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The Effectiveness of Smoking Cessation Clinics Combined With Coach-assisted Lifestyle Change in Prediabetic Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by National Taiwan University Hospital
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01926041
First received: August 6, 2013
Last updated: January 26, 2016
Last verified: January 2016
  Purpose

Diabetes mellitus (DM) has been established to contribute to cardiovascular comorbidities, malignancies and higher mortalities. The management of DM is not limited to aggressively controlling sugar levels after the diagnosis; instead, should be emphasized more on effective modification for prediabetics. Smoking cessation were also demonstrated to improve insulin resistance. Nowadays, the 2nd-generation cessation program in Taiwan brings higher accessibility. However, there is little evidence on the long-term health outcomes of combining smoking cessation and coach-assisted lifestyle change for the prediabetics in the community.

The present new project extends the original pilot project (NSC 102-2628-B-002-046-MY2 and MOST 104-2314-B-002 -072) from August of 2013. The investigators have been making efforts to promote this project by cooperating with primary care doctors of the community medical groups and corporate nurses. Over 446 prediabetic smokers will be enrolled by July of 2017. The invention includes smoking cessation clinics for up to 16 weeks (from January to December of 2017) and coach-assisted lifestyle change (from January of 2017 to July of 2020 and later) for every participant joining intervention. The lifestyle coaches will help the participants in intervention group reach the goal of at least a 7 percent weight loss within the first 6 months. All smokers with prediabetes in intervention and self-management group are provided with educational materials for lifestyle change. All prediabetic smokers are prospectively followed up every 6 months till July of 2020 and later for smoking status, anthropometric indices and blood tests.

Regarding the potential contribution to the national socio-economic development, this project will strengthen the motivation of smoking cessation in prediabetic smokers. Academically, cox regression will be used to investigate the effectiveness of the smoking cessation combined with coach-assisted lifestyle change on DM prevention in smokers with prediabetes. This prospective project will contribute to community-based diabetes research in preventive medicine.


Condition Intervention
Diabetes Mellitus
Cigarette Smoking
Prediabetes
Other: Smoking cessation clinics
Behavioral: Coach-assisted lifestyle change

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effectiveness of Smoking Cessation Clinics Combined With Coach-assisted Lifestyle Change in Prediabetic Smokers

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Diagnosis of diabetes mellitus by ADA criteria [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    The primary outcome is DM, defined as having repeatedly at least one of the following criteria: 1) plasma glucose ≥126 mg/dL (7.0 mmol/L) in the fasting state; 2) plasma glucose ≥200 mg/dL (11.1 mmol/L) randomly with hyperglycemic symptoms or two hours after a 75-g oral glucose load; 3) A1C ≥6.5%;20 or under medications for physician-diagnosed DM.


Secondary Outcome Measures:
  • A1C Change and Regression to Normoglycemia [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    Normoglycemia is defined as having all the following for over 3 months: 1) plasma glucose <100 mg/dL (5.6 mmol/L) in the fasting state; 2) plasma glucose <140 mg/dL (7.8 mmol/L) two hours after a 75-g oral glucose load; 3) A1C <5.7%, in the absence of diabetic medications.

  • Diagnoses of cardiovascular events [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    by specialists

  • Chronic kidney disease progression [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    including change in eGFR and microalbuminuria

  • Chronic hepatitis or cirrhosis progression [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    confirmed by ultrasonography or advanced image or pathology studies

  • Malignancy incidence [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    confirmed by national cancer registry system


Other Outcome Measures:
  • All-cause mortality [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    Deaths are ascertained by computer linkage to the national death registry (death certificates were created by the Department of Health, Taiwan) using ID numbers and these death certificates have been validated.


Estimated Enrollment: 446
Study Start Date: August 2013
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The invention includes smoking cessation clinics for up to 16 weeks (from January to December of 2017) and coach-assisted lifestyle change (from January of 2017 to July of 2020 and later) for every participant joining intervention. Each participant in intervention group receives counseling for individualized smoking cessation techniques at each visit. In addition, each participant is assigned two lifestyle coaches giving weekly and standardized instruction in diet and physical activity to help reach the goals of at least a 7 percent weight loss within the first 6 months. Each coach of physical activity offers supervised physical activity sessions at least two times per week (perhaps through cell phone apps). We do not prescribe the nicotine replacement therapy because it may induce insulin resistance and confound our study outcome. Bupropion is not available for smoking cessation in our institutions.
Other: Smoking cessation clinics Behavioral: Coach-assisted lifestyle change
No Intervention: Self-management
Participants who decide NOT to attend the intervention program are classified as self-management group. All smokers with prediabetes in intervention and self-management group are provided with educational materials for lifestyle change. They are still provided with educational materials of standardized diet and exercise. They are prospectively followed up every 6 months till July of 2020 and later for FTND scores, breath CO levels, anthropometric indices and blood tests (Table 1, Figure 1). The skills of body weight self-management (with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week)19 are delivered through educational materials.

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  Eligibility

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged from 30 to 75 years
  • Prediabetics (ADA criteria): including prediabetic smokers and non-smokers

Exclusion Criteria:

  • Acute cardiac conditions within 3months
  • Acute renal failure
  • Chronic glomerulonephritis
  • Polycystic kidney disease
  • Use of diabetic medications, steroids, lithium or antipsychotics
  • Pregnancy or breast-feeding
  • Malignancy.
  • The elderly adults visiting two or more hospitals due to multiple diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926041

Contacts
Contact: Chien-Hsieh Chiang, MD, MPH +886-920511256 jiansie@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Yun-Lin branch Recruiting
Yunlin, Taiwan, 640
Contact: Chien-Hsieh Chiang, MD, MPH    +886-9-20511256    jiansie@ntu.edu.tw   
Contact: Kuo-Chin Huang, MD, PhD         
Principal Investigator: Chien-Hsieh Chiang, MD, MPH         
Sub-Investigator: Kuo-Chin Huang, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Ministry of Science and Technology, Taiwan
Investigators
Principal Investigator: Chien-Hsieh Chiang, MD, MPH National Taiwan Univeristy Hospital Yun-Lin Branch & College of Medicine
  More Information

Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01926041     History of Changes
Other Study ID Numbers: 201303041RINB 
Study First Received: August 6, 2013
Last Updated: January 26, 2016
Health Authority: Taiwan: Ministry of Health and Welfare

Keywords provided by National Taiwan University Hospital:
community
preventive medicine
prediabetes
smoking cessation

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on September 23, 2016