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Table 1 Schedule of procedures, assessments, and interventions

From: Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial

  

Study period

 

Pre-randomization

Intervention

Post-intervention follow-up

Post-intervention follow-up

Time point

1 weeks

0

4 months

4 months

12 months

Subjects

Screening Cohort N = 1500

RCT subjects n = 150

RCT subjects n = 150

  

INTERVENTIONS:

     

Intervention

 

X

X

  

Control

 

X

X

  

PROCEDURES: Informed consent

X

    

Eligibility screen

X

    

Randomization

 

X

   

ASSESSMENTS:

     

TARGet Kids! Child and Family Questionnaire

X

    

Laboratory measurements: Hemoglobin, serum ferritin, mean corpuscular volume (MCV), C-reactive protein (CRP)

X

  

X

X

IBQ (12-17 months infants)/ECBQ (18-36 months children)/CBQ (37-72 months children)*

X

  

X

X

Physical measurements: height and weight, waist circumference

X

  

X

X

Mullen Scales of Early Learning (MSEL)

 

X

 

X

X

4 month follow-up questionnaire

   

X

 
  1. *IBQ: Infant Behavior Questionnaire; ECBQ: Early Childhood Behavior Questionnaire; CBQ: Children’s Behavior Questionnaire.