Impact of Decision Aids on Bariatric Surgery Choice

Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03578211

Enrollment

140

Registered

2018-07-06

Start date

2018-05-01

Completion date

2020-07-07

Last updated

2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

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.

Interventions

BEHAVIORALShared 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Decisional conflict	One week after intervention	Total scores of decisional conflict scale

Secondary

Measure	Time frame	Description
Decision regret	3 month after bariatric surgery	Total scores of decision regret

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026