MalnutritionNCT01304888
Evaluating the Impact of the Food Support Program (Programa de Apoyo Alimentaria)
A study testing Cash + nutrition education, Food basket + nutrition education and Food basket w/o nutrition education in people with Malnutrition, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial summary
The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in Mexico that do not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malnutrition
- What is being tested?
- Cash + nutrition education, Food basket + nutrition education and Food basket w/o nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,687 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2003to Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Live in a community that does not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Marginalization is a term used in Mexico for the multidimensional assessment of poverty in a community. It takes into account housing quality (including the percent of households without piped water, without sewage and without electricity), income (proportion of household below two times the minimum wage), education (including illiteracy) and urbanization.
- Households within these communities were eligible if they fell below the "needs" poverty line as defined by the Mexican Ministry of Social Development. This corresponds to an income level sufficient to cover basic needs in food consumption, health and education.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of the Programa de Apoyo Alimentaria
The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in Mexico that do not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Marginalization is a term used in Mexico for the multidimensional assessment of poverty in a community.
When the program started in 2003 it provided beneficiary households either a cash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly food basket with a cost to the program of 150 pesos. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table 1). The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the recommended daily energy and protein requirements. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.
A community randomized controlled intervention trial was used to evaluate the impact of the intervention. A random sample of 208 rural communities was drawn from the pool of eligible communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas, Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each community a random sample of 33 households was selected. The baseline survey was conducted from October 2003 to April 2004. After baseline data collection, the 208 selected communities (6,687 households) randomly assigned to one of four study groups: food basket without education (52 communities, 1657 households), food basket with education (52 communities, 1680 households), cash transfer with education (53 communities, 1687 communities) or control (51 communities, 1663 households). Treatment allocation was carried out by the Ministry of Social Development.
- Conditions
- Malnutrition
- Being tested
- Cash + nutrition education, Food basket + nutrition education, Food basket w/o nutrition education, Control
- Keywords
- Food consumption
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash + nutrition educationOther
Cash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. Households received the transfer once every 2 mo. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.
Food basket + nutrition educationOther
Monthly food basket with a cost to the program of 150 pesos. The amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate. The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998). Households received the transfer once every 2 mo. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.
Food basket w/o nutrition educationOther
A monthly food basket with a cost to the program of 150 pesos. The amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate. The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998). Households received the transfer once every 2 mo. Beneficiary households were not required to attend nutrition and health education sessions.
ControlOther
No benefits were provided
| Study group | Role | What they receive |
|---|---|---|
| Food basket w/o nutrition education | Experimental | Not described Receives: Other: Food basket w/o nutrition education |
| Food basket + nutrition education | Experimental | Not described Receives: Other: Food basket + nutrition education |
| Control | Experimental | Not described Receives: Other: Control |
| Cash + health and nutrition education | Experimental | Not described Receives: Other: Cash + nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child nutritional status
Secondary outcomes (1)
Household food consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startOct 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,687 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Secretaría de Desarrollo Social (SEDESOL)
- Investigators
- Teresa Gonzalez de Cossio, PhD, Principal investigator, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304888
- Sponsor's protocol ID
- INSP01
- Status last verified
- Feb 2011
- First submitted
- 25 Feb 2011
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Leroy JL, Gadsden P, Rodriguez-Ramirez S, de Cossio TG. Cash and in-kind transfers in poor rural communities in Mexico increase household fruit, vegetable, and micronutrient consumption but also lead to excess energy consumption. J Nutr. 2010 Mar;140(3):612-7. doi: 10.3945/jn.109.116285. Epub 2010 Jan 20.
PubMed 20089777Ramirez-Luzuriaga MJ, Unar-Munguia M, Rodriguez-Ramirez S, Rivera JA, Gonzalez de Cosio T. A Food Transfer Program without a Formal Education Component Modifies Complementary Feeding Practices in Poor Rural Mexican Communities. J Nutr. 2016 Jan;146(1):107-13. doi: 10.3945/jn.115.215962. Epub 2015 Nov 11.
PubMed 26561408
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of the Programa de Apoyo Alimentaria
- ClinicalTrials.gov ID
- NCT01304888
- Acronym / sponsor ID
- INSP01
- Conditions
- Malnutrition
- Keywords
- Food consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,687 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Secretaría de Desarrollo Social (SEDESOL)
- Study start
- Oct 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 28 Feb 2011 (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 Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in Mexico that do not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Marginalization is a term used in Mexico for the multidimensional assessment of poverty in a community.
When the program started in 2003 it provided beneficiary households either a cash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly food basket with a cost to the program of 150 pesos. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table 1). The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the recommended daily energy and protein requirements. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.
A community randomized controlled intervention trial was used to evaluate the impact of the intervention. A random sample of 208 rural communities was drawn from the pool of eligible communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas, Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each community a random sample of 33 households was selected. The baseline survey was conducted from October 2003 to April 2004. After baseline data collection, the 208 selected communities (6,687 households) randomly assigned to one of four study groups: food basket without education (52 communities, 1657 households), food basket with education (52 communities, 1680 households), cash transfer with education (53 communities, 1687 communities) or control (51 communities, 1663 households). Treatment allocation was carried out by the Ministry of Social Development.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Food basket w/o nutrition education | Experimental | Other: Food basket w/o nutrition education |
| Food basket + nutrition education | Experimental | Other: Food basket + nutrition education |
| Control | Experimental | Other: Control |
| Cash + health and nutrition education | Experimental | Other: Cash + nutrition education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Live in a community that does not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Marginalization is a term used in Mexico for the multidimensional assessment of poverty in a community. It takes into account housing quality (including the percent of households without piped water, without sewage and without electricity), income (proportion of household below two times the minimum wage), education (including illiteracy) and urbanization.
- Households within these communities were eligible if they fell below the "needs" poverty line as defined by the Mexican Ministry of Social Development. This corresponds to an income level sufficient to cover basic needs in food consumption, health and education.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cash + nutrition educationCash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. Households received the transfer once every 2 mo. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced. | Other | Cash + health and nutrition education |
| Food basket + nutrition educationMonthly food basket with a cost to the program of 150 pesos. The amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate. The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998). Households received the transfer once every 2 mo. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced. | Other | Food basket + nutrition education |
| Food basket w/o nutrition educationA monthly food basket with a cost to the program of 150 pesos. The amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate. The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998). Households received the transfer once every 2 mo. Beneficiary households were not required to attend nutrition and health education sessions. | Other | Food basket w/o nutrition education |
| ControlNo benefits were provided | Other | Control |
Primary outcome
Child nutritional status
1 secondary outcome
Household food consumption
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 26 Jul 2012.
- Results publication: PubMed 20089777Leroy JL, Gadsden P, Rodriguez-Ramirez S, de Cossio TG. Cash and in-kind transfers in poor rural communities in Mexico increase household fruit, vegetable, and micronutrient consumption but also lead to excess energy consumption. J Nutr. 2010 Mar;140(3):612-7. doi: 10.3945/jn.109.116285. Epub 2010 Jan 20.
- Derived from this study: PubMed 26561408Ramirez-Luzuriaga MJ, Unar-Munguia M, Rodriguez-Ramirez S, Rivera JA, Gonzalez de Cosio T. A Food Transfer Program without a Formal Education Component Modifies Complementary Feeding Practices in Poor Rural Mexican Communities. J Nutr. 2016 Jan;146(1):107-13. doi: 10.3945/jn.115.215962. Epub 2015 Nov 11.
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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.
Teresa Gonzalez de Cossio, PhD principal investigator
National Institute of public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash + nutrition education, Food basket + nutrition education and Food basket w/o nutrition education in people with Malnutrition, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
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 0 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 26 Jul 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 Mexico. 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?
Child nutritional status. 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 NCT01304888, which also lists 2 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 26 Jul 2012; AzTrials last refreshed its copy on 30 Oct 2026.