District-based Mainstreaming Nutrition Project in Rural Pakistan (NF Nutrition)

January 8, 2018 updated by: Dr Zulfiqar Ahmed Bhutta, Aga Khan University

Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh

This study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the National Program for Family Planning and Primary Health Care (LHW Program) and evaluating the feasibility of scaling-up as well as the impact on birth outcomes, nutritional status, morbidity patterns and overall survival patterns at the community level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project aims to do the following:

  • To evaluate the operational feasibility of integrating an enhanced health education and nutrition package into the existing curriculum of the National Program for FP/PHC (LHW Program)
  • Impact of the implementation of the full package of evidence-based nutrition interventions on the nutrition status, morbidity patterns and overall survival patterns in the district

Study Type

Interventional

Enrollment (Actual)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Naushero Feroze, Sindh, Pakistan
        • AKU-Peds Naushero Feroze Site Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Live born infants and young children from all registered pregnancies within participating villages and catchment population
  • pregnant women
  • Consent given by at least one of the parents

Exclusion Criteria:

  • Children born with congenital malformations or serious birth injury
  • Suspected non-compliance (mobile and poorly motivated parents).
  • Failure to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine LHW Advice
Arm receiving routine advice by their local Lady Health Workers (LHWs)
Active Comparator: Enhanced LHW Advice
Arm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits.
Behavioral: Enhanced education

Enhanced Nutritional education/counseling to mothers on the following topics:

During Pregnancy: diet during pregnancy; antenatal care; iron tablets; colostrum Postpartum period: difficulties during lactation; diet during lactation; EBF; childhood vaccination; newborn care Complementary Feeding General Health: vitamin A; diarrhea management; iodine; hygiene for health; protection from malaria; ARI & protection against ARI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mother pregnancy weight gain in 3rd trimester
Time Frame: at time of enrollment, 2 weeks before delivery
at time of enrollment, 2 weeks before delivery
mothers Hb level
Time Frame: at time of enrollment, 2 weeks before delivery
at time of enrollment, 2 weeks before delivery
child's birthweight
Time Frame: at birth
at birth

Secondary Outcome Measures

Outcome Measure
Time Frame
young child's growth
Time Frame: 0, 3, 6, 12, 18 mths, at end of study
0, 3, 6, 12, 18 mths, at end of study
dietary diversity of CF
Time Frame: 6 mths, 9mths, 12mths, 18 mths
6 mths, 9mths, 12mths, 18 mths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh
National Lady Health Workers Programme, Government of Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 2, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (Estimate)

January 5, 2009

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 753-Ped/ERC-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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