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Completed

NCT Number: NCT00995592

Philani Home-based Nutrition Intervention Program

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.

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Key information

Conditions

Child Weight

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Philani nutrition intervention program (mentor mothers)

Behavioral

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.

Primary outcomes

  1. weight-for-age z-score

    Time frame: one year

Secondary outcomes

  1. weight in kilograms

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

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

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Oct 15, 2009
Registry last updated
Oct 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.