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Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk

Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk

Recruiting
18 years and older
Female
Phase N/A

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 details
    Risk Reduction
    Coping Behavior
    Inflammation
    Inflammation
    Breast Cancer Female
    Postpartum Weight Retention
    Diet
    Healthy

NCT04374747

University of Massachusetts, Amherst

19 February 2024

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