Impact of Decision Aids on Bariatric Surgery Choice

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Behavioral: Shared decision making with decision aids

• Registration Number: NCT03578211
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-06
• Primary Completion: 2020-05-16
• Study Completion: 2020-07-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAs group	Shared decision making with decision aids	Shared decision making using decision aids

Primary Outcome Measures

Name	Time	Method
Decisional conflict	One week after intervention	Total scores of decisional conflict scale

Secondary Outcome Measures

Name	Time	Method
Decision regret	3 month after bariatric surgery	Total scores of decision regret

Trial Locations

Locations (1)

Taipei Medical University-Shuang Ho Hospital; 🇨🇳 New Taipei City, Zhonghe District, Taiwan