Impact of Decision Aids on Bariatric Surgery Choice

NCT03578211 | Completed DMC

• 1 other identifier: N201804032
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Decisional conflict

  Total scores of decisional conflict scale

  One week after intervention

Secondary Outcomes (1)

• Decision regret

  3 month after bariatric surgery

Study Arms (2)

DAs group

EXPERIMENTAL

Shared decision making using decision aids

Behavioral: Shared decision making with decision aids

Control group

NO INTERVENTION

Standard oral explanation guided with booklets

Interventions

Shared decision making with decision aids BEHAVIORAL

For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.

DAs group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Zhonghe District, 23561, Taiwan

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yen-Hao Su, MD

  Metabolic and Weight Management Center, Shuang-Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Metabolic and Weight Management Center

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: May 1, 2018
• Primary Completion: May 16, 2020
• Study Completion: July 7, 2020
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)