Child WeightPhase 2NCT00995592
Philani Home-based Nutrition Intervention Program
A Phase 2 study testing Philani nutrition intervention program (mentor mothers) in people with Child Weight, run by University of California, Los Angeles at 2 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Child Weight
- What is being tested?
- Philani nutrition intervention program (mentor mothers)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Nov 2002to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no malnourished children under care
- malnourished children not living in household
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Philani Child Health and Nutrition Project, Khayelitsha
Cape Town
Philani Child Health and Nutrition Project
Khayelitsha, Cape Town
About this study
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.
- Conditions
- Child Weight
- Being tested
- Philani nutrition intervention program (mentor mothers)
- Keywords
- nutrition, child weight, undernourishment, mentor mother, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philani nutrition intervention program (mentor mothers)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mentor mothers | Experimental | 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. Receives: Behavioral: Philani nutrition intervention program (mentor mothers) |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
weight-for-age z-score
Measured: one year
Secondary outcomes (1)
weight in kilograms
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startNov 2002
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child WeightStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995592
- Sponsor's protocol ID
- Philani - original study
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 15 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philani Home-based Nutrition Intervention Program
- ClinicalTrials.gov ID
- NCT00995592
- Acronym / sponsor ID
- Philani - original study
- Conditions
- Child Weight
- Keywords
- nutrition, child weight, undernourishment, mentor mother, South Africa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa
- Study start
- Nov 2002
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentor mothers | Experimental | 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. |
| Control | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- no malnourished children under care
- malnourished children not living in household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mentor mothers |
Primary outcome
weight-for-age z-score
Time frame: one year
1 secondary outcome
weight in kilograms
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
- Derived from this study: PubMed 30926571Christodoulou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Philani nutrition intervention program (mentor mothers) in people with Child Weight, run by University of California, Los Angeles at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight-for-age z-score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.