Philani Home-based Nutrition Intervention Program

October 14, 2009 updated by: University of California, Los Angeles

Malnourished children and babies with birth weights under 2500 grams are at high risk for negative outcomes over their lifespan. Philani, a paraprofessional home-visiting program, was mounted in neighborhoods in three townships in Cape Town, South Africa, from 2002 to 2004 to improve nutritional outcomes.

One mentor mother was recruited from each of 37 neighborhoods. Mentor mothers were trained to conduct home visits to weigh children and to support mothers to problem-solve life challenges, especially around nutrition. Households were randomly assigned on a 2-to-1 ratio to the Philani program or to a standard care condition. Children were evaluated over a 1-year period.

The investigators hypothesized that children in the intervention would gain more weight than children in the control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

684

Phase

  • Phase 2

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

  • South Africa
      • Cape Town, South Africa
        • Philani Child Health and Nutrition Project, Khayelitsha
    • Cape Town
      • Khayelitsha, Cape Town, South Africa
        • Philani Child Health and Nutrition Project

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • mother or caregiver
  • with child under 5 years of age and malnourished (malnourished if less than 2 standard deviations below the World Health Organization normative mean weight for the child's age

Exclusion Criteria:

  • no malnourished children under care
  • malnourished children not living in household

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mentor mothers
Behavioral intervention was offered through mentor mothers. Mentors were mothers in community who were selected by because they were doing well. They were trained to conduct home visits, up to 16 times over one year period, ranging from 20 minutes to 2 hours. Mentor mothers worked to improve health of mother and their child and build social support in neighborhood.
Behavioral: Philani nutrition intervention program (mentor mothers)
Behavioral intervention was offered through mentor mothers. Mentors were mothers in community who were selected by because they were doing well. They were trained to conduct home visits, up to 16 times over one year period, ranging from 20 minutes to 2 hours. Mentor mothers worked to improve health of mother and their child and build social support in neighborhood.
No Intervention: Control
Control cases were visited and their infants were weighed 4 times over one year period. After one year, mothers were provided Philani nutrition intervention program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight-for-age z-score
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
weight in kilograms
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Collaborators

Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Estimate)

October 15, 2009

Last Update Submitted That Met QC Criteria

October 14, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Philani - original study

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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