Evidence map›Paper›PMID 36153518›Full record

ArticleBMC women's health2022

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.

Susan R Sturgeon, Lindiwe Sibeko, Raji Balasubramanian, Kathleen F Arcaro

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC women's health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04374747 (Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04374747 naunknown statusnot on this map

Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight

TypeinterventionalSponsorUniversity of Massachusetts, AmherstRan2019 to 2024Enrolled400ConditionsBreast Cancer Female, Inflammation, Postpartum Weight Retention, Diet, HealthyArmsDietary Counseling
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Omics-Based Investigations of Breast Cancer.Molecules (Basel, Switzerland) · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Susan R Sturgeon *Department of Biostatistics and Epidemiology, School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, 01003, USA. ssturgeon@schoolph.umass.edu.ORCID 0000-0001-9032-871X
Lindiwe Sibeko *Department of Nutrition, School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, 01003, USA.
Raji BalasubramanianDepartment of Biostatistics and Epidemiology, School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, 01003, USA.
Kathleen F Arcaro *Department of Veterinary and Animal Sciences, College of Natural Sciences, University of Massachusetts, Amherst, MA, 01003, USA.
University of Massachusetts Amherst · US

Funding

Fruit and vegetable intervention in lactating women to reduce breast cancer risk: effects on breast cell DNA methylation, breast inflammation, and weightR01CA230478 · NCI · UNIVERSITY OF MASSACHUSETTS AMHERST · PI ARCARO, KATHLEEN FRANCES, SIBEKO, LINDIWE N · 2019 to 2023
$3.2M
NCI NIH HHS R01 CA230478
6 · The paper itself

Abstract

backgroundLaboratory 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.

methodsEligible 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 registrationClinicalTrials.gov Identifier: NCT04374747. Registered May 5, 2020. https://www. CLINICALTRIALS: gov/ct2/show/NCT04374747 .

Indexed as

Breast NeoplasmsVegetablesAdultBiomarkersBreast FeedingCounselingDietFemaleFruitHumansInfantRandomized Controlled Trials as TopicBiomarkersBreast cancerDietDNA methylationFruitInflammatory markersVegetables

Identifiers

PMID36153518
PMCPMC9509588
OpenAlexW4297186127

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.