Early Child Development and Nutrition in Guatemala
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Over 200 million children under the age of 5 years in low and middle-income countries do not
      reach their developmental potential, largely due to lack of adequate nutrients and lack of
      psychosocial stimulation. Stunting (length-for-age < -2 z-scores) is an indication of chronic
      undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere (over
      40%). This trial examines the effect of providing a micronutrient powder manufactured in
      Guatemala vs. placebo and an early learning environment vs. no early learning environment on
      the growth, health, and development of young children in Guatemala.
    

Detailed description: 
      The plan is to implement a clustered randomized placebo controlled trial with an infant phase
      (6-12 months of age) and a preschool phase (36-48 months of age). For the infant phase, the
      investigators will use ProPAN (Process for the Promotion of Child Feeding) in the development
      of the evaluation and intervention, with modifications as necessary for the Guatemalan
      context. ProPAN is a tool developed and distributed by the Pan American Health Organization
      to develop, implement, and evaluate interventions and programs to improve infant and young
      child diet and feeding. ProPAN includes four modules:

      Module 1: Assessment Module 2: Testing Recipes and Recommendations Module 3: Intervention
      Module 4: Monitoring and Evaluation

      For the preschool phase, the investigators will use an evidence-based school readiness
      intervention (Little By Little) that has been shown to be effective with Hispanic
      preschoolers. The intervention will be implemented through the Association for the Prevention
      and Study of HIV/AIDS who will train and supervise the community health workers. By working
      directly with a local non-profit organization, the project will be well positioned to inform
      strategies to scale up the intervention on a community wide basis, if beneficial effects are
      shown.

      The project examines the effects of an integrated intervention that includes both
      micronutrient powder added to food and responsive feeding for infants or school readiness for
      preschoolers. The primary aim is to examine how an integrated micronutrients + responsive
      feeding/school readiness intervention changes the development (primary outcome), growth and
      micronutrient status (secondary outcomes) of young children. The investigators will focus on
      infants (6-12 months) when the risk for micronutrient deficiencies is high, as they
      transition from breast feeding to complementary feeding and the family diet. The
      investigators will focus on preschoolers (36-48 months) to examine if micronutrients + a
      school readiness intervention can improve children's school readiness skills. The design
      includes neighborhood clusters randomized into four groups: 1) micronutrients plus responsive
      feeding/school readiness 2) micronutrients only, 3) placebo plus responsive feeding/school
      readiness, and 4) placebo only.

      The investigators will test the following hypotheses:

        1. Children in the two micronutrients groups have better change from baseline in
           development (primary outcome), growth and micronutrient status (secondary oitcomes),
           than children in the two placebo groups.

        2. Mothers and children in the two responsive feeding/school readiness groups have better
           change from baseline measures of child development than those in the two control groups.

        3. The impact of the responsive feeding/school readiness intervention is greater in the
           micronutrient groups than in the placebo groups. Children in the micronutrients plus
           responsive feeding/school readiness group have better change from baseline in
           development than children in any of the other three groups.
    

Intervention name(s): Micronutrients; Responsive feeding; Placebo
Intervention type(s): Dietary Supplement; Behavioral; Dietary Supplement
Intervention description(s): Nutrient Quantity Nutrient Quantity Zinc 9 mg Copper 0.3 mg Iron 12.5 mg Vitamin D3 5 mg Folic Acid 160 mcg Vitamin E 5 mg Iodine 90 mcg Calcium 200 mg Vitamin A 250 mg Phosphorus 150 mg Vitamin C 40 mg Magnesium 40 mg Vitamin B12 0.9 mcg Selenium 17 mcg Thiamine 0.5 mg Manganese 0.17 mg Niacin 0.5 mg Biotin 8 mg Riboflavin 6 mg Vitamin B5 1.8 mg Vitamin B6 0.5 mg; Strategy
Mother ensures that feeding area is set up with infant and mother able to see one another.
Mother mirrors the infant's facial expressions to attract the infant's attention.
Mother interprets infant's behavior with a positive voice, "Oh, you like the spinach." Mother extends infant's behavior by saying, "Oh the cereal is all gone" and doing a consistent hand signal Mother models eating, makes positive comments in a nurturing tone. Mother offers finger food or use of utensil; Riboflavin Vitamin B2
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Micronutrient intervention; Responsive feeding intervention; School readiness intervention