Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Type 2 diabetes is a chronic condition that causes the amount of sugar in a person’s blood to be too high. It happens when the body doesn’t produce enough insulin or doesn’t respond to insulin very well (insulin resistance). It can cause a number of long-term health problems such as kidney failure and limb amputation, and can lead to partial or complete blindness. It is therefore very important for patients to make changes to their lifestyle and learn how to manage their diabetes. In this study, we are looking at how a modified Chinese version of a set of materials developed to help patients understand and self-manage their condition (Diabetes Education Toolkit) can help them to keep the glucose in the blood at a healthy level (glycemic control). The study’s findings should help to show the importance of people understanding their condition in terms of them better being able to manage their disease and improve their health.

Who can participate?
Adults aged at least 18 with type 2 diabetes, hemoglobin A1c ≥ 7.5%, from eight communities of Shanghai, China.

What does the study involve?
The participants are randomly allocated into one of two groups (an intervention and a control group). Their hemoglobin A1c levels are measured and they take part in a survey that assesses their health and diabetes literacy. The control group then are treated as usual and the intervention group tale part in a comprehensive health literacy course for 12 months. Follow up surveys and measurements are carried out for all patients at 3, 6, 12 and 24 months after the start of the study where we compare the HbA1c level between the two groups.

What are the possible benefits and risks of participating?
The participants in the intervention group will obtain additional education on diabetes self-management. There will be no immediate direct benefit for those in the control group. But there should be benefits to all diabetes patients in the future, particularly for those with low literacy levels, because the results of the study are likely to influence how the government provides healthcare services in the future. There are no risks to taking part.

Where is the study run from?
Fudan University in collaboration with Vanderbilt University and Shanghai CDC (China)

When is the study starting and how long is it expected to run for?
January 2015 to December 2016

Who is funding the study?
China Medical Board (CMB) (USA)

Who is the main contact?
Professor Wanghong Xu

Trial website

Contact information



Primary contact

Prof Wanghong Xu


Contact details

138 Yi Xue Yuan Road

Additional identifiers

EudraCT number number

Protocol/serial number

Grant 13-159

Study information

Scientific title

A randomized trial on using a comprehensive health literacy strategy to improve self-management skills and glycemic control in chinese patients with type 2 diabetes


Study hypothesis

Participants randomized to the intervention arm will have significant improvements in HbA1C, blood pressure, lipids, self-management behavior, self-efficacy, and other patient outcomes important to improving diabetes care when compared to the control group participants.

Ethics approval

IRB of School of Public Health, Fudan University (IRB00002408 & FWA00002399), 28/06/2013, ref. IRB#2013-06-0451

Study design

A cluster randomized controlled trial (RCT)

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Type 2 diabetes


The intervention will include two main components:
1. Modified Chinese version of Diabetes Education Toolkit, a set of plain-language tools to aid provider-patient communication about diabetes management
2. A modified Chinese version of Clear Health Communication Curriculum (CHCC), a structured training program for healthcare providers to improve diabetes-related counseling communication skills, with specific attention to issues of literacy and numeracy
Control group:
Will receive usual care which refers to education according to the Chinese Guideline for Diabetes Care and Education, which is widely used in China.

Intervention type



Not Applicable

Drug names

Primary outcome measure

The primary outcome will be changes in HbA1c at baseline and at 3, 6, 12, and 24 months of intervention. HbA1c level will be measured by a blood test.

Secondary outcome measures

Other measures include self-care behaviors, blood pressure, cholesterol, and utilization of clinical services. Incremental costs per behavioral, biologic and QALY change will also be determined. This will be measured at baseline and at 3, 6, 12, and 24 months of intervention.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patient has a clinical diagnosis of type 2 diabetes
2. Age 18-85 years
3. Most recent HbA1c >=7.5%
4. Patient agrees to participate in the study for the full two years duration

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Poor visual acuity (vision worse than 20/50 using Rosenbaum Pocket Screener)
2. Significant dementia, or psychosis (by health provider report or chart review)
3. Terminal illness with anticipated life expectancy < 2 years

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

138 Yi Xue Yuan Road

Sponsor information


China Medical Board (CMB) (USA)

Sponsor details

2 Arrow Street
MA 02138
United States of America

Sponsor type




Funder type


Funder name

China Medical Board (CMB-OC) (USA)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)


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

Basic results (scientific)

Publication list

2019 results in: (added 02/01/2020)
2014 protocol in:

Publication citations

Additional files

Editorial Notes

02/01/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference.