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