Philani Home-based Nutrition Intervention Program

This study has been completed.
Sponsor:
Collaborator:
Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00995592
First received: October 14, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Child Weight
Behavioral: Philani nutrition intervention program (mentor mothers)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Philani Home-based Nutrition Intervention Program

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • weight-for-age z-score [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight in kilograms [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 684
Study Start Date: November 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00995592

Locations
South Africa
Philani Child Health and Nutrition Project
Khayelitsha, Cape Town, South Africa
Philani Child Health and Nutrition Project, Khayelitsha
Cape Town, South Africa
Sponsors and Collaborators
University of California, Los Angeles
Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa
  More Information

No publications provided

Responsible Party: Mary Jane Rotheram-Borus, UCLA - Center for Community Health
ClinicalTrials.gov Identifier: NCT00995592     History of Changes
Other Study ID Numbers: Philani - original study
Study First Received: October 14, 2009
Last Updated: October 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
nutrition
child weight
undernourishment
mentor mother
South Africa

ClinicalTrials.gov processed this record on July 31, 2014