An innovative approach for increasing adherence to improve healthy lifestyle, diabetes distress and glycemic control among type 2 diabetes patients

ISRCTN ISRCTN14167790
DOI https://doi.org/10.1186/ISRCTN14167790
Submission date
12/07/2019
Registration date
12/07/2019
Last edited
18/08/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Yao-Tsung Chang
Scientific

Wuxing St., Xinyi Dist.
Taipei
110
Taiwan

ORCiD logoORCID ID 0000-0003-1028-8450
Phone +886-911839631
Email D508102002@tmu.edu.tw

Study information

Study designSingle-center randomized control study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific titleAn 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
Study objectivesHealth coaching intervention can improve patients' glycemic control and decrease diabetes distress.
Ethics approval(s)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
Health condition(s) or problem(s) studiedType 2 diabetes mellitus with low glycemic control
InterventionPotential 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 study start date22/05/2019
Completion date31/07/2021

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants140 (both intervention and control group have 70 persons)
Total final enrolment114
Key inclusion criteria1. 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
Key exclusion criteria1. Type 1 diabetes patient
2. Having cancer
3. Pregnant, or planning to be pregnant during the trial
Date of first enrolment01/09/2019
Date of final enrolment30/06/2020

Locations

Countries of recruitment

  • Taiwan

Study participating centre

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

Sponsor information

Cathay General Hospital
Hospital/treatment centre

c/o Dr Ching-Ling Lin
Endocrinology & Metabolism
280 Renai Rd. Sec.4
Taipei
110
Taiwan

Phone +886 (0)2 27082121 # 3165
Email work5halfday@cgh.org.tw
ROR logo "ROR" https://ror.org/03c8c9n80

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/07/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal within 1 year after the end of the intervention.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Yao-Tsung Chang (D508102002@tmu.edu.tw).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 14/05/2021 01/06/2021 Yes No
Results article 29/10/2021 18/08/2023 Yes No

Editorial Notes

18/08/2023: Publication reference added.
01/06/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/07/2019: Trial's existence confirmed by Institutional Review Board.