Plain English Summary
Background and study aims
Smoking has a considerable negative impact on the control and treatment of diabetes. However, there is currently a lack of relevant studies in Taiwan on the referral rate of smoking cessation, especially for people with diabetes. Since 2012, the second-generation smoke cessation project has been implemented. All departments in the hospital can refer patients to smoking cessation clinics to quit smoking. However, so far, the referral rate and the 6-month success rate are lower than 30%. This study will be implemented in the Cathay General Hospital, and the major aims are to evaluate the impact of a new approach/intervention to improve smoke cessation referral rate and smoking cessation rate by using health coaching.
Who can participate?
Diabetic patients aged 20-75 who smoke
What does the study involve?
Participants are randomly allocated to the intervention group or the control group. Participants in the intervention group receive a health coaching intervention provided by a single qualified coach. They have an initial face-to-face session and are offered 10- to 20-minute telephone coaching sessions biweekly for six sessions within the first 3 months and three sessions within the last 3 months. Participants in the control group only receive a face-to-face coaching session and measurement at the start of the study and do not have any coaching calls. Smoking cessation rate is measured at the start of the study and at 3-month and 6-month follow-up.
What are the possible benefits and risks of participating?
The possible benefits are successful smoking cessation and improved blood glucose control. There are no risks of participating since this is a behavior coaching study without any invasive intervention, and everyone is free to decide whether to withdraw from the study.
Where is the study run from?
Cathay General Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
August 2020 to July 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Yao-Tsung Chang
promiselove02@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Yao-Tsung Chang
ORCID ID
http://orcid.org/0000-0003-1028-8450
Contact details
No. 250
Wuxing St.
Xinyi Dist.
Taipei City 110
Taipei
110
Taiwan
+886 (0)911839631
promiselove02@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CGH-OP106001
Study information
Scientific title
Effect of health coaching on the willingness and success rate of quitting smoking in diabetics: a randomized controlled trial
Acronym
Study hypothesis
Health coaching can help diabetic patients to quit smoking and reduce smoking more effectively than traditional health education.
Ethics approval
Approved 29/04/2020, Institutional Review Board (IRB) of Cathay General Hospital (Cathay General Hospital, No. 280, Sec. 4, Ren’ai Rd, Da’an Dist, Taipei City 106, Taipei, 10630, Taiwan; +886 (0)2-27082121; irb@cgh.org.tw), ref: CGH-OP109002
Study design
Two-year randomized control intervention design study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Diabetics who smoke
Intervention
Participants are recruited from Cathay General Hospital in Taipei, Taiwan. Two physicians who specialize in endocrine and metabolic disorders screen potential patients with type 2 diabetes mellitus who smoke and recruit them when they return to the hospital. Before recruiting, the doctor will first randomly assign the patient to the intervention group or the control group, and then recruit them to avoid the Hawthorne effect.
The coaching is provided by a single coach who had over 120 hours of certified coach training, received the International Coach Federation’s (ICF) Associated Certified Coach (ACC) credential and master’s level degrees in public health. Patients in the intervention group have an initial face-to-face session, together with baseline measurement, then are offered telephone coaching sessions monthly for 6 months. In the first session, the coach asks each participant to set his or her 6-month HbA1c goal and first behavior change goal. The behavior goal must be one of behaviors related to diabetes self-management, including physical activity, healthy diet, medical adherence, and/or regular self-blood glucose monitoring (SMBG). If a patient has more than one behavior change goal, the coach asks him or her to prioritize the goals. The goal must design followed the “SMART” rule (i.e., specific, measurable, attainable, realistic, and timely). The coach records the goals setting by the patient and the content of the coaching for follow-up and analysis. The only difference from the previous study is that the coaching frequency of this study is changed to once per month.
Each patient in the control group only receives a face-to-face coaching session and baseline measurement at baseline, and they do not have any coaching calls at all.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Measured at baseline, 3-month and 6-month follow-up:
1. Smoking cessation rate measured with general definition of smoking cessation formula, including nicotine dependence scale, daily smoking count and CO test, at 6 months
2. Number of cigarettes per day measured by one self-rating question
Secondary outcome measures
Measured at baseline, 3-month and 6-month follow-up:
1. HbA1c collected from patients medical records
2. BMI collected from patients medical records
3. Diabetes management self-efficacy measured by a single question
4. Smoking cessation self-efficacy measured by a single question
5. Physical activity behavior measured with Godin leisure time physical activity scale
6. Diet measured by Food Frequency Questionnaire
Overall trial start date
01/08/2020
Overall trial end date
31/07/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 20 to 75 years old
2. Diagnosed with type 2 diabetes for at least 1 year
3. Having smoke habit in the past 6 months
4. Not taking other smoking cessation courses at the same time
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Any clinically significant depression or cognitive dysfunction
2. Serious hearing impairment
3. Cannot speak Chinese
4. Does not have phone at home
Recruitment start date
01/08/2020
Recruitment end date
31/07/2022
Locations
Countries of recruitment
Taiwan
Trial participating centre
Cathay General Hospital
No. 280, Sec. 4, Ren’ai Rd., Da’an Dist., Taipei City 106
Taipei
10630
Taiwan
Sponsor information
Organisation
Cathay General Hospital
Sponsor details
Department of Endocrinology and Metabolism
No. 280
Sec. 4
Ren’ai Rd.
Da’an Dist.
Taipei City 106
Taipei
110
Taiwan
+886 (0)2708-2121 #3161
promiselove02@gmail.com
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
The researchers will try to publish if the intervention has a significant result.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Yao-Tsung Chang (promiselove02@gmail.com). The format of the data will be Excel or .sav (SPSS or SAS), and it will be available for at least 3 years under the IRB's approval.
Intention to publish date
01/12/2022
Participant level data
Available on request
Basic results (scientific)
Publication list