- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00816946
District-based Mainstreaming Nutrition Project in Rural Pakistan (NF Nutrition)
Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Naushero Feroze, Sindh, Pakistan
- AKU-Peds Naushero Feroze Site Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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