Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PROGRESA
Study hypothesis
Oportunidades (http://www.oportunidades.gob.mx/htmls/quienes_somos.html) is a federal program aimed at improving the lives of people in extreme poverty. The program offers supports in education, heath, nutrition and employment for people in extreme poverty.
Study hypothesis: Program participation will be associated with improvements in health outcomes
Ethics approval
1. Human subjects review obtained from Center for Protection of Human Subjects at University of California Berkeley in 2003. Refs: CPHS Protocol #2004-6-128 and CPHS Protocol #2004-6-132
2. Ethics Review Board of National Institute of Public Health in Mexico, approved in 2003
Study design
Randomized controlled trial (Randomized at community level)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Child development, adolescent risk behavior, adult health.
Intervention
Due to budgetary and logistical constraints, the Mexican Government was unable to enroll all eligible families simultaneously; rather, it needed to phase in enrollment over a period of time. For ease of implementation, the Government decided that it would enroll whole communities at a time and that it would enroll them as fast as possible so that no eligible household would be kept out of the program. As a result of this process, the government randomly chose 320 treatment and 186 control communities for a phased roll-out in seven states for a total of 506 experimental communities. Random assignment was generated without weighting using randomization commands in STATA (statistical software); thus, each of the communities was given equal chance of being included. None of the sites was told they would be participating in the study, and information regarding timing of roll-out was not made public.
Key activities: Program benefits are distributed only if children, pregnant women, lactating women, and other family members complied with a series of behavioral changes. The requirements included prenatal care, good baby care and immunization, nutrition monitoring and supplementation, preventive checkups, and participation in educational programs regarding health, hygiene and nutrition. Adult family members were required to attend a bi-annual health check-up, and were encouraged to participate in regular educational sessions at which health, hygiene, and nutrition issues and best practices were discussed. Oportunidades verified that households completed the required health care visits by having medical providers at participating public health clinics provide certification of participation. The control communities started the interventions after 18 months of randomization.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Child development, adolescent risk behavior and adult health were assessed in 2003 by the following:
1. Body mass index (BMI, defined as weight in kilograms divided by the square of height in meters) was used to define overweight (25≤BMI), obesity grade I (30≤BMI), and obesity grade II (35≤BMI) at a follow-up survey in 2003.
2. Uncontrolled hypertension was defined as diastolic blood pressure (DBP)≥90 mm Hg or systolic pressure (SBP) ≥140 mm Hg in accordance with The Joint National Committee on Hypertension at a follow-up survey in 2003.
3. Questionnaires were administered to obtain information about the following:
3.1. Demographic characteristics
3.2. Educational attainment
3.3. Assets (large and small household assets, and vehicles)
3.4. Household construction (presence of dirt floor, electricity or bathroom)
3.5. Land and animals owned
3.6. Household composition (age and sex of all household members)
3.7. Marital status (married/cohabitating or unmarried/living alone)
3.8. Indigenous ethnicity (whether an indigenous language is spoken by the head of household)
3.9. Self-reported health status (distance he/she can walk without being tired)
3.10. Health outcomes (report from doctor regarding status of blood pressure or diabetes within the past five years)
These outcomes will be assessed again in 2007.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/1997
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All households with income <20% of national average
2. Living in one of the following seven states: Guerrero, Hidalgo, Michoacán, Puebla, Querétaro, San Luis Potosí, or Veracruz
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
9,000; n=506 total communities
Participant exclusion criteria
All households with income >20% of national average.
Recruitment start date
01/01/1997
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Mexico
Trial participating centre
Haas School of Business
California
94720
United States of America
Sponsor information
Organisation
Department of Social Welfare (Mexico)
Sponsor details
c/o Dr Rogelio Gòmez-Hermosillo
Department of Social Welfare
Mexico City
-
Mexico
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Child health and Human Development (NICHD) (USA)
Alternative name(s)
NICHD
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Funder name
Fogarty International Center (USA)
Alternative name(s)
FIC
Funding Body Type
government organisation
Funding Body Subtype
Research institutes and centers
Location
United States of America
Funder name
Mexican Government (Mexico)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list