NCT01304888

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,687

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
Last Updated

July 26, 2012

Status Verified

February 1, 2011

Enrollment Period

2.2 years

First QC Date

February 25, 2011

Last Update Submit

July 25, 2012

Conditions

Keywords

Food consumption

Outcome Measures

Primary Outcomes (1)

  • Child nutritional status

Secondary Outcomes (1)

  • Household food consumption

Other Outcomes (1)

  • Body weight

Study Arms (4)

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

Interventions

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.

Cash + health and nutrition education

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 + nutrition education

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.

Food basket w/o nutrition education
ControlOTHER

No benefits were provided

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Salud Publica

Cuernavaca, Morelos, 62100, Mexico

Location

Related Publications (2)

  • 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.

  • Ramirez-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.

MeSH Terms

Conditions

Malnutrition

Interventions

CASP8 and FADD-Like Apoptosis Regulating ProteinNutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Death Domain Receptor Signaling Adaptor ProteinsAdaptor Proteins, Signal TransducingIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis Factor Receptor-Associated Peptides and ProteinsApoptosis Regulatory ProteinsCarrier ProteinsProteinsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Teresa Gonzalez de Cossio, PhD

    National Institute of public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

October 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

July 26, 2012

Record last verified: 2011-02

Locations