- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04374747
Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk
Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
- Informed Consent document administered.
- Public Data Sharing Informed Consent document administered.
- Three questionnaires: New Moms Health, Physical Activity, and Breastfeeding Practices
- Maternal height, weight, and waist circumference measured.
- Instructions provided for future collection of biospecimens.
- Complete one 24-Hour Dietary Recall
- Instructions provided for two additional 24-Hour Dietary Recalls.
Visit 2 Sample Collection 1 (1.5 hours) Occurs at 6 weeks postpartum
- Provide bilateral breast milk samples and completed questionnaire.
- Provide infant stool sample and completed questionnaire.
- Two questionnaires: Infant Feeding, and Medication & Supplement
- Infant length and weight measured.
- Maternal and infant skin carotenoids measured.
- Nutrition education provided.
- Optional collection of maternal stool sample and completed questionnaire.
Visit 3 Sample Collection 2 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 16 weeks postpartum
- Provide bilateral breast milk samples and completed questionnaire.
- Provide infant stool sample and completed questionnaire.
- Three questionnaires: Physical Activity, Infant Feeding, and Medication & Supplement
- Infant length and weight measured.
- Maternal weight and waist circumference measured.
- Maternal and infant skin carotenoids measured.
Visit 4 Sample Collection 3 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 26 weeks postpartum
- Provide bilateral breast milk samples and completed questionnaire.
- Provide infant stool sample and completed questionnaire.
- Three questionnaires: Physical Activity, Infant Feeding, and Medication & Supplement.
- Infant length and weight measured.
- Maternal weight and waist circumference measured.
- Maternal and infant skin carotenoids measured.
- Optional collection of maternal stool samples and completed questionnaire.
Visit 5 Sample Collection 4 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 58 weeks postpartum
- Provide bilateral breast milk samples and completed questionnaire.
- Provide infant stool sample and completed questionnaire.
- Four questionnaires: Physical Activity, Infant Feeding, Medication and Supplement, and Breast Health
- Infant length and weight measured.
- Maternal weight and waist circumference measured.
- Maternal and infant skin carotenoids measured.
- Optional collection of maternal stool samples and completed questionnaire.
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
- Three questionnaires: Physical Activity, Breast Health, Young Child Feeding
- Infant height and weight measured.
- Maternal weight and waist circumference measured.
- Maternal and infant skin carotenoids measured.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathleen Arcaro, PhD
- Phone Number: 413-577-1823
- Email: karcaro@umass.edu
Study Contact Backup
- Name: Susan Sturgeon, DrPH
- Phone Number: 413-577-1364
- Email: ssturgeon@schoolph.umass.edu
Study Locations
-
-
Massachusetts
-
Amherst, Massachusetts, United States, 01003
- Recruiting
- University of Massachusetts Amherst
-
Contact:
- Kathleen Arcaro, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have given birth in past five weeks or are currently pregnant
- Breastfeeding baby at entry into the study
- Consuming five or fewer servings of fruits and vegetables daily at baseline
- Live within 25 miles of Amherst MA
Exclusion Criteria:
- Invasive breast cancer
- Any cancer except non-melanoma skin cancer in past five years
- History of Crohn's disease, celiac sprue, or other malabsorption syndrome, which may interfere with digesting or absorption of nutrients
- A personal history of diabetes (excluding gestational diabetes)
- Baseline BMI of <18.5
- Dietary restrictions that prevent participant from eating 8 to 10 servings of fruits and vegetables
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dietary Intervention
Intensive dietary counseling and fruit and vegetable box delivery.
|
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 .
|
NO_INTERVENTION: Information
Control condition of information on healthy eating during breastfeeding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DNA methylation
Time Frame: 20 weeks
|
% methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk
|
20 weeks
|
Inflammatory markers in milk
Time Frame: 20 weeks
|
Adiponectin, CRP, IFN-y, IL1-beta, Leptin, IL-6, IL-8, TNF-alpha, b-FGF, FLT-1, PLGF, VegF-D
|
20 weeks
|
Early weight
Time Frame: 20 weeks
|
maternal weight
|
20 weeks
|
Early waist circumference
Time Frame: 20 weeks
|
maternal waist circumference
|
20 weeks
|
One-year Weight
Time Frame: One-year
|
maternal weight
|
One-year
|
One-year Waist Circumference
Time Frame: one year
|
maternal weight circumference
|
one year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fruit and Vegetable Intake
Time Frame: one year
|
servings per day
|
one year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kathleen Arcaro, PhD, University of Massachusetts, Amherst
- Principal Investigator: Lindiwe Sibeko, PhD, University of Massachusetts, Amherst
- Principal Investigator: Susan Sturgeon, DrPH, University of Massachusetts, Amherst
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-5382
- 1R01CA230478-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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