Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01304888
Other study ID # INSP01
Secondary ID
Status Completed
Phase N/A
First received February 25, 2011
Last updated July 25, 2012
Start date October 2003
Est. completion date December 2005

Study information

Verified date February 2011
Source Instituto Nacional de Salud Publica, Mexico
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 6687
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Cash + nutrition education
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 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 w/o 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.
Control
No benefits were provided

Locations

Country Name City State
Mexico Instituto Nacional de Salud Publica Cuernavaca Morelos

Sponsors (2)

Lead Sponsor Collaborator
Instituto Nacional de Salud Publica, Mexico Secretaría de Desarrollo Social (SEDESOL)

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Leroy JL, Gadsden P, Rodríguez-Ramírez S, de Cossío 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):6 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Body weight No
Primary Child nutritional status No
Secondary Household food consumption No
See also
  Status Clinical Trial Phase
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03268902 - Early Life Interventions for Childhood Growth and Development In Tanzania Phase 2/Phase 3
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT04608656 - Livestock for Health Project N/A
Completed NCT06009198 - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting NCT05257980 - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03628196 - A Nutrition-Focused QIP in Outpatient Clinics
Enrolling by invitation NCT04675229 - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Not yet recruiting NCT06047054 - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Not yet recruiting NCT03150927 - Clinical Study of Novel Probiotic Microbial Compositeā„¢ to Treat Undernourished Young Children N/A
Recruiting NCT02833740 - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition N/A
Recruiting NCT03408067 - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients N/A
Completed NCT02938247 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake N/A
Completed NCT02938234 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake N/A