Impact of Decision Aids on Bariatric Surgery Choice

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Behavioral: Shared decision making with decision aids

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Zhonghe District
    • New Taipei City, Zhonghe District, Taiwan, 23561
      • Taipei Medical University-Shuang Ho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Yen-Hao Su, MD, Metabolic and Weight Management Center, Shuang-Ho Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): May 16, 2020
• Study Completion (ACTUAL): July 7, 2020

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: N201804032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No