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Clinical Trials/NCT02422953
NCT02422953
Completed
Not Applicable

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

Aga Khan University1 site in 1 country4,020 target enrollmentAugust 2014
ConditionsMalnutrition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Aga Khan University
Enrollment
4020
Locations
1
Primary Endpoint
Stunting-reduction in stunted children in intervention group
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
September 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Sajid Bashir Soofi

Associate Professor

Aga Khan University

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

Outcomes

Primary Outcomes

Stunting-reduction in stunted children in intervention group

Time Frame: 2 Years

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

Secondary Outcomes

  • Mean hemoglobin concentration in mothers(2 Years)
  • Linear growth velocity (HAZ increment/month)(2 Years)
  • Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age(2 Years)
  • Mean change in weight-for-height z-score (WHZ)(2 Years)
  • Mean change in weight-for-age z-score (WAZ)(2 Years)
  • Improvement in infant and young child feeding (IYCF) indicators(2 Years)
  • Impact on Zinc status in children at 24 months(2 Years)
  • Mean hemoglobin concentration in children 6-59 months of age(2 Years)
  • Pregnancy out come(2 Years)
  • Prevalence of maternal anemia (Hb concentration<12g/dL)(2 Years)
  • Impact on vitamin D status in children at 24 months(2 Years)
  • Impact on maternal BMI(2 Years)
  • Impact on vitamin A status in children at 24 months(2 Years)
  • Impact on Ferritin status in children at 24 months(2 Years)

Study Sites (1)

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