Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2011
Date assigned
19/10/2011
Last edited
30/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anemia is a condition that develops when the blood lacks enough healthy red blood cells or haemoglobin (the part of the red blood cell that binds oxygen), causing the cells in the body to not get enough oxygen. It can be caused by a lack of iron in the diet (iron-deficiency anemia). Anemia affects millions of children in poor areas of China and severely constrains their ability to learn and progress through school. The aim of this study is to find out whether strengthened incentives in primary schools in rural China affect student nutrition, especially anemia. There is very little information available on anemia rates among Chinese children, so this study aims to provide new estimates of anemia prevalence among primary school age children in rural China. Early estimates suggest that prevalence rates are higher than previously believed, ranging between 20% and more than 50% in many rural counties. This study assesses the responses of educators (principals) in poor rural primary schools in China to pay-for-performance rewards for reducing anemia compared with pay-for- performance rewards for increasing test scores, and the health consequences of each. This study is thought to be the first to reward health improvement directly. For the purposes of comparison, the study also measures the responses to information campaigns and unconditional subsidy schemes to assess the health improvement benefits of each. The cost-effectiveness of the various incentive-based approaches for anemia reduction is also calculated. New research suggests that the size of the incentive is less important than the mere existence of the incentive. This study therefore compares the effectiveness of large and smaller incentives for anemia reduction.

Who can participate?
All fourth and fifth grade students (mostly aged 8-12) in the participating schools

What does the study involve?
Participating schools are randomly allocated into five groups. Principals of all of the participating schools receive information about the share of enrolled students who are anemic and learn effective methods for reducing anemia, including vitamin supplements and other diet changes. In addition, they receive information about the close link between anemia, school attendance and educational performance. Principals also receive a fixed per student subsidy to do with as they choose. They are be given a menu of options, including items/services that may help reduce anemia and/or raise student test scores. Group 1 schools receive only the information and subsidy described above. Group 2 schools receive on top of the information and subsidy a monetary reward to reduce anemia rates. Group 3 schools receive on top of the information and subsidy a monetary reward to raise student test scores. Group 4 schools receive on top of the information and subsidy a monetary reward to reduce anemia rates and a monetary reward to raise student test scores. Group 5 schools receive receive on top of the information and subsidy a small monetary reward to reduce anemia rates. Blood haemoglobin levels measured by finger prick testing and math and Chinese test scores are compared between the five groups.

What are the possible benefits and risks of participating?
Student participants may experience better health and educational outcomes. Principals who participate in the study receive nutritional training and an unconditional cash subsidy. Some principals are also offered the chance to earn more money through the financial incentive program.

Where is the study run from?
The study takes place in Northwest China in randomly selected schools scattered across Gansu, Shaanxi and Qinghai provinces.

When is the study starting and how long is it expected to run for?
October 2011 to June 2012

Who is funding the study?
1. National Institutes for Health (NIH) (USA)
2. Stanford University (USA)

Who is the main contact?
Prof. Grant Miller

Trial website

Contact information

Type

Scientific

Primary contact

Prof Grant Miller

ORCID ID

Contact details

117 Encina Commons
Stanford
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIH Award No.: 1 R01 HL106023-01

Study information

Scientific title

Paying for performance and cost effectiveness of strategies to combat anemia in China: a randomised controlled trial

Acronym

Study hypothesis

There is low haemoglobin count among fourth and fifth grade students in poor areas of Northwest China, and that part of the problem is that principals lack information about the problem, they lack the funds necessary to address the problem, and lack incentive to take action.

Ethics approval

1. Stanford University, Institutional Review Board, 11/11/2010, IRB Number 348, Protocol ID: 19748
2. Xi'an Jiaotong University, Institutional Review Board, 28/11/2010, IRB Number 00003556, Protocol ID: 19748

Study design

Interventional cluster-randomised single-blind multicentre controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Iron-deficiency anemia

Intervention

1. Information + Subsidy (65 schools)
All principals of the sample schools will receive both information about anemia and an earmarked operating budget subsidy. They will receive information about the share of enrolled students who are anemic and learn efficacious methods for reducing anemia (including vitamin supplementation and other dietary changes). In addition, they will receive information about the close link between anemia, school attendance and educational performance according to findings published in the academic literature. Principals will also receive a fixed per student subsidy to do with as they choose. They will be given a menu of options, including items/services that may help reduce anemia and/or raise student test scores.

2. Information + Subsidy + Anemia Reduction Incentive (65 schools)
Principals in this subset of schools will receive - on top of the information and subsidy treatments - a monetary reward to reduce anemia rates.

3. Information + Subsidy + Test Score Incentive (65 schools)
Principals in this subset of schools will receive - on top of the information and subsidy treatments - a monetary reward to raise student test scores.

4. Information + Subsidy + Dual Incentive (65 schools)
Principals in this subset of schools will receive - on top of the information and subsidy treatments - a monetary reward to reduce anemia rates AND a monetary reward to raise student test scores.

5. Information + Subsidy + Small Anemia Reduction Incentive (40 schools)
Principals in this subset of schools will receive - on top of the information and subsidy treatments - a small monetary reward to reduce anemia rates.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Haemoglobin concentrations, obtained by finger prick testing using HemoCue 201+ point of-care diagnostics

Secondary outcome measures

1. Scores on standardized subject tests of math and Chinese. Both subject tests will be administered by a team of enumerators.
1.1. The math test is based on questions drawn from a pool of questions that were originally created for The Trends in International Mathematics and Science Study (TIMSS).
1.2. The Chinese test is based on questions originally created for inclusion in the local, curriculum-based examinations.

Overall trial start date

24/10/2011

Overall trial end date

10/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female fourth and fifth grade elementary school students attending randomly selected public elementary schools in poor rural areas of Northwestern China

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

In total, 67,000 students will be part of this study. This is based on the average school size in our expected sample of 219. 300 schools will be included in the sample population.

Participant exclusion criteria

1. Wealthy, urban areas as they are not known to have large nutrition problems
2. Students found to be extremely anaemic - these will be excluded and sent directly to a doctor for treatment
3. Students identified as having thalassaemia

Recruitment start date

24/10/2011

Recruitment end date

10/06/2012

Locations

Countries of recruitment

China

Trial participating centre

117 Encina Commons
Stanford
94305
United States of America

Sponsor information

Organisation

Stanford University (USA)

Sponsor details

450 Serra Mall
Stanford
CA 94305–2004
United States of America

Sponsor type

University/education

Website

http://www.stanford.edu/

Funders

Funder type

Government

Funder name

National Institutes of Health (ref: 1 R01 HL106023-0)

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Stanford University

Alternative name(s)

SU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United States of America

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

30/03/2017: Plain English summary added.