MalnutritionLUCOMAINCT01977365
Effectiveness of Child Centered Counseling on Child Nutrition Status
A study testing Growth promotion based on child centered approach in people with Malnutrition, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
Trial summary
Hypothesis N°1: The "children growth promotion based on approach centered on their specific needs" enhances caretakers and health workers skills, knowledge and practices on breastfeeding, complementary feeding and child care. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Growth promotion based on child centered approach
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,341 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Feb 2009to Mar 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
-Inclusion Criteria: all women of childbearing age in the third trimester of pregnancy, living in the study area for at least one year at the time of the inclusion and who gave informed consent.
Exclusion Criteria:
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut de Recherche en Sciences de la Santé
Ouagadougou, Kadiogo, 06 BP 7192
About this study
Official title: Effectiveness of Child Centered Counseling on Child Nutrition Status. A Cluster Randomized Trial in Rural Burkina Faso.
Hypothesis N°1: The "children growth promotion based on approach centered on their specific needs" enhances caretakers and health workers skills, knowledge and practices on breastfeeding, complementary feeding and child care.
Hypothesis N°1: children growth promotion based on approach centered on their specific needs" approach improves children growth and health.
- Conditions
- Malnutrition
- Being tested
- Growth promotion based on child centered approach
- Keywords
- Cluster Randomized Trial,, Nutrition counseling,, Caretaker's knowledge, Child growth,, Prevention,, Acute malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth promotion based on child centered approachBehavioural
- Preventive consultations will be reorganized. From the child birth, a follow-up schedule will be establish in agreement with the mother, and the subsequent appointment will be renew at each meeting.
Ten contacts will be organized for children under two years. During the first year, the number of contacts will be limited to 6 at birth , 2 , 3, 4 and 9 months to complete the vaccination schedule and an additional contact at 7 months to allow monitoring during the introduction of complementary foods.
Four contacts will be held for the second year to 12, 15, 18 and 24 months to monitor the transition from complementary food to the family diet.
- Inclusion of Child Centered growth promotion approach. During preventive consultations, specific messages according to the child age, health and nutritional status will be developed, based on scientific evidences and adapted to the experience and knowledge of health workers.
| Study group | Role | What they receive |
|---|---|---|
| Growth promotion based on child centered approach | Experimental | Not described Receives: Behavioral: Growth promotion based on child centered approach |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute malnutrition
Measured: 18 months
Secondary outcomes (1)
Incidence of Diarrhea, fever, Acute respiratory infection
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startFeb 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Sponsor type
- Other government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Principal investigator, Laetitia Ouedraogo, Institut de Recherche en Sciences de la Sante, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977365
- Sponsor's protocol ID
- IRSSOOO1
- Acronym
- LUCOMAI
- Status last verified
- Oct 2013
- First submitted
- 30 Oct 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Child Centered Counseling on Child Nutrition Status. A Cluster Randomized Trial in Rural Burkina Faso.
- ClinicalTrials.gov ID
- NCT01977365
- Acronym / sponsor ID
- LUCOMAI / IRSSOOO1
- Conditions
- Malnutrition
- Keywords
- Cluster Randomized Trial,, Nutrition counseling,, Caretaker's knowledge, Child growth,, Prevention,, Acute malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,341 participants (actual)
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina FasoOther government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- Feb 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Nov 2013 (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.
Hypothesis N°1: The "children growth promotion based on approach centered on their specific needs" enhances caretakers and health workers skills, knowledge and practices on breastfeeding, complementary feeding and child care.
Hypothesis N°1: children growth promotion based on approach centered on their specific needs" approach improves children growth and health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth promotion based on child centered approach | Experimental | Behavioral: Growth promotion based on child centered approach |
| Control | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Growth promotion based on child centered approach- Preventive consultations will be reorganized. From the child birth, a follow-up schedule will be establish in agreement with the mother, and the subsequent appointment will be renew at each meeting. Ten contacts will be organized for children under two years. During the first year, the number of contacts will be limited to 6 at birth , 2 , 3, 4 and 9 months to complete the vaccination schedule and an additional contact at 7 months to allow monitoring during the introduction of complementary foods. Four contacts will be held for the second year to 12, 15, 18 and 24 months to monitor the transition from complementary food to the family diet. - Inclusion of Child Centered growth promotion approach. During preventive consultations, specific messages according to the child age, health and nutritional status will be developed, based on scientific evidences and adapted to the experience and knowledge of health workers. | Behavioural | Growth promotion based on child centered approach |
Primary outcome
Incidence of acute malnutrition
Time frame: 18 months
1 secondary outcome
Incidence of Diarrhea, fever, Acute respiratory infection
Time frame: 18 months
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 6 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth promotion based on child centered approach in people with Malnutrition, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. 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.
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?
Incidence of acute malnutrition (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2013.