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

Not Applicable
Completed
Conditions
Malnutrition
Interventions
Dietary Supplement: Wheat Soya Blend (WSB)
Dietary Supplement: Wawa Mum
Dietary Supplement: Micronutrient Powders (MNP)
Behavioral: Behavior change and preventive health massages
Registration Number
NCT02422953
Lead Sponsor
Aga Khan University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4020
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionBehavior change and preventive health massagesWheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages
InterventionWawa MumWheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages
InterventionWheat Soya Blend (WSB)Wheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages
InterventionMicronutrient Powders (MNP)Wheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages
Primary Outcome Measures
NameTimeMethod
Stunting-reduction in stunted children in intervention group2 Years

To calculate HAZ scores the 2006 WHO growth reference will be used

Secondary Outcome Measures
NameTimeMethod
Pregnancy out come2 Years

Reduction in low birth weight in newborns

Mean hemoglobin concentration in mothers2 Years

Hemocue will be used to measure Hb concentration

Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age2 Years

Hb spot testing will be conducted

Mean change in weight-for-height z-score (WHZ)2 Years

To calculate WHZ scores the 2006 WHO growth reference will be used

Mean change in weight-for-age z-score (WAZ)2 Years

To calculate WAZ scores the 2006 WHO growth reference will be used

Improvement in infant and young child feeding (IYCF) indicators2 Years

Monthly data collection on IYCF practices

Linear growth velocity (HAZ increment/month)2 Years

To calculate HAZ score the 2006 WHO growth reference will be used

Impact on Zinc status in children at 24 months2 Years

The change in Zinc status (µg/dL) in children at 24 months of age

Mean hemoglobin concentration in children 6-59 months of age2 Years

Hemocue will be used to measure Hb concentration

Prevalence of maternal anemia (Hb concentration<12g/dL)2 Years

Hb spot testing will be conducted

Impact on vitamin D status in children at 24 months2 Years

The change in vitamin D status (ng/mL) in children at 24 months of age

Impact on maternal BMI2 Years

The change in BMI z-score weight and height will be combined to report BMI in kg/m\^2

Impact on vitamin A status in children at 24 months2 Years

The change in Vitamin A status (µmol/L) in children at 24 months of age

Impact on Ferritin status in children at 24 months2 Years

The change in Ferritin status (ng/mL) in children at 24 months of age

Trial Locations

Locations (1)

Aga Khan University

🇵🇰

Karachi, Sindh, Pakistan

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