Clinical trial NCT02422953: Stunting Prevention Project in Thatta and Sujawal Districts, Sindh Province, Pakistan
Official title: Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Stunting
Wasting
Underweight
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: United Nations World Food Programme (WFP)
name: Pakistan Ministry of Health
First posted: 2015-04-22
Enrollment: 4020
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Stunting-reduction in stunted children in intervention group
timeFrame: 2 Years
Secondary outcomes:
measure: Pregnancy out come
timeFrame: 2 Years
measure: Mean change in weight-for-height z-score (WHZ)
timeFrame: 2 Years
measure: Mean change in weight-for-age z-score (WAZ)
timeFrame: 2 Years
measure: Improvement in infant and young child feeding (IYCF) indicators
timeFrame: 2 Years
measure: Linear growth velocity (HAZ increment/month)
timeFrame: 2 Years
measure: Mean hemoglobin concentration in children 6-59 months of age
timeFrame: 2 Years
measure: Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age
timeFrame: 2 Years
measure: Mean hemoglobin concentration in mothers
timeFrame: 2 Years
measure: Prevalence of maternal anemia (Hb concentration<12g/dL)
timeFrame: 2 Years
measure: Impact on maternal BMI
timeFrame: 2 Years
measure: Impact on vitamin A status in children at 24 months
timeFrame: 2 Years
measure: Impact on vitamin D status in children at 24 months
timeFrame: 2 Years
measure: Impact on Zinc status in children at 24 months
timeFrame: 2 Years
measure: Impact on Ferritin status in children at 24 months
timeFrame: 2 Years
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Sajid B Soofi, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Nutrition Survey (NNS), 2011. Planning Commission Planning and Development Division Government of Pakistan.
citation: WFP (2012): Protracted Relief and Recovery Operations (PRRO). Pakistan 200250. Rome, Italy.
citation: Horton, S. Opportunities for investments in nutrition in low-income Asia; 1999. Asian Development Review 17 (1, 2): 246-273.
citation: 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.
citation: Donner, A. and Klar, N. Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London; 2000
citation: Khan GN, Kureishy S, Ariff S, Rizvi A, Sajid M, Garzon C, Khan AA, de Pee S, Soofi SB, Bhutta ZA. Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial. PLoS One. 2020 Aug 13;15(8):e0237210. doi: 10.1371/journal.pone.0237210. eCollection 2020.
citation: Zaidi S, Das JK, Khan GN, Najmi R, Shah MM, Soofi SB. Food supplements to reduce stunting in Pakistan: a process evaluation of community dynamics shaping uptake. BMC Public Health. 2020 Jul 2;20(1):1046. doi: 10.1186/s12889-020-09103-8.
citation: Kureishy S, Khan GN, Arrif S, Ashraf K, Cespedes A, Habib MA, Hussain I, Ullah A, Turab A, Ahmed I, Zaidi S, Soofi SB. A mixed methods study to assess the effectiveness of food-based interventions to prevent stunting among children under-five years in Districts Thatta and Sujawal, Sindh Province, Pakistan: study protocol. BMC Public Health. 2017 Jan 5;17(1):24. doi: 10.1186/s12889-016-3976-y.