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Table 1 Study activities at each assessment

From: 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

 

Pre-enrollment

Baseline

10 weeks

20 weeks

1 year

Eligibility

     

Informed consent

X

    

Eligibility Screener

X

    

Fruit and vegetable screener

X

    

Randomization

     

Randomization

 

X

   

Nutrition education session

 

X

   

Intervention arm only

     

Fruit and vegetable delivery (weekly for 20 weeks)

 

X

X

X

 

Dietary counseling (weekly for 20 weeks then monthly up to 1 year)

 

X

X

X

 

Three 24-Hour Diet Records (weekly for 20 weeks to guide counseling)

 

X

X

X

 

Monthly counseling check-ins (between 20 weeks and one year)

   

X

X

Anthropometrics

     

Maternal height

X

X

   

Maternal weight

X

X

X

X

X

Maternal waist circumference

 

X

X

X

X

Infant length and weight

 

X

X

X

X

Biological sample collection

     

Breastmilk specimen (if still breastfeeding)

 

X

X

X

X

Infant fecal specimen

 

X

X

X

X

Maternal fecal specimen (optional)

 

X

 

X

X

Questionnaire data

     

Three 24 hour diet recalls (ASA24)

 

X

X

X

X

Breastfeeding Practices Questionnaire

 

X

   

Breastfeeding Update Questionnaire

  

X

X

X

New Moms Health Questionnaire

 

X

   

Medication and Supplement Questionnaire

 

X

X

X

X

Infant and Child Feeding Questionnaire

 

X

X

X

X

Physical Activity Questionnaire (IPAQ)

 

X

X

X

X

Breast Health Questionnaire

    

X