Effectiveness of short-term health coaching according to willingness of participants in coaching groups: a diabetes coaching pilot study

ISRCTN ISRCTN52454940
DOI https://doi.org/10.1186/ISRCTN52454940
Secondary identifying numbers N/A
Submission date
26/04/2018
Registration date
10/05/2018
Last edited
19/11/2019
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 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

Contact information

Dr Ching-Ling Lin
Scientific

Department of Endocrinology & Metabolism
Cathay General Hospital
280 Renai Rd. Sec.4
Taipei
106
Taiwan

ORCiD logoORCID ID 0000-0002-9548-6300
Phone +886 (0)2 27082121 # 3165
Email work5halfday@cgh.org.tw
Prof Ruey-Yu Chen
Scientific

School of Public Health
Taipei Medical University
No.250, Wu-Hsing Street
Taipei
110
Taiwan

Phone +886 (0)2 27361661 #6521
Email rueyyu@tmu.edu.tw

Study information

Study designSingle-centre two-arm non-blinded interventional quasi-experimental design
Primary study designInterventional
Secondary study designQuasi-experimental design
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleAn 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
Study objectivesHealth coaching intervention could improve type 2 diabetes patients' HbA1c control, self-management efficacy and health behaviors.
Ethics approval(s)Cathay General Hospital, 05/06/2017, ref: CGH-OP106001
Health condition(s) or problem(s) studiedType 2 diabetes
InterventionParticipants 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 typeBehavioural
Primary outcome measureHbA1c (%), measured by biochemical test at baseline, 3 months, 6 months and 1 year
Secondary outcome measuresMeasured 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 study start date05/06/2017
Completion date31/10/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants120
Total final enrolment116
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment05/06/2017
Date of final enrolment31/10/2017

Locations

Countries of recruitment

  • Taiwan

Study participating centre

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

Sponsor information

Cathay General Hospital
Hospital/treatment centre

280 Renai Rd. Sec.4
Taipei
106
Taiwan

Phone +886 (0)2 27082121
Email work5haveday@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 date09/08/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in Diabetes Care
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 30/10/2019 19/11/2019 Yes No

Editorial Notes

19/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.