Maureen Black, Ph.D. Sylvia Fernandez Rao , Ph.D. Kristen Hurley, Ph.D. Shahnaz Vazir , Ph.D.

1. Integrating Nutrition and Child Development Interventions Among Infants in Rural India: Lessons from the Field Maureen Black, Ph.D. Sylvia Fernandez Rao, Ph.D. Kristen Hurley, Ph.D. ShahnazVazir, Ph.D. Kim Harding, MPH Nick Tilton, MPH Madhaven Nair, Ph.D. NagallaBalakrishna, Ph.D. SeshikiranBoindala, MD Radha Krishna, MD Greg Rheinhart, Ph.D.

3. Objectives • To evaluate if an intervention of multiple micronutrients (MMN) and early stimulation (play & communication) enhances child development • To facilitate scaling up by using village level workers and Anganwadi Centers • Background • Theory • Design • Management • Implementation and status

4. 2007 Lancet Series on Child Development • More than 200 million children under age 5 years in low- and middle-income countries do not reach their developmental potential • Major risks for poor child development • Chronic undernutrition • Nutritional deficiencies (iron, iodine) • Lack of stimulating opportunities • Evidence on effective early interventions

5. % of disadvantaged children by country

6. 2011 Lancet Series on Child Development • Inequality in early childhood: risk and protective factors for early child development. • Reviews new evidence on: • causes of developmental inequality • effective interventions to promote child development • Strategies for reducing inequalities and improving developmental outcomes. • Priorities for early childhood policies and programs to reduce inequalities • Estimates the cost of not investing in early childhood programs

7. Worldwide timing of growth faltering from 54 countries 1000 days Victora et al. Pediatrics 2010;125:e473-e480

8. Stunting in children <5years X-sectional associations between stunting & poor cognition or school achievement

9. Cognitive or schooling deficits associated with moderate stunting <3yrs in 6 longitudinal studies Philippines S Africa Indonesia Brazil Peru Jamaica deviation scores

10. The developing brain • The brain develops through dynamic interactions of genetic, biological, and psychosocial influences and child behavior • Exposure to biological and psychosocial risks (toxic stress) leads to deficits in brain structure and function, and pervasive impairments in educational outcome, mental and physical health, and overall well-being • Disparities increase with early, multiple, and cumulative risks

11. Iron Deficiency • Most prevalent single nutrient deficiency in the world • ~35% • Leading cause of anemia • Associated with deficits in motor, cognitive & socioemotional behavior • May affect brain functions • Myelination • Dopamine • Norepinephrine metabolism

12. 1000 days Iron: 0.27 mg/day 11 mg/day 7 mg/day 0–6 months 6-12 months 1-3 years Thompson & Nelson, 2000

13. Psychosocial risks • Lack of learning opportunities and poor quality caregiver-child interaction – major risk for poor development • Brain architecture develops in the context of relationships • Protective influences that promote child development • responsive caregiver-child interaction • opportunities for young children to play and learn

14. Nutrition and health are necessary, but not sufficient for early child development Substantial gains in children’s development require: • Improvements in parenting, stimulation and early education • Reductions in stressful experiences through psychosocial support for children and families affected by societal violence

15. Development of inequality 1000 days

16. Social-Ecological Theory Distal threats and opportunities reach the child through proximal interactions between child & family Bronfenbrenner & Ceci, 1994

17. Poverty Lack of Stimulation Motor Dev Low quality diet Cognitive Dev Parent-Child Interaction Socio- Emotional Dev Child Iron Deficiency Intervene Outcome Mediators

18. MMN Sachets Play & Commun MMN Sachets Vit Sachets (Placebo) Play & Commun Project Grow Smart (India) Vit Sachets (Placebo) • Home Infant Phase (6-12 months: 1 year RCT) • Preschool Phase (3-5 years: 1 year RCT) • Anganwadi Centers (AWC): preschoolers • MMN or Placebo – food provided at AWC • Collaborators • National Institute of Nutrition (Hyderabad), Univ of Maryland, Micronutrient Initiative, Mathile Institute

19. Formative Phase • Ensure culturally and developmentally appropriate material, messages, and methods • Focus groups • Consultation with village workers and leaders • Mothers wanted children to be smart – thus the title “Grow Smart”

20. Assessed Acceptability of MMN When mixed with 50g (1 fist) of soft and smashed rice with pulse or milk, MMN formulation acceptable: Color Smell Texture Taste

21. Assessed Feasibility of Play/Communication Intervention Feasibility of play and communication intervention assessed to be high, based on pilot testing and consultation with other agencies

22. Formal Approvals • Approvals obtained from: • National Institute of Nutrition, India • Institutional Review Board, University of Maryland • Health Ministry Screening Committee, India • India Council of Medical Research • Department of Women and Child Development, India • Local village leaders • Local Anganwadi Centers

23. Conclusion • An intervention trial using local village level workers (VLW) to promote nutritional status and child development through MMN and a play/communication intervention delivered in the home for infants and AWC for preschoolers is: • needed • acceptable • feasible • approved

24. Intervention Strategy • Infancy Phase • Home Visits • Nutrition Intervention (MMN messages) – Universal • Play and Communication Intervention – Randomized • Distribution of MMN/Placebo sachets (blinded) • Preschool Phase • Anganwadi Center • Government-sponsored childcare centers, food • Nutrition Intervention (MMN messages) – Universal • Distribution of MMN/Placebo food (blinded) • Quality determined by ECERS – Early Childhood Environmental Rating Scale, Modified

25. MMN Fortification

26. Play and Communication Intervention • Infant Phase (Flip Charts) • Trial informed by: • Social-Ecological Theory (Bronfenbrenner & Ceci, 1994) • Care for Development (WHO, 2001) • Pakistan Early Development Study (Yousafzai, 2010) • Preschool Phase • No trial • Early Childhood Environmental Rating Scale, Modified (ECERS)

27. VISIT 7 Play peek- a- boo with your child

28. VISIT 7 (age 9-11) NEW MESSAGE: Play peek- a- boo with your child (SHOW PICTURE) EXPLANATION: [CHILD] will love to play games with you. Remember [CHILD] is always learning. Things that seem simple to you will be amusing as well as rewarding to the child. Play games like peek-a-boo and clapping hands with your child. He will enjoy it immensely and will learn to play with others as well. ACTIVITY: • Using your hands or the pallu of your sari to cover and uncover your face. Tell [CHILD] ‘Here I am’ when your face is uncovered. Vary where you reappear (to the left, right, top, bottom). • Place [CHILD] in front of a mirror. Put a piece of cloth between her face and the mirror and then remove it. Repeat the action, so the child appears and disappears, while saying “Where is [CHILD]?”. DEMONSTRATE AND PRACTICE ACTIVITIES (PRAISE, PROBLEM SOLVE, ENCOURAGE) CHECKING QUESTIONS: • What games are you familiar with? When do you play them? How does your child react? • When can you and your family play these types of games with your child? MOTIVATION: Your child will enjoy interactive games. She will laugh and develop a sense of presence and absence, as she anticipates where you will appear. These activities will help her learn to focus and she will feel good about playing them with you and good about herself. The games will help her attention span so she can focus on learning.

29. Nutrition Intervention • Flip Charts • Informed by: • Indo-US Study (Vazir, 2012)

30. Give dark green or orange vegetables and fruits daily Reminder

31. VISIT 10 REINFORCE MESSAGE: Give dark green or orange vegetables and fruits daily or as often as possible (SHOW PICTURE) FLIP CHART ACTIVITY (SHOW PICTURE): Ask mother to point to dark green or orange vegetables and fruits that her family commonly eats. CHECKING QUESTIONS: • What vegetables have you been giving to [INFANT]? • What fruits have you been giving to [INFANT]? • How have you been preparing them for [INFANT]? (If yes PRAISE; if not,ENCOURAGE the mother to prepare vegetables and fruits for her baby) MOTIVATION: • [INFANT] will like food with fruits and vegetables in them and will stay healthier and become smarter REMINDERS: • Before preparing food and feeding [INFANT], wash your hands with soap and water.Washing gets rid of germs that can make [INFANT] sick. At this age, children like to pick up food and feed themselves/ or put their fingers in their mouth. Wash their hands to avoid germs.

32. Evaluations • Mother • Feeding practices • Child’s dietary intake • Maternal depressive symptoms & parenting stress • Maternal iron status • Demographics (education, marital status, assets, etc.) • Child • Anthropometry • Iron, zinc status • Cognitive, motor, social-emotional development • Inhibitory control • Mother-child • Video-taped play observation • HOME Inventory

33. Management • Ethical procedures • Operations manual • Tracking system • Supervisory structure • Criteria for reliability (intervention and evaluation) • Regularly scheduled training/feedback/re-training • Systematic data entry, cleaning, back-up • Transparency

34. Investigators Management Structure Data Management/Analysis Project Coordinator Data Entry/Cleaning Evaluation Team Lead Psychologist Psychologists Intervention Team Lead Interventionist Medical Team Physician Village Level Worker Supervisors Phelobotomists Village Level Workers Anthropometrists

35. Management Processes • Investigators • Weekly/biweekly conference calls with agenda & minutes • Shared electronic communication: Drop Box • Includes all protocols, consent forms, background articles, evaluation material, intervention material, correspondence • Dated and available to entire team of investigators • Periodic face-to-face visits, scheduled with specific goals • India Team • Tracking system to handle schedules • Field visits 4 days/week. Meetings/office/updated shedules on Friday • Timely feedback

36. Monitoring and Evaluation • Infant Phase • VLW workers record quality of intervention contact • Checklist/observation of VLW workers by VLW Supervisors • Motivational Interviewing techniques • Demonstration and modeling • Conversational and listening to mother (not reading) • Checklist/observation of VLW Supervisors by Lead Interventionist • Preschool Phase • AWC teacher records attendance and amount of food eaten • Checklist/observation of AWC teacher by VLW Supervisors

37. Status • Infant Phase • Completed enrollment & baseline evaluation • Intervention ongoing • Preschool Phase • Completed training • Pilot testing ongoing • Enrollment & baseline about to begin • Timeline • Infant phase: through ~ June 2013 • Preschool phase: through ~ September 2013