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Impact of Decision Aids on Bariatric Surgery Choice

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ClinicalTrials.gov Identifier: NCT03578211
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
SU YEN-HAO, Taipei Medical University Shuang Ho Hospital

Brief Summary:
Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Behavioral: Shared decision making with decision aids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DAs group
Shared decision making using decision aids
Behavioral: Shared decision making with decision aids
For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.

No Intervention: Control group
Standard oral explanation guided with booklets



Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: One week after intervention ]
    Total scores of decisional conflict scale


Secondary Outcome Measures :
  1. Decision regret [ Time Frame: 3 month after bariatric surgery ]
    Total scores of decision regret



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
  2. Body mass index (BMI) ≧ 37 kg / m2

Exclusion Criteria:

  1. Endocrine system abnormalities in patients
  2. Drug abuse or mental illness
  3. Major organ dysfunction and can accept surgery
  4. Patients cannot understand Chinese
  5. Age less than 20 years old or more than 70 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578211


Contacts
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Contact: Yen-Hao Su, MD 886-2-22490088 ext 8123 su11066@tmu.eud.tw

Locations
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Taiwan
Taipei Medical University-Shuang Ho Hospital Recruiting
New Taipei City, Zhonghe District, Taiwan, 23561
Contact: Yan-Yin Chen, College    +886-2249-0088 ext 8761    17154@s.tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Principal Investigator: Yen-Hao Su, MD Metabolic and Weight Management Center, Shuang-Ho Hospital

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Responsible Party: SU YEN-HAO, Director of Metabolic and Weight Management Center, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03578211     History of Changes
Other Study ID Numbers: N201804032
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms