Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan

Stunting Clinical Trial

Official title:

Effectiveness of a Programme Comprised of SNF, Cash-based Transfers and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Punjab, Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299218
• Other study ID #: CBT Study Rahim Yar Khan
• Status: Completed
• Phase: N/A
• Start date: May 26, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.

Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.

Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food Program (WFP) Pakistan is proposing an intervention program comprised of cash-based transfers, specialized nutritious foods and behaviours change communication to prevent stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered through the existing health system and Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health, Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process and outcome indicators.

Description:

Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.

The second Lancet Series on Maternal and Child Under-nutrition (2013) and the Scaling-Up Nutrition (SUN) Initiative give some recommendations on selected effective approaches for the management and prevention of under-nutrition, such as breastfeeding counselling or micronutrient supplementation, but evidence gaps still remain, particularly concerning indirect interventions. The World Health Organization highlighted in 2010 the need to consider prevention strategies when implementing programs aiming at reducing stunting rates. There is also evidence showing that preventive programs, such as supplementation, can be more effective to reduce childhood under-nutrition than nutrition rehabilitation. Reviews on cash transfer experiences show that this type of intervention has the potential to prevent undernutrition. However, most of the cash transfer programs implemented and scientifically evaluated do not have a clear nutritional objective, which leads to inconclusive evidence regarding their nutritional benefits.

Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are especially evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.

Given the alarming situation of child malnutrition in Rahim Yar Khan district, the World Food Programme (WFP) Pakistan is proposing an intervention programme comprised of cash-based transfers, specialized nutritious foods and behavior change communication to prevent stunting in Rahim Yar Khan district, Punjab province. The interventions will be delivered through the existing health system and the social protection programme, Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. The study will be conducted by the Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan. This document will describe the methods and strategies that AKU will employ to assess the effectiveness of the interventions on process and outcome indicators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2179
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 7 Months

Eligibility

Inclusion Criteria:

1. BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00 according to the BISP approach for control group;

2. Living in the catchment area of LHW;

3. Have at least one child of 6-7 months old at the time of inclusion, and;

4. Willing and able to provide written informed consent for the study.

Exclusion Criteria:

1. Non BISP households

2. Planning to migrate form the study area in next 18 months

3. Unable to provide written informed consent

4. Children with severe malnutrition and/or chronic illness

Related Conditions & MeSH terms

• Growth Disorders
• Stunting

Intervention

Dietary Supplement:
• SNF (Wawamum)
A monthly ration of 30 sachets of SNF (one 50 gram sachet of Wawamum per child per day) will be provided by LHWs. Each recruited child will receive SNF on a monthly basis for the duration of 18 months during his/her age of 6-24 months.

Behavioral:
• Social and behaviour change communication (SBCC)
SBCC messages will be delivered by LHWs in their monthly routine household visits. Male and female group sessions will be arranged on quarterly basis with the help of health committees.

Other:
• Cash
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.

Locations

Country	Name	City	State
Pakistan	Tehsil Rahim Yar Khan	Rahim Yar Khan	Punjab

Sponsors (4)

Lead Sponsor	Collaborator
Aga Khan University	Benazir Income Support Programme (BISP), Department of Health, Government of Punjab, World Food Programme (WFP)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in stunting	10% reduction in stunting in children	18 months
Primary	SBCC package on the basis of formative research	SBCC package will be developed on the basis of formative research	3 months
Primary	Cost-effectiveness of intervention packages for prevention of stunting in children	Cost effectiveness analysis will run through the full three years of the program cost	18 months
Secondary	Weight gain in kilograms	Child weight in kilograms will be measured on monthly basis	18 months
Secondary	Length gain in centimeters	Child length in centimeters will be measured on monthly basis	18 months
Secondary	Impact of the intervention on micronutrient deficiencies	Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis	At 24 months of age
Secondary	Improvement in IYCF practices	Improvement in IYCF practices will be measured from monthly follow-up data	18 months
Secondary	Improved nutrition, hygiene and health related knowledge and practices	Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data	18 months
Secondary	Proportion of households with moderate or severe hunger (food insecurity)	Food insecurity will be measured from baseline and endline data	18 months
Secondary	Uptake of health services and interventions	Uptake of health services and interventions will be measured from baseline and endline data	18 months