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CompletedNCT00995592Updated Oct 15, 2009

Philani Home-based Nutrition Intervention Program

A Phase 2 interventional study of Philani nutrition intervention program (mentor mothers) in Child Weight, sponsored by University of California, Los Angeles. Completed at 2 sites in South Africa. Open to female participants. Per ClinicalTrials.gov, last updated 2009-10-15.

Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
684
Allocation
Randomized
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Child Weight

Keywords

  • nutrition
  • child weight
  • undernourishment
  • mentor mother
  • South Africa
03

In context

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • no malnourished children under care
  • malnourished children not living in household
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
684 participants (actual)

Study arms

  • 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)

  • 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.

Interventions

  • BehavioralPhilani 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.

06

What researchers measure

Primary outcomes

  1. weight-for-age z-score

    Time frame: one year

Secondary outcomes

  1. weight in kilograms

    Time frame: one year

07

Study locations

2 sites
  • Philani Child Health and Nutrition Project
    Khayelitsha, Cape Town, South Africa
  • Philani Child Health and Nutrition Project, Khayelitsha
    Cape Town, South Africa
08

References and documents

Publications

  • Christodoulou J, Rotheram-Borus MJ, Bradley AK, Tomlinson M. Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa. J Am Acad Child Adolesc Psychiatry. 2019 Dec;58(12):1165-1174. doi: 10.1016/j.jaac.2019.03.016. Epub 2019 Mar 26. PubMed 30926571 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00995592
Lead sponsor
University of California, Los Angeles
Collaborators
Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa
First posted
Oct 15, 2009
Start date
Nov 2002
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Oct 15, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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