Impact evaluation of Oportunidades
| ISRCTN | ISRCTN11833436 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11833436 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Haas School of Business
MC 1900
University of California
Berkeley
California
94720
United States of America
Study information
| Study design | Randomized controlled trial (Randomized at community level) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/01/1997 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 9,000; n=506 total communities |
| 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
94720
United States of America
Sponsor information
Department of Social Welfare (Mexico)
Government
Government
c/o Dr Rogelio Gòmez-Hermosillo
Department of Social Welfare
Mexico City
-
Mexico
| Website | http://www.oportunidades.gob.mx/ |
|---|
Funders
Funder type
Government
National Institute of Child health and Human Development (NICHD) (USA)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NICHD
- Location
- United States of America
Fogarty International Center (USA)
Government organisation / Research institutes and centers
Government organisation / Research institutes and centers
- Alternative name(s)
- Fogarty, Fogarty at NIH, John E. Fogarty International Center, John Edward Fogarty International Center, NIH John F. Fogarty International Center, NIH's Fogarty International Center, NIH Fogarty International Center, Fogarty International Center at NIH, Fogarty International Center, U.S. National Institutes of Health (NIH), Fogarty International Center AT THE NATIONAL INSTITUTES OF HEALTH, FIC
- Location
- United States of America
Mexican Government (Mexico)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
