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Completed

NCT Number: NCT03578211

Impact of Decision Aids on Bariatric Surgery Choice

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Zhonghe District, 23561, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Decisional conflict

    Time frame: One week after intervention

    Total scores of decisional conflict scale

Secondary outcomes

  1. Decision regret

    Time frame: 3 month after bariatric surgery

    Total scores of decision regret

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 6, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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