Impact evaluation of Oportunidades

ISRCTN	ISRCTN11833436
DOI	https://doi.org/10.1186/ISRCTN11833436
Protocol serial number	N/A
Sponsor	Department of Social Welfare (Mexico)
Funders	National Institute of Child health and Human Development (NICHD) (USA), Fogarty International Center (USA), Mexican Government (Mexico)

Submission date: 08/05/2007
Registration date: 08/08/2007
Last edited: 29/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Gertler
Scientific

Haas School of Business
MC 1900
University of California
Berkeley
California
94720
United States of America

Study information

Primary study design	Interventional
Study design	Randomized controlled trial (Randomized at community level)
Secondary study design	Randomised controlled trial
Scientific title	Impact evaluation of Oportunidades
Study acronym	PROGRESA
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	9000
Total final enrolment	10202
Key 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
Key exclusion criteria	All households with income >20% of national average.
Date of first enrolment	01/01/1997
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Mexico
United States of America

Study participating centre

Haas School of Business

California
94720
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		12/12/2009	29/10/2021	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.