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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299218
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : March 19, 2020
Sponsor:
Collaborators:
Benazir Income Support Programme (BISP)
Department of Health, Government of Punjab
World Food Programme (WFP)
Information provided by (Responsible Party):
Dr Sajid Bashir Soofi, Aga Khan University

Brief 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.


Condition or disease Intervention/treatment Phase
Stunting Dietary Supplement: SNF (Wawamum) Behavioral: Social and behaviour change communication (SBCC) Other: Cash Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2179 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
  1. Control Group
  2. Cash-based transfers only by BISP
  3. Cash-based transfers and Social & behaviour change communication (SBCC)
  4. Cash-based transfer and SNF
  5. Cash-based transfers, SNF and SBCC
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders

Arm Intervention/treatment
No Intervention: Control
Receiving current Government of Punjab health services
Experimental: Cash-based transfers
Cash-based transfers only by BISP
Other: Cash
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.

Experimental: Cash with SBCC
Cash-based transfers and Social & behaviour change communication (SBCC)
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.

Experimental: Cash with SNF (Wawamum)
Cash-based transfers and SNF (Wawamum)
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.

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

Experimental: Cash,SNF (Wawamum) & SBCC
Cash-based transfers, SNF (Wawamum) and SBCC
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.




Primary Outcome Measures :
  1. Reduction in stunting [ Time Frame: 18 months ]
    10% reduction in stunting in children

  2. SBCC package on the basis of formative research [ Time Frame: 3 months ]
    SBCC package will be developed on the basis of formative research

  3. Cost-effectiveness of intervention packages for prevention of stunting in children [ Time Frame: 18 months ]
    Cost effectiveness analysis will run through the full three years of the program cost


Secondary Outcome Measures :
  1. Weight gain in kilograms [ Time Frame: 18 months ]
    Child weight in kilograms will be measured on monthly basis

  2. Length gain in centimeters [ Time Frame: 18 months ]
    Child length in centimeters will be measured on monthly basis

  3. Impact of the intervention on micronutrient deficiencies [ Time Frame: At 24 months of age ]
    Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis

  4. Improvement in IYCF practices [ Time Frame: 18 months ]
    Improvement in IYCF practices will be measured from monthly follow-up data

  5. Improved nutrition, hygiene and health related knowledge and practices [ Time Frame: 18 months ]
    Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data

  6. Proportion of households with moderate or severe hunger (food insecurity) [ Time Frame: 18 months ]
    Food insecurity will be measured from baseline and endline data

  7. Uptake of health services and interventions [ Time Frame: 18 months ]
    Uptake of health services and interventions will be measured from baseline and endline data



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299218


Locations
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Pakistan
Tehsil Rahim Yar Khan
Rahim Yar Khan, Punjab, Pakistan, 64200
Sponsors and Collaborators
Aga Khan University
Benazir Income Support Programme (BISP)
Department of Health, Government of Punjab
World Food Programme (WFP)
Investigators
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Principal Investigator: Sajid B Soofi, FCPS, MBBS Aga Khan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03299218    
Other Study ID Numbers: CBT Study Rahim Yar Khan
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Sajid Bashir Soofi, Aga Khan University:
Specialized Nutritious Food (SNF)
Social and Behaviour change communication (SBCC)
Cash-based transfers
Additional relevant MeSH terms:
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Growth Disorders
Pathologic Processes