MalnutritionNCT00210418
Effectiveness of Targeting Food Aid to Malnourished Children Compared to Targeting All Children Under Two Years
A study testing Fortified food rations and Education and communication to improve feeding practices in people with Malnutrition, run by International Food Policy Research Institute at 1 site in Haiti.
Trial summary
The objective of this study is to compare two approaches to targeting donated supplementary food to young children. The study compares the effectiveness of the widely-used curative approach where targeting is based on the child's poor nutritional status to a preventive approach which targets children in poor… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Fortified food rations and Education and communication to improve feeding practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteHaiti
- Study dates
- May 2002to Sep 2005
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Family resides in community served by World-Vision Haiti's Maternal and Child Health and Nutrition Program
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention or Cure: A Comparison of the Effectiveness of Targeting Food Supplements to Malnourished Children Compared to Universal Targeting of Children Under Two in Haiti
The objective of this study is to compare two approaches to targeting donated supplementary food to young children. The study compares the effectiveness of the widely-used curative approach where targeting is based on the child's poor nutritional status to a preventive approach which targets children in poor communities solely on the basis of age and provides supplementary food to all children aged 6-23 months. Cost-effectiveness of the two targeting approaches will also be assessed.
Read the detailed description
Under-nutrition is widespread among young children in poor countries. In many countries one of the programmatic responses has been distribution of supplementary food to under-nourished children and, often, their families. Traditionally, children under five years have been identified based on low weight-for-age or other anthropometric indicators, and those below a certain cut-off have received supplements. Typically this results in supplementation of many children in the 3-5 year age range, since they are most likely to display cumulative deficits in height and weight, and thus fall below the chosen cut-off.
However, there has been increasing evidence that the most effective period to ensure benefit from supplementary food is when children are 6 to 24 months of age. This is the period of highest growth velocity among humans and thus a period when most growth faltering occurs.
Based on this evidence, the current study aims to assess the effectiveness and cost-effectiveness of a preventive approach that targets children under 24 months as compared to the traditional "curative" approach that targets malnourished (and usually older) children under the age of 5 years.
The comparison is made in the programmatic context of a US Title II food aid distribution program implemented by an international non-governmental organization in rural Haiti. This programmatic context is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study has also involved development of new nutrition education materials and tools, aimed at enabling caregivers to prevent malnutrition. In addition, a range of program operational issues will be studied in order to yield results useful to other implementers of similar interventions.
Comparison: Comparisons will be made at the level of the program site, with service delivery points randomized either to target food supplements as in the past, based on the child's nutritional status, or to target preventively based on age. Pregnant women and lactating women with infants under 6 months of age will receive supplements under both targeting models. Effectiveness will be assessed based on two cross-sectional surveys, at baseline and two years after full implementation of the program.
- Conditions
- Malnutrition
- Being tested
- Fortified food rations, Education and communication to improve feeding practices
- Keywords
- Malnutrition, Infant nutrition, Food, fortified, Growth, Randomized controlled trials, Evaluation studies, Haiti
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified food rationsDietary supplement
The Fortified food rations were included in both arms, but targeted to all children 6-24 months of age in the 'preventive' arm and to malnourished children (WAZ <-2 Z-scores) in the 'recuperative arm. Food rations included Corn-Soy Blend, lentils, oil and wheat.
Education and communication to improve feeding practicesBehavioural
The education and communication to improve infant and young child feeding was an integral part of the intervention. In the preventive arm, this intervention was targeted to pregnant and lactating mothers and mothers of children 0-24 months of age. The education was done using mother's groups In the recuperative arm, the BCC intervention was only targeted to pregnant and lactating women and mothers of malnourished children under the age of five.
| Study group | Role | What they receive |
|---|---|---|
| Preventive targeting | Experimental | This arm targeted pregnant and lactating women as well as children 6-23.9 months of age to receive BCC and food assistance. A total of 27 months of enrollment in this program arm was possible. Receives: Dietary Supplement: Fortified food rations; Behavioral: Education and communication to improve feeding practices |
| Recuperative targeting | Active comparator | This arm targeted pregnant and lactating women as well as mothers of malnourished children (WAZ <-2 zscores) between 6 and 59 months of age. A total of 18 months of enrollment was possible in this program arm. Receives: Dietary Supplement: Fortified food rations; Behavioral: Education and communication to improve feeding practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean z-scores (height-for-age, weight-for-age, weight-for-height) two years after intervention implemented
Prevalence of undernutrition (stunting, wasting, underweight) two years after implementation of intervention
Secondary outcomes (2)
Maternal knowledge about child feeding practices recommended through behavioral intervention at 2 years after implementation of intervention;
Feeding practices and other caregiving practices at 2 years after implementation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Food and Nutrition Technical Assistance Project, United States Agency for International Development (USAID), World Vision, Government of Germany, United Nations World Food Programme (WFP)
- Investigators
- Marie T. Ruel, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210418
- Sponsor's protocol ID
- 212620-0S-IFPRI
- Other IDs
- 81051898
- Status last verified
- Aug 2012
- First submitted
- 13 Sep 2005
- Last updated
- 30 Aug 2012
- Results posted
- No
Publications
Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
PubMed 15646314Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95. doi: 10.1016/S0140-6736(08)60271-8.
PubMed 18280329Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. doi: 10.1177/156482650502600210. No abstract available.
PubMed 16060227Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7. doi: 10.1093/jn/138.3.634.
PubMed 18287379Donegan S, Maluccio JA, Myers CK, Menon P, Ruel MT, Habicht JP. Two food-assisted maternal and child health nutrition programs helped mitigate the impact of economic hardship on child stunting in Haiti. J Nutr. 2010 Jun;140(6):1139-45. doi: 10.3945/jn.109.114272. Epub 2010 Apr 14.
PubMed 20392883
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention or Cure: A Comparison of the Effectiveness of Targeting Food Supplements to Malnourished Children Compared to Universal Targeting of Children Under Two in Haiti
- ClinicalTrials.gov ID
- NCT00210418
- Acronym / sponsor ID
- 212620-0S-IFPRI
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Infant nutrition, Food, fortified, Growth, Randomized controlled trials, Evaluation studies, Haiti
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Cornell University, Food and Nutrition Technical Assistance Project, United States Agency for International Development (USAID), World Vision, Government of Germany, United Nations World Food Programme (WFP)
- Study start
- May 2002
- Study completion
- Sep 2005 (actual)
- First posted
- 21 Sep 2005 (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.
The objective of this study is to compare two approaches to targeting donated supplementary food to young children. The study compares the effectiveness of the widely-used curative approach where targeting is based on the child's poor nutritional status to a preventive approach which targets children in poor communities solely on the basis of age and provides supplementary food to all children aged 6-23 months. Cost-effectiveness of the two targeting approaches will also be assessed.
Detailed description
Under-nutrition is widespread among young children in poor countries. In many countries one of the programmatic responses has been distribution of supplementary food to under-nourished children and, often, their families. Traditionally, children under five years have been identified based on low weight-for-age or other anthropometric indicators, and those below a certain cut-off have received supplements. Typically this results in supplementation of many children in the 3-5 year age range, since they are most likely to display cumulative deficits in height and weight, and thus fall below the chosen cut-off.
However, there has been increasing evidence that the most effective period to ensure benefit from supplementary food is when children are 6 to 24 months of age. This is the period of highest growth velocity among humans and thus a period when most growth faltering occurs.
Based on this evidence, the current study aims to assess the effectiveness and cost-effectiveness of a preventive approach that targets children under 24 months as compared to the traditional "curative" approach that targets malnourished (and usually older) children under the age of 5 years.
The comparison is made in the programmatic context of a US Title II food aid distribution program implemented by an international non-governmental organization in rural Haiti. This programmatic context is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study has also involved development of new nutrition education materials and tools, aimed at enabling caregivers to prevent malnutrition. In addition, a range of program operational issues will be studied in order to yield results useful to other implementers of similar interventions.
Comparison: Comparisons will be made at the level of the program site, with service delivery points randomized either to target food supplements as in the past, based on the child's nutritional status, or to target preventively based on age. Pregnant women and lactating women with infants under 6 months of age will receive supplements under both targeting models. Effectiveness will be assessed based on two cross-sectional surveys, at baseline and two years after full implementation of the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive targeting | Experimental | Dietary Supplement: Fortified food rations, Behavioral: Education and communication to improve feeding practicesThis arm targeted pregnant and lactating women as well as children 6-23.9 months of age to receive BCC and food assistance. A total of 27 months of enrollment in this program arm was possible. |
| Recuperative targeting | Active comparator | Dietary Supplement: Fortified food rations, Behavioral: Education and communication to improve feeding practicesThis arm targeted pregnant and lactating women as well as mothers of malnourished children (WAZ <-2 zscores) between 6 and 59 months of age. A total of 18 months of enrollment was possible in this program arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Family resides in community served by World-Vision Haiti's Maternal and Child Health and Nutrition Program
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Fortified food rationsThe Fortified food rations were included in both arms, but targeted to all children 6-24 months of age in the 'preventive' arm and to malnourished children (WAZ <-2 Z-scores) in the 'recuperative arm. Food rations included Corn-Soy Blend, lentils, oil and wheat. | Dietary supplement | Preventive targeting, Recuperative targeting |
| Education and communication to improve feeding practicesThe education and communication to improve infant and young child feeding was an integral part of the intervention. In the preventive arm, this intervention was targeted to pregnant and lactating mothers and mothers of children 0-24 months of age. The education was done using mother's groups In the recuperative arm, the BCC intervention was only targeted to pregnant and lactating women and mothers of malnourished children under the age of five. | Behavioural | Preventive targeting, Recuperative targeting |
Primary outcome
Mean z-scores (height-for-age, weight-for-age, weight-for-height) two years after intervention implemented
Prevalence of undernutrition (stunting, wasting, underweight) two years after implementation of intervention
2 secondary outcomes
Maternal knowledge about child feeding practices recommended through behavioral intervention at 2 years after implementation of intervention;
Feeding practices and other caregiving practices at 2 years after implementation of intervention
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 30 Aug 2012.
- Results publication: PubMed 15646314Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
- Results publication: PubMed 18280329Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95. doi: 10.1016/S0140-6736(08)60271-8.
- Results publication: PubMed 16060227Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. doi: 10.1177/156482650502600210. No abstract available.
- Results publication: PubMed 18287379Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7. doi: 10.1093/jn/138.3.634.
- Results publication: PubMed 20392883Donegan S, Maluccio JA, Myers CK, Menon P, Ruel MT, Habicht JP. Two food-assisted maternal and child health nutrition programs helped mitigate the impact of economic hardship on child stunting in Haiti. J Nutr. 2010 Jun;140(6):1139-45. doi: 10.3945/jn.109.114272. Epub 2010 Apr 14.
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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.
Marie T. Ruel, PhD principal investigator
International Food Policy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified food rations and Education and communication to improve feeding practices in people with Malnutrition, run by International Food Policy Research Institute at 1 site in Haiti.
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 1 inclusion and 1 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 30 Aug 2012. 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 Haiti. 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?
Mean z-scores (height-for-age, weight-for-age, weight-for-height) two years after intervention implemented. The study lists 2 primary outcomes in all. 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 NCT00210418, which also lists 5 linked publications.
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 30 Aug 2012.