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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)

From: Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial

Outcomes

Allocation

Study period

Enrollment

 

Close-out

-t1

Baseline (t0)

Intervention

(8 months)

Midline at month 1 after delivery (t1)

End line at month 6 (t2)

Enrollment

 Allocation

x

    

 Eligibility screen

 

x

   

 Informed consent

 

x

   

Interventions

 BFES Intervention

  

x

  

 Control group

  

x

  

Assessments

 Background/demographics

 

x

   

 Water, Hygiene and Sanitation

 

x

   

 Household Food Insecurity Access Scale

 

x

   

 Food Taboos during Pregnancy & Lactation

 

x

   

 Mother’s Health Status & Obstetric history

 

x

   

 Current pregnancy and breastfeeding

 

x

   

 Timely breastfeeding initiation

   

x

 

 Exclusive breastfeeding at 6 month

    

x

 Infant growth

    

x

 Validation of the Afan Oromo version breastfeeding knowledge and attitude questionnaire

  

x

  

 Baseline knowledge, attitude and practice of mothers on breastfeeding

  

x

  

 Change in mothers’ knowledge and attitude towards breastfeeding at baseline and study completion

  

x

 

x

 Mothers' and WDA leaders' experiences of the intervention at study completion

    

x