Stunting Prevention Project in Thatta and Sujawal Districts, Sindh Province, Pakistan

Study Overview
=================
Brief Summary
-----------------
Widespread food insecurity and malnutrition are largely the main impairing factors for human capital development in Pakistan. Rates of chronic malnutrition are very high, and acute malnutrition is critical: 44% of children under five are stunted and nationwide global acute malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of 15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting rates were at 36%. This study evaluates the effectiveness of food based interventions to prevent stunting among children under-five years with focus on window of opportunity (1000 days from conception to 2 years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months will receive supplements on monthly basis in intervention areas, while participants in control areas will receive routine public health services available in the study area.

Detailed Description
-----------------
Children under two are consuming less than half of their daily energy requirements (560 kcal) and lower than recommended levels of micronutrients (one-third of reference nutrient intake for Iron and one-half for Zinc). Overall, less than 4% of children were receiving an acceptable, diverse diet. Food security and nutrition situation in Sindh province is even more dramatic. According to the National Nutrition Survey, 2011, GAM prevalence exceeds 18% while anemia levels amongst children under five reached the alarming level of 72.5%. With this high level of poverty and food insecurity, a food based approach to prevent stunting, together with non- food based approaches is needed. Therefore, Division of Women and Child Health, Aga Khan University proposes a research study for stronger evidence base on the effectiveness of preventive food/nutrient based interventions on reduction of stunting and developing viable programmes on nutrition under real operational conditions. The effectiveness of the project will be measured in terms of the impact of the proposed interventions on the stunting and micronutrient deficiency prevalences in the target group (children and mothers). Given the conditions of project implementation, a quasi-experimental double difference design would be appropriate to assess the impact of the intervention. We propose to compare the intervention and non-intervention (control) groups before (first difference) and after the intervention (second difference). Then, the operational implementation of the research comprises a baseline and end line surveys. In addition, a nested cluster randomized controlled trial will be implemented to track the evolution of key variables related to the quality of intervention delivery and intermediate nutrition outcomes. The control clusters will receive routine public and private health services available in the area. To achieve its purpose and objectives the project design includes core interventions such as complementary feeding using food/nutrient based supplements along with behavior change communication, complemented with other non-food interventions. Using a preventative (blanket) approach, three types of food/nutrient supplements (Wawamum, MNP & WSB) are considered as part of the interventions.

Official Title
-----------------
Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Wheat Soya Blend (WSB)
* Dietary Supplement: Wawa Mum
* Dietary Supplement: Micronutrient Powders (MNP)
* Behavioral: Behavior change and preventive health massages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women All lactating mothers (upto 6 months) All children 6-23 months of age All children 24-59 months of age Exclusion Criteria: Refuse to participate in the study Having severe chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Wheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages | Dietary Supplement: Wheat Soya Blend (WSB)<br>* A monthly ration of 5 Kg of Wheat Soya Blend (WSB) will be given to pregnant women every month during pregnancy and lactating mothers for six months after giving birth<br>Dietary Supplement: Wawa Mum<br>* Children 6-23 months of age will receive a daily ration of 50 gram of Wawa Mum during study period<br>Dietary Supplement: Micronutrient Powders (MNP)<br>* Children 24-59 months of age will receive a sachet of Micronutrient Powders (MNP) in alternate days<br>Behavioral: Behavior change and preventive health massages<br>* Behavior change and preventive health massages will be delivered by lady health workers (LHWs) during monthly visits and in group meetings<br>|
| No Intervention: Control<br>Control group will receive routine public and private health services available in the area. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stunting-reduction in stunted children in intervention group | To calculate HAZ scores the 2006 WHO growth reference will be used | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy out come | Reduction in low birth weight in newborns | 2 Years | 
| Mean change in weight-for-height z-score (WHZ) | To calculate WHZ scores the 2006 WHO growth reference will be used | 2 Years | 
| Mean change in weight-for-age z-score (WAZ) | To calculate WAZ scores the 2006 WHO growth reference will be used | 2 Years | 
| Improvement in infant and young child feeding (IYCF) indicators | Monthly data collection on IYCF practices | 2 Years | 
| Linear growth velocity (HAZ increment/month) | To calculate HAZ score the 2006 WHO growth reference will be used | 2 Years | 
| Mean hemoglobin concentration in children 6-59 months of age | Hemocue will be used to measure Hb concentration | 2 Years | 
| Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age | Hb spot testing will be conducted | 2 Years | 
| Mean hemoglobin concentration in mothers | Hemocue will be used to measure Hb concentration | 2 Years | 
| Prevalence of maternal anemia (Hb concentration<12g/dL) | Hb spot testing will be conducted | 2 Years | 
| Impact on maternal BMI | The change in BMI z-score weight and height will be combined to report BMI in kg/m^2 | 2 Years | 
| Impact on vitamin A status in children at 24 months | The change in Vitamin A status (µmol/L) in children at 24 months of age | 2 Years | 
| Impact on vitamin D status in children at 24 months | The change in vitamin D status (ng/mL) in children at 24 months of age | 2 Years | 
| Impact on Zinc status in children at 24 months | The change in Zinc status (µg/dL) in children at 24 months of age | 2 Years | 
| Impact on Ferritin status in children at 24 months | The change in Ferritin status (ng/mL) in children at 24 months of age | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stunting, Wasting, Underweight