Condition category
Not Applicable
Date applied
08/05/2007
Date assigned
08/08/2007
Last edited
08/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.oportunidades.gob.mx/htmls/quienes_somos.html

Contact information

Type

Scientific

Primary contact

Dr Paul Gertler

ORCID ID

Contact details

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

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 measures

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

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

http://www.oportunidades.gob.mx/

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

federal/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

federal/national government

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes