Impact of Decision Aids on Bariatric Surgery Choice

Taipei Medical University

Status: Completed

Conditions: Obesity, Morbid

Treatments: Behavioral: Shared decision making with decision aids

Study type: Interventional

Funder types: Other

Identifiers

NCT03578211

N201804032

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

DAs group

Experimental group

Description:

Shared decision making using decision aids

Treatment:

Behavioral: Shared decision making with decision aids

Control group

No Intervention group

Description:

Standard oral explanation guided with booklets