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Philani Home-based Nutrition Intervention Program

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ClinicalTrials.gov Identifier: NCT00995592
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : October 15, 2009
Sponsor:
Collaborator:
Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa
Information provided by:
University of California, Los Angeles

Brief 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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Philani Home-based Nutrition Intervention Program
Study Start Date : November 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. weight-for-age z-score [ Time Frame: one year ]

Secondary Outcome Measures :
  1. weight in kilograms [ Time Frame: one year ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

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