Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/04/2018
Date assigned
10/05/2018
Last edited
09/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a serious chronic disease that affects people worldwide and it is the fifth leading cause of death in Taiwan. Since the size of the aging population is growing, the prevalence of diabetes continues to rise, so the disease is likely to continue to cause medical and economic burdens within Taiwan. In recent decades, health and wellness coaching has become a new technique used in the care and management of chronic diseases around the world. So far, health behavior counseling become more and more important in chronic diseases management. But until now, there are almost no behavior consultant service within hospitals in Taiwan. The aim of this study is to find out whether a health coaching intervention could improve type 2 diabetes patients' HbA1c control, self-management efficacy and health behaviors.

Who can participate?
Patients aged 20 to 75 who have had type 2 diabetes for at least one year and an HbA1c of 7.0% or higher in the last 6 months

What does the study involve?
Participants selected the group they wished to join: either a health coaching intervention every two weeks or a health coaching intervention only when they returned for a check-up every 3 months. The coach helps them to set their own HbA1c and behaviour goal. Once they set their 6-month goal, they have to set their action plan and the coach tracks their work in the following six sessions. The coach has International Coach Federation ACC credentials. Both groups have general diabetes education. HbA1c (a measure of how well a person's diabetes is being controlled) is measured by blood test at the start of the study, 3 months, 6 months and 1 year.

What are the possible benefits and risks of participating?
There will be no assured direct benefits to those taking part since it depends on the degree of effort that participants put in. There are no risks of health coaching since both groups have diabetes health education before the intervention. Also, participants can call two certified diabetes educators at any time.

Where is the study run from?
Cathay General Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
June 2017 to October 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Dr Ching-Ling Lin
work5halfday@cgh.org.tw
2. Associate Professor Ruey-Yu Chen
rueyyu@tmu.edu.tw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ching-Ling Lin

ORCID ID

http://orcid.org/0000-0002-9548-6300

Contact details

Department of Endocrinology & Metabolism
Cathay General Hospital
280 Renai Rd. Sec.4
Taipei
106
Taiwan
+886 (0)2 27082121 # 3165
work5halfday@cgh.org.tw

Type

Scientific

Additional contact

Prof Ruey-Yu Chen

ORCID ID

Contact details

School of Public Health
Taipei Medical University
No.250
Wu-Hsing Street
Taipei
110
Taiwan
+886 (0)2 27361661 #6521
rueyyu@tmu.edu.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An innovative approach for increasing adherence to medical regiment and glycaemic control among type II diabetes patients: a randomized controlled trial of hospital-based health coaching

Acronym

Study hypothesis

Health coaching intervention could improve type 2 diabetes patients' HbA1c control, self-management efficacy and health behaviors.

Ethics approval

Cathay General Hospital, 05/06/2017, ref: CGH-OP106001

Study design

Single-centre two-arm non-blinded interventional quasi-experimental design

Primary study design

Interventional

Secondary study design

Quasi-experimental design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Type 2 diabetes

Intervention

Participants were recruited from Cathay General Hospital in Taipei, Taiwan. Two physicians who specialize in endocrine and metabolic disorders screened potential patients with type 2 diabetes mellitus. If a patient met the inclusion criteria, one of the doctors explained the study and assessed his or her willing to participate. Once they agree to join and sign informed consent, participants selected the group they wished to join: (1) coaching intervention every two weeks or (2) coaching intervention only when they returned for a check-up every three months. The study design was not blinded. The health coaching intervention includes one face-to-face coaching session at start and six sessions telephone coaching within six months. Coachees have to set their HbA1c goal and their behavior change goal, then follow up by coach. The coach has International Coach Federation ACC credentials. Both groups have general diabetes education. Data collection to evaluate outcomes difference between baseline and upon completion of the every 3 months within study period.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

HbA1c (%), measured by biochemical test at baseline, 3 months, 6 months and 1 year

Secondary outcome measures

Measured at baseline, 3 months, 6 months and 1 year:
1. Self-management efficacy, measured using Perceived Diabetes Self-Management Scale
2. Physical activity, measured using Godin leisure-time physical activity scale
3. Self-blood glucose monitoring, measured using self-report

Overall trial start date

05/06/2017

Overall trial end date

31/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with type 2 diabetes for at least one year
2. 20 to 75 years old
3. HbA1c of 7.0% or greater in the last six months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Type 1 diabetes mellitus
2. Pregnant or trying to become pregnant
3. Participated in another similar program in the last 6 months
4. Clinically significant depression or cognitive dysfunction
5. Failed to sign informed consent

Recruitment start date

05/06/2017

Recruitment end date

31/10/2017

Locations

Countries of recruitment

Taiwan

Trial participating centre

Cathay General Hospital
280 Renai Rd. Sec.4
Taipei
106
Taiwan

Sponsor information

Organisation

Cathay General Hospital

Sponsor details

280 Renai Rd. Sec.4
Taipei
106
Taiwan
+886 (0)2 27082121
work5haveday@cgh.org.tw

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in Diabetes Care

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Yao-Tsung Chang, who can provide clean SPSS data (.sav). This data will become available once the paper has been published. This data will be completely anonymous, meets the IRB approval requirement, and all variables' definitions will be marked in the .sav data.

Intention to publish date

09/08/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes