NCT03299218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

August 12, 2017

Last Update Submit

March 18, 2020

Conditions

Keywords

Specialized Nutritious Food (SNF)Social and Behaviour change communication (SBCC)Cash-based transfers

Outcome Measures

Primary Outcomes (3)

  • Reduction in stunting

    10% reduction in stunting in children

    18 months

  • SBCC package on the basis of formative research

    SBCC package will be developed on the basis of formative research

    3 months

  • 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 Outcomes (7)

  • Weight gain in kilograms

    18 months

  • Length gain in centimeters

    18 months

  • Impact of the intervention on micronutrient deficiencies

    At 24 months of age

  • Improvement in IYCF practices

    18 months

  • Improved nutrition, hygiene and health related knowledge and practices

    18 months

  • +2 more secondary outcomes

Study Arms (5)

Control

NO INTERVENTION

Receiving current Government of Punjab health services

Cash-based transfers

EXPERIMENTAL

Cash-based transfers only by BISP

Other: Cash

Cash with SBCC

EXPERIMENTAL

Cash-based transfers and Social \& behaviour change communication (SBCC)

Behavioral: Social and behaviour change communication (SBCC)Other: Cash

Cash with SNF (Wawamum)

EXPERIMENTAL

Cash-based transfers and SNF (Wawamum)

Dietary Supplement: SNF (Wawamum)Other: Cash

Cash,SNF (Wawamum) & SBCC

EXPERIMENTAL

Cash-based transfers, SNF (Wawamum) and SBCC

Dietary Supplement: SNF (Wawamum)Behavioral: Social and behaviour change communication (SBCC)Other: Cash

Interventions

SNF (Wawamum)DIETARY_SUPPLEMENT

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.

Cash with SNF (Wawamum)Cash,SNF (Wawamum) & 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.

Cash with SBCCCash,SNF (Wawamum) & SBCC
CashOTHER

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

Cash with SBCCCash with SNF (Wawamum)Cash,SNF (Wawamum) & SBCCCash-based transfers

Eligibility Criteria

Age6 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00 according to the BISP approach for control group;
  • Living in the catchment area of LHW;
  • Willing and able to provide written informed consent for the study.

You may not qualify if:

  • Non BISP households
  • Planning to migrate form the study area in next 18 months
  • Unable to provide written informed consent
  • Children with severe malnutrition and/or chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehsil Rahim Yar Khan

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

Related Publications (3)

  • Onah MN, Khan GN, Kureishy S, Bourdaire J, de Pee S, Garzon C, Ihtesham Y, Akbar N, Soofi SB. The cost-effectiveness of a cash-based transfer, specialised nutritious food, and social and behaviour change communication intervention package to prevent undernutrition among children 6-23 months in Pakistan: A cluster randomised controlled trial. J Glob Health. 2024 Nov 22;14:04186. doi: 10.7189/jogh.14.04186.

  • Soofi SB, Ariff S, Khan GN, Habib A, Kureishy S, Ihtesham Y, Hussain M, Rizvi A, Sajid M, Akbar N, Garzon C, de Pee S, Bhutta ZA. Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial. Am J Clin Nutr. 2022 Feb 9;115(2):492-502. doi: 10.1093/ajcn/nqab341.

  • Khan GN, Kureishy S, Ariff S, Habib MA, Usmani AA, Mubarik A, Hussain M, Akbar N, Rodriguez de Castro P, Garzon AC, de Pee S, Soofi SB. Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 24;9(8):e19001. doi: 10.2196/19001.

MeSH Terms

Conditions

Growth Disorders

Interventions

CASP8 and FADD-Like Apoptosis Regulating Protein

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Death Domain Receptor Signaling Adaptor ProteinsAdaptor Proteins, Signal TransducingIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis Factor Receptor-Associated Peptides and ProteinsApoptosis Regulatory ProteinsCarrier ProteinsProteins

Study Officials

  • Sajid B Soofi, FCPS, MBBS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 12, 2017

First Posted

October 3, 2017

Study Start

May 26, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations