NCT00816946

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2009

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

January 2, 2009

Last Update Submit

January 8, 2018

Conditions

Keywords

malnutritiongrowth

Outcome Measures

Primary Outcomes (3)

  • mother pregnancy weight gain in 3rd trimester

    at time of enrollment, 2 weeks before delivery

  • mothers Hb level

    at time of enrollment, 2 weeks before delivery

  • child's birthweight

    at birth

Secondary Outcomes (2)

  • young child's growth

    0, 3, 6, 12, 18 mths, at end of study

  • dietary diversity of CF

    6 mths, 9mths, 12mths, 18 mths

Study Arms (2)

Routine LHW Advice

NO INTERVENTION

Arm receiving routine advice by their local Lady Health Workers (LHWs)

Enhanced LHW Advice

ACTIVE COMPARATOR

Arm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits.

Behavioral: Enhanced education

Interventions

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

Enhanced LHW Advice

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKU-Peds Naushero Feroze Site Office

Naushero Feroze, Sindh, Pakistan

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Founding Director, Centre of Excellence in Women and Child Health

Study Record Dates

First Submitted

January 2, 2009

First Posted

January 5, 2009

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations