Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/07/2019
Date assigned
12/07/2019
Last edited
12/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Diabetes is a serious chronic disease that affects people worldwide. According to a report by the World Health Organization (WHO), the global prevalence of diabetes doubled between 1980 and 2014 and is approximately 8.5% in the adult population in 2017. Globally, diabetes caused an estimated 1.5 million deaths in 2012. Diabetes is the fifth leading cause of death in Taiwan; with a prevalence of 11.8% in the adult population, but this figure has been rising and is expected to continue to increase. In 1997, Taiwan established the “Diabetes Shared Care Network,” which integrated nationwide medical institutions and adjusted health insurance payments for diabetes care, however, lifestyle change counseling is seldom applied in diabetes prevention and treatment. In recent decades, health and wellness coaching has become a new technique used in the care and management of chronic diseases around the world. Health coaching is a patient-centered, patient-decided approach to disease management. The aim of this study is to find out whether a health coaching intervention can improve patients' blood sugar control and decrease diabetes distress.

Who can participate?
Patients aged 20 - 75 with type 2 diabetes

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The intervention group receive usual care and a health coaching intervention for improving their medical adherence, diet and physical activity and diabetes distress syndrome. The coaching intervention involves monthly face-to-face or telephone or mixed coaching as chosen by the participant, and it lasts for 6 months. The length of the coaching intervention depends on the participant's need, but most of them finish in under 30 mins. The control group have usual care only.

What are the possible benefits and risks of participating?
The possible benefits to participants are improving their blood sugar control, decreasing diabetes distress, and better health behaviors.

Where is the study run from?
Cathay General Hospital, Taipei, Taiwan

When is the study starting and how long is it expected to run for?
May 2019 to July 2021

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Yao-Tsung Chang
D508102002@tmu.edu.tw

Trial website

Contact information

Type

Scientific

Primary contact

Mr Yao-Tsung Chang

ORCID ID

http://orcid.org/0000-0003-1028-8450

Contact details

Wuxing St.
Xinyi Dist.
Taipei
110
Taiwan
+886-911839631
D508102002@tmu.edu.tw

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

An innovative approach for increasing adherence to improve healthy lifestyle, diabetes distress and glycemic control among type 2 diabetes patients, a randomized-control trial on health coaching efficacy

Acronym

Study hypothesis

Health coaching intervention can improve patients' glycemic control and decrease diabetes distress.

Ethics approval

Approved 22/03/2019, Cathay General Hospital (280 Renai Rd. Sec.4, Taipei, Taiwan; Tel: +886 (0)2 27082121; Email: irb@cgh.org.tw), Approval number: CGH-OP108002

Study design

Single-center randomized control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Type 2 diabetes mellitus with low glycemic control

Intervention

Potential eligible patients are screened from their medical records beforehand and randomly assigned to either the intervention group or the control group:
The intervention group will have usual care and a health coaching intervention for improving their medical adherence, diet and physical activity and diabetes distress syndrome. The coaching intervention will involve monthly face-to-face or telephone or mixed coaching as chosen by the participant, and it will last for 6 months. The length of the coaching intervention depends on the participant's need, but most of them will finish in under 30 mins.
The control group have usual care only.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Diabetes distress measured using the Diabetes Distress Scale at baseline, 3 months, and 6 months
2. HbA1c collected from database at baseline, 3 months, and 6 months

Secondary outcome measures

1. Self-efficacy of diabetes management measured using self-designed items at baseline, 3 months, and 6 months
2. Physical activity measured using Goldin Leisure time activity scale at baseline, 3 months, and 6 months
3. Healthy diet measured using Alternate Healthy Eating Index for Taiwan (AHEI-T) at baseline, 3 months, and 6 months
4. Self-measured blood sugar behavior measured using one self-designed question at baseline, 3 months, and 6 months
5. Weight and BMI measured collected from database at baseline, 3 months, and 6 months

Overall trial start date

22/05/2019

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 20 - 75 years old
2. Be diagnosed with Type 2 diabetes for 1 year or above
3. HbA1c was higher than 7.0% in past 6 months
4. Creatinine lower than 1.9 mg/dL in recent test
5. Did not participate in other similar research projects at the time of recruitment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140 (both intervention and control group have 70 persons)

Participant exclusion criteria

1. Type 1 diabetes patient
2. Having cancer
3. Pregnant, or planning to be pregnant during the trial

Recruitment start date

01/09/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

Taiwan

Trial participating centre

Cathay General Hospital
No. 280, Sec. 4, Ren’ai Rd., Da’an Dist.
Taipei
10630
Taiwan

Sponsor information

Organisation

Cathay General Hospital

Sponsor details

c/o Dr Ching-Ling Lin
Endocrinology & Metabolism
280 Renai Rd. Sec.4
Taipei
110
Taiwan
+886 (0)2 27082121 # 3165
work5halfday@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 a peer-reviewed journal within 1 year after the end of the intervention.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Yao-Tsung Chang (D508102002@tmu.edu.tw).

Intention to publish date

31/07/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/07/2019: Trial's existence confirmed by Institutional Review Board.