Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2011
Date assigned
19/10/2011
Last edited
17/07/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 approved on 11th November 2010, IRB Number 348, Protocol ID: 19748
2. Xi'an Jiaotong University, Institutional Review Board approved on 28th November 2010, IRB Number 00003556, Protocol ID: 19748

Study design

Interventional cluster-randomised single-blind multicentre controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

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

Patient

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 for Health [NIH] (USA) (ref: 1 R01 HL106023-0)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stanford University, Shorenstein APARC Asia Health Care Initiative (USA)

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