Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/05/2013
Date assigned
21/05/2013
Last edited
03/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Pre-diabetes is an intermediate stage in the development of diabetes. In China, over 14% of people are affected with pre-diabetes and one to three quarters of them will be affected with diabetes in 10 years. It is well established that the risk of diabetes can be decreased substantially by a whole range of proven guidelines, protocols and methodologies. Unfortunately, most proven methods are seldom used in daily practice and this is especially true in resource-poor rural China. This project aims at developing and evaluating an educative counseling package in preventing diabetes.

Who can participate?
Villagers, over 40 years of age, who have lived in the selected villages for over 6 months can participate in the study.

What does the study involve?
The villages are randomly allocated to one of 7 groups. Group 0 consisting of 3 villages receives an initial counseling package called preliminary eCROPS and the rest of the 6 groups of villages receive an advanced counseling package called refined eCROPS. Plasma glucose (every 12 months), body weight (monthly) and blood pressure (monthly) are measured for each group before and after counseling. The measures are documented for 6 years and the results are analysed for lower incidence of progression into diabetes, decreased body mass index, blood pressure, and increased service use and involvement in healthy dietary and physical activities among pre-diabetics compared to those before counseling and lifestyle education.

What are the possible benefits and risks of participating?
Anticipated benefits:
1. Improved knowledge about diabetes, prevention, and health services from the village doctors
2. Early diagnosis of pre-diabetes, diabetes, potential detection of high blood pressure and other conditions
3. A small gift, given at initial assessment and a villager-friendly educational calendar, for promoting diabetes-related lifestyle modifications, given before the start of each follow-up year.
Potential risks and discomforts:
1. Mild pain
2. Potential loss of privacy if diagnosed with diabetes or pre-diabetes condition
3. Time taken for the assessment and follow-up (about 1 hour each)

Where is the study run from?
Approximately 75 village clinics take part in the study and their names are determined at random.

When is the study starting and how long is it expected to run for?
June 2013 to May 2019.

Who is funding the study?
Natural Science Foundation of China and Lu'an Center for Diseases Control (China)

Who is the main contact?
Dr Rui Feng
xiao816meng@sina.cn

Trial website

Contact information

Type

Scientific

Primary contact

Prof Debin Wang

ORCID ID

Contact details

81
Meishan Road
Anhui Medical University
Hefei
230032
China
0086-0551-65116395
dbwang@vip.sina.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Integrated and sustainable prevention against diabetes in rural China: Lu'an eCROPS demonstration project

Acronym

eCROPS

Study hypothesis

This project aims at devising and evaluating an educative counseling package in preventing diabetes. Bringing the best interventions into practice, integrated with routine services, may be effective and sustainable in preventing diabetes.

Ethics approval

Anhui Medical University Biomedical Ethics Committee; 26th February, 2013; Reference number: 20131162

Study design

Quasi cluster randomized controlled trial using batched implementation strategies

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Diabetes

Intervention

eCROPS: The villages are recruited in 7 blocks within 7 consecutive years respectively. Block 0 (control) involves 3 villages and provides an opportunity for piloting and refining primitive intervention methodologies and protocols. The following 6 blocks consist of 12 villages each and serve as intervention arm.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Fasting glucose: For each block, measurement is taken at baseline and every 12 months (for plasma glucose) or monthly (for body weight and blood pressure) after baseline.

Secondary outcome measures

6 years of consecutive measures and detection of lower incidence of progression into diabetes, decreased body mass index and blood pressure, and increased service use and involvement in healthy dietary and physical activities among pre-diabetics receiving the experimental intervention compared to those at baseline or in the delayed-intervention control condition.

Overall trial start date

01/06/2013

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women who are over 40 years and live in the selected villages for over 6 months in a year are eligible for baseline and biannual follow up screening
2. Villagers with a fasting glucose of 5.6<6.9 mmol/l, who are not currently being treated with oral hypoglycemic medication or insulin, are treated as priority intervention group

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6840

Participant exclusion criteria

1. Those with a baseline fasting glucose of 6.1-6.9 mmol/l but are confirmed as diabetic
2. Those with a fasting glucose of 5.6-6.9 mmol/l but are on treatment with oral hypoglycemic medication or insulin

Recruitment start date

01/06/2013

Recruitment end date

31/05/2019

Locations

Countries of recruitment

China

Trial participating centre

81, Meishan Road, Anhui Medical University
Hefei
230032
China

Sponsor information

Organisation

Natural Science Foundation of China (China)

Sponsor details

83 Shuangqing Road
Haiding District
Beijing
Beijing
100000
China
report@pro.nsfc.gov.cn

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Natural Science Foundation of China and Lu'an Center for Diseases Control (China)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24691410

Publication citations

  1. Results

    Chen P, Chai J, Cheng J, Li K, Xie S, Liang H, Shen X, Feng R, Wang D, A smart web aid for preventing diabetes in rural China: preliminary findings and lessons., J. Med. Internet Res., 2014, 16, 4, e98, doi: 10.2196/jmir.3228.

Additional files

Editorial Notes