New Moms Wellness Study: 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.

TitleNew Moms Wellness Study: 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.
Publication TypeJournal Article
Year of Publication2022
AuthorsSturgeon, SR, Sibeko, L, Balasubramanian, R, Arcaro, KF
JournalBMC Womens Health
Volume22
Issue1
Pagination389
Date Published2022 09 24
ISSN1472-6874
KeywordsAdult, Biomarkers, Breast Feeding, Breast Neoplasms, Counseling, Diet, Female, Fruit, Humans, Infant, Randomized Controlled Trials as Topic, Vegetables
Abstract

BACKGROUND: Laboratory studies indicate that chemicals in fruits and vegetables have anti-carcinogenic and anti-inflammatory activities that can lower breast cancer risk. However, epidemiologic studies of the association between fruit and vegetable intake and breast cancer risk have produced mixed results. Measurement error, confounding, and an emphasis on diet in later adulthood may contribute to weak associations. This paper describes a randomized controlled diet intervention trial in breastfeeding women to examine the effect of high fruit and vegetable intake on breast cancer risk factors, including weight, DNA methylation and inflammatory markers.

METHODS: Eligible breastfeeding women who reside within a 35-mile radius of Amherst, MA are enrolled at five to six weeks postpartum and randomly assigned to a Fruit and Vegetable Intervention Arm (target n = 200) or to a USDA MyPlate Control Arm (target n = 200). The Fruit and Vegetable Intervention group receives weekly telephone or video-based counseling to encourage intake of at least eight to ten daily servings of fruits and vegetables and a weekly delivery of a supplemental box of fruits and vegetables for 20 weeks, and less intensive counseling for up to one year. Breastmilk and infant fecal specimens are collected at baseline, 10 and 20 weeks. Anthropometric measurements are obtained at these timepoints and at the 1-year follow-up. The primary outcomes are change in DNA methylation in breast epithelial cells and change in inflammatory markers in breastmilk from randomization to 20 weeks; and change in weight, waist circumference, and fruit and vegetable intake for the period from randomization to 20 weeks and 1 year.

DISCUSSION: This 1-year randomized diet intervention trial in breastfeeding women will assess whether intake of at least eight to ten daily servings of fruits and vegetables per day improves biomarkers of breast cancer risk directly in the breast (i.e., DNA methylation and inflammatory markers) and helps women maintain a healthy weight.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04374747. Registered May 5, 2020. https://www.

CLINICALTRIALS: gov/ct2/show/NCT04374747 .

DOI10.1186/s12905-022-01967-9
Alternate JournalBMC Womens Health
PubMed ID36153518
PubMed Central IDPMC9509588
Grant ListR01 CA230478 / CA / NCI NIH HHS / United States