Back to resultsDistrict-based Mainstreaming Nutrition Project in Rural Pakistan (NF Nutrition)
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Enhanced education
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring malnutrition, growth
Eligibility Criteria
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
Sites / Locations
- AKU-Peds Naushero Feroze Site Office
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Routine LHW Advice
Enhanced LHW Advice
Arm Description
Arm receiving routine advice by their local Lady Health Workers (LHWs)
Arm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits.
Outcomes
Primary Outcome Measures
mother pregnancy weight gain in 3rd trimester
mothers Hb level
child's birthweight
Secondary Outcome Measures
young child's growth
dietary diversity of CF
Full Information
NCT ID
NCT00816946
First Posted
January 2, 2009
Last Updated
January 8, 2018
Sponsor
Aga Khan University
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, National Lady Health Workers Programme, Government of Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT00816946
Brief Title
District-based Mainstreaming Nutrition Project in Rural Pakistan
Acronym
NF Nutrition
Official Title
Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, National Lady Health Workers Programme, Government of Pakistan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
malnutrition, growth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
3000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine LHW Advice
Arm Type
No Intervention
Arm Description
Arm receiving routine advice by their local Lady Health Workers (LHWs)
Arm Title
Enhanced LHW Advice
Arm Type
Active Comparator
Arm Description
Arm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced education
Intervention Description
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
Primary Outcome Measure Information:
Title
mother pregnancy weight gain in 3rd trimester
Time Frame
at time of enrollment, 2 weeks before delivery
Title
mothers Hb level
Time Frame
at time of enrollment, 2 weeks before delivery
Title
child's birthweight
Time Frame
at birth
Secondary Outcome Measure Information:
Title
young child's growth
Time Frame
0, 3, 6, 12, 18 mths, at end of study
Title
dietary diversity of CF
Time Frame
6 mths, 9mths, 12mths, 18 mths
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
AKU-Peds Naushero Feroze Site Office
City
Naushero Feroze
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
District-based Mainstreaming Nutrition Project in Rural Pakistan
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