Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer - Female
- Diet, Healthy
- Inflammation
- Postpartum Weight Retention
- Risk Reduction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: Key laboratory analyses will conducted by laboratories blinded to intervention arm.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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. T...
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.
Tracking Information
- NCT #
- NCT04374747
- Collaborators
- National Cancer Institute (NCI)
- 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