randomly assigned to either the intervention arm, in which they are asked to increase fruit and vegetable intake to at least 8 to 10 daily servings for one year, or to a control condition in which participants receive a dietary guideline for breastfeeding mothers. Women in the intervention arm will receive counseling and boxes of fruits and vegetables for the first 20 weeks, after which they will continue to receive counseling. Changes in DNA methylation and cytokine profiles in breastmilk will be evaluated. Maternal weight and body fat distribution, and infant growth will be monitored. These results will greatly expand our knowledge of how diet alters molecular pathways in a specific organ, ultimately contributing to both breast cancer etiology and prevention.
Overview of home visits and activities completed by all participants
Visit 1 Introductory Visit (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 5 weeks postpartum
Visit 2 Sample Collection 1 (1.5 hours) Occurs at 6 weeks postpartum
Visit 3 Sample Collection 2 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 16 weeks postpartum
Visit 4 Sample Collection 3 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 26 weeks postpartum
Visit 5 Sample Collection 4 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 58 weeks postpartum
Annual Follow-up Visit (Maximum of 2) (1 hour) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at one-year intervals after Visit 5
Monthly Inquiry (1 - 2 minutes) Occurs monthly until no longer breastfeeding
• Complete the Breast Feeding Update Questionnaire online via a survey sent through REDCap, or through a phone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Intervention | Experimental | Intensive dietary counseling and fruit and vegetable box delivery. |
|
| Information | No Intervention | Control condition of information on healthy eating during breastfeeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Counseling | Behavioral | The counseling approach will employ strategies shown to be successful in previous and ongoing dietary modification studies including supportive and motivational interviewing techniques. Each woman in the diet intervention group will be assigned a trained nutrition coach/counselor. Counselors will focus on helping participants identify and address barriers to achieving the goal of consuming at least 8 to 10 servings of nutrient dense fruits and vegetables each day (e.g., modifying recipes and food preparation). Participants will also receive weekly boxes of fruits and vegetables . |
| Measure | Description | Time Frame |
|---|---|---|
| DNA methylation | % methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk | 20 weeks |
| Inflammatory markers in milk | Adiponectin, CRP, IFN-y, IL1-beta, Leptin, IL-6, IL-8, TNF-alpha, b-FGF, FLT-1, PLGF, VegF-D | 20 weeks |
| Early weight | maternal weight | 20 weeks |
| Early waist circumference | maternal waist circumference | 20 weeks |
| One-year Weight | maternal weight | One-year |
| One-year Waist Circumference | maternal weight circumference | one year |
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| Measure | Description | Time Frame |
|---|---|---|
| Fruit and Vegetable Intake | servings per day | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Arcaro, PhD | Contact | 413-577-1823 | karcaro@umass.edu | |
| Susan Sturgeon, DrPH | Contact | 413-577-1364 | ssturgeon@schoolph.umass.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Arcaro, PhD | University of Massachusetts, Amherst | Principal Investigator |
| Lindiwe Sibeko, PhD | University of Massachusetts, Amherst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Amherst | Recruiting | Amherst | Massachusetts | 01003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30213617 | Background | Essa AR, Browne EP, Punska EC, Perkins K, Boudreau E, Wiggins H, Anderton DL, Sibeko L, Sturgeon SR, Arcaro KF. Dietary Intervention to Increase Fruit and Vegetable Consumption in Breastfeeding Women: A Pilot Randomized Trial Measuring Inflammatory Markers in Breast Milk. J Acad Nutr Diet. 2018 Dec;118(12):2287-2295. doi: 10.1016/j.jand.2018.06.015. Epub 2018 Sep 10. | |
| 36153518 | Derived | Sturgeon SR, Sibeko L, Balasubramanian R, Arcaro KF. New Moms Wellness Study: the randomized controlled trial study protocol for an intervention study to increase fruit and vegetable intake and lower breast cancer risk through weekly counseling and supplemental fruit and vegetable box delivery in breastfeeding women. BMC Womens Health. 2022 Sep 24;22(1):389. doi: 10.1186/s12905-022-01967-9. |
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There is no plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D000078064 | Gestational Weight Gain |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Key laboratory analyses will conducted by laboratories blinded to intervention arm.
|
| Susan Sturgeon, DrPH |
| University of Massachusetts, Amherst |
| Principal Investigator |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |