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Table 5 Schedule of activities/ interventions for subjects by week of study participation

From: Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial

 

Study Period

Enrollment

         

Week

0

2

4

6

8

Third trimester

Delivery

6 weeks post-partum

3 months post-partum

6 months post-partum

Enrollment:

          

 Eligibility Screen

X

         

 Informed consent

X

         

 Socio-demographic questions

X

         

Assessments:

X

   

X

     

 HFIASa, Food frequency questionnaire

X

   

X

     

 Clinic visit for intervention and control food supply

X

X

X

X

X

     

 Adherence/educational messages

X

X

X

X

X

     

 Surveillance of clinical events

X

X

X

X

X

     

 Maternal anthropometric measurements

X

X

X

X

X

     

 Infant anthropometric measurements

      

X

X

X

X

Interventions:

          

 Food distribution

X

X

X

X

X

X

    

 Bed net distribution

X

         

 Testing and treatment of bacterial vaginosis

X

    

X

    

 Albendazole (400 mg)

X

         

 Azithromycin (1 g)

X

    

X

    

 Sulfadoxine/ pyrimethamine (1500 mg/75 mg)

X

 

X

 

X

X

    
  1. aHFIAS household food insecurity assessment scale