CClinicalTrials.gg
CompletedNCT00816946NF NutritionUpdated Jan 9, 2018

District-based Mainstreaming Nutrition Project in Rural Pakistan

An interventional study of Enhanced education in Malnutrition, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Non-randomized
Sex
All
01

Study summary

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.

Read the 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
02

Conditions studied

  • Malnutrition

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Keywords

  • malnutrition
  • growth
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 3,000 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Children born with congenital malformations or serious birth injury
  • Suspected non-compliance (mobile and poorly motivated parents).
  • Failure to give consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
3,000 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralEnhanced 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

06

What researchers measure

Primary outcomes

  1. mother pregnancy weight gain in 3rd trimester

    Time frame: at time of enrollment, 2 weeks before delivery

  2. mothers Hb level

    Time frame: at time of enrollment, 2 weeks before delivery

  3. child's birthweight

    Time frame: at birth

Secondary outcomes

  1. young child's growth

    Time frame: 0, 3, 6, 12, 18 mths, at end of study

  2. dietary diversity of CF

    Time frame: 6 mths, 9mths, 12mths, 18 mths

07

Study locations

1 site
  • AKU-Peds Naushero Feroze Site Office
    Naushero Feroze, Sindh, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00816946
Lead sponsor
Aga Khan University
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, National Lady Health Workers Programme, Government of Pakistan
Responsible party
Dr Zulfiqar Ahmed Bhutta (Professor and Founding Director, Centre of Excellence in Women and Child Health, Aga Khan University) — Principal investigator
First posted
Jan 5, 2009
Start date
Jul 2008
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Jan 9, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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