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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422953
• Other study ID #: WFP-Thatta
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2019
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4020
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Growth Disorders
• Malnutrition

Intervention

Dietary Supplement:
• Wheat Soya Blend (WSB)
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
• Wawa Mum
Children 6-23 months of age will receive a daily ration of 50 gram of Wawa Mum during study period
• Micronutrient Powders (MNP)
Children 24-59 months of age will receive a sachet of Micronutrient Powders (MNP) in alternate days

Behavioral:
• Behavior change and preventive health massages
Behavior change and preventive health massages will be delivered by lady health workers (LHWs) during monthly visits and in group meetings

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Pakistan Ministry of Health, United Nations World Food Programme (WFP)

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Donner, A. and Klar, N. Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London; 2000

Gorstein J, Sullivan KM, Parvanta I, Begin F. Indicators and Methods for Cross-Sectional Surveys of Vitamin and Mineral Status of Populations. The Micronutrient Initiative (Ottawa) and the Centers for Disease Control and Prevention (Atlanta), May 2007.

Horton, S. Opportunities for investments in nutrition in low-income Asia; 1999. Asian Development Review 17 (1, 2): 246-273.

National Nutrition Survey (NNS), 2011. Planning Commission Planning and Development Division Government of Pakistan.

WFP (2012): Protracted Relief and Recovery Operations (PRRO). Pakistan 200250. Rome, Italy.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stunting-reduction in stunted children in intervention group	To calculate HAZ scores the 2006 WHO growth reference will be used	2 Years
Secondary	Pregnancy out come	Reduction in low birth weight in newborns	2 Years
Secondary	Mean change in weight-for-height z-score (WHZ)	To calculate WHZ scores the 2006 WHO growth reference will be used	2 Years
Secondary	Mean change in weight-for-age z-score (WAZ)	To calculate WAZ scores the 2006 WHO growth reference will be used	2 Years
Secondary	Improvement in infant and young child feeding (IYCF) indicators	Monthly data collection on IYCF practices	2 Years
Secondary	Linear growth velocity (HAZ increment/month)	To calculate HAZ score the 2006 WHO growth reference will be used	2 Years
Secondary	Mean hemoglobin concentration in children 6-59 months of age	Hemocue will be used to measure Hb concentration	2 Years
Secondary	Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age	Hb spot testing will be conducted	2 Years
Secondary	Mean hemoglobin concentration in mothers	Hemocue will be used to measure Hb concentration	2 Years
Secondary	Prevalence of maternal anemia (Hb concentration<12g/dL)	Hb spot testing will be conducted	2 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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