An observational study in Weight Regain, sponsored by E-DA Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by E-DA Hospital · Observational
The treatment for weight loss was more diverse due to the higher prevalence of obesity. In addition to weight loss medications, many patients seek bariatric surgery to treat obesity. Although bariatric surgery was the most effective way, the patients still get weight gain due to failure to control their lives. The failure weight loss is caused by complex risk factors, such as dietary habits, quality of life, physical inactivity, comorbidities remission rate, and more related to the failure weight loss factors. To explore weight gain factors, the study uses many questionnaires, including demographic parameter and exercise frequency survey, the WHOQOL-BREF assessment, The Bariatric Quality of Life Questionnaire (BQL), the Three-Factor Eating Questionnaire (TFEQ-R18), the Yale Food Addiction Scale version 2.0 (YFAS 2.0), and Depression Anxiety Stress Scales-21 (DASS-21). The investigators assess different factors like quality of life, food addiction, preferences, psychological status, and regular examination parameters to identify reasons for unsuccessful weight loss. The study aims to establish the model for the prediction of risk factors after treatment of weight loss so that the tools will help to manage the best weight control for the future.
Obesity is a disease worldwide. Hence, many patients seek many different treatments for obesity. The methods for obesity include medical and surgical treatment. The medicine treatment indication for diabetes previously increased indication to weight loss for obese patients now. Recently, the four approved weight loss medicines by the Taiwan Food and Drug Administration (TFDA) include Orlistat, Liraglutide, Contrave, and Semaglutide. In addition to medications for weight loss, indications for more than 30 body mass index (BMI) and more than 27 BMI with uncontrol obesity-related comorbidities.
Another weight loss treatment was bariatric surgery. The surgical treatment focuses on morbidity obese patients. Decrease food intake and absorb calories by changing the structure of the stomach and intestine to weight loss and improve comorbidities. Moreover, three functions for bariatric surgery by different mechanisms to weight loss outcome, include (1) restriction, (2) malabsorption, (3) mixed function, and which indication for more than 37.5 BMI and more than 32.5 BMI with two or more uncontrol obesity-related comorbidities.
Since obesity is not a condition that can be cured by surgical removal of lesions forever, patients often experience weight loss failure after receiving both medical and surgical treatments. Particularly, the probability of weight loss failure after medical treatment is higher than that after surgical treatment. Complexed risk factors caused failure weight loss from behavioral dietary, quality of life, remission rate of comorbidities, genetic inheritance, physical Inactivity, and psychological status. Moreover, failure weight loss has two definitions (1) weight regain (WR) and (2) insufficient weight loss (IWL). The investigators searched many studies to organize failure weight loss definitions referenced by Surgery for Obesity and Related Disease (SORD) in the American Society for Metabolic and Bariatric Surgery (ASMBS). IWL is defined as less than 50 percent excess weight loss (%EWL) or less than 35 BMI after 18 months. WR is defined as (1) more than the nadir weight of 10 kg (2) more than the nadir weight of 25% EWL (3) more than the nadir weight of 5 BMI (4) successfully reduced to a BMI below 35, but after 1-year post-treatment, it exceeded BMI 35 (5) at any point within 1-year post-treatment, the weight is higher than the lowest weight achieved. (6) the weight regained is more than 15% of the lowest weight achieved. In contrast to weight gain after medicine which is defined by population proportion 5%, 10%, 15%, 20% statistical analysis.
The study was an observational cohort study. The investigators will use the six types of questionnaires (1) Demographic parameters and exercise frequency (2) WHOQOL-BREF scale (3) Bariatric Quality of Life Questionnaire (BQL) (4) Three-Factor Eating Questionnaire (TFEQ-R18) (5) Yale Food Addiction Scale (YFAS)2.0 (6) Depression Anxiety Stress Scales-21 (DASS-21). Approximately 5,000 adults who underwent bariatric surgery between January 2017 and December 2024 have been identified for inclusion. The investigators hypothesize that these risk factors are significantly interrelated and are associated with suboptimal weight loss or weight regain following surgery. The primary aim is to analyze the risk of weight regain across different bariatric treatments and identify factors that can support long-term, quality weight management.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 3,602 is above the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →E-DA Hospital is the lead sponsor of 34 studies on the registry; 7 are open to participants now.
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More than 30 BMI obese patients consent to join the study.
Inclusion 1.65 ≥ Age ≥ 20 years-old. 2.BMI ≥ 30. 3.Once attempted exercise or dietary control. 4.No cognitive deficiency and clear communication. 5. No severe psychotic disorders were evaluated by the psychiatrist. (e.g. schizophrenia, bipolar disorder, or severe depression).
6. Signing the informed consent form for clinical trials.
Exclusion
Participants were treated with anti-obesity medications plus lifestyle intervention therapy Participants were treated with TFDA-approved anti-obesity medications (e.g. Saxenda, Contrave, etc.).
Bariatric surgery group(Restriction procedure): Laparoscopic Sleeve Gastrectomy
Bariatric surgery group(Restriction procedure): One anastomosis gastric bypass
Bariatric surgery group(Restriction procedure): Single Anastomosis Sleeve Ileal Bypass
The proportion of failure weight loss
Compare the proportion of failure weight loss after bariatric surgery and medication plus life intervention at 1, 1.5, and 2 years.
Time frame: Month 6, Year 1, Year 1.5, Year 2
The percentage of total weight loss changes
Change from Baseline in percentage of total weight loss
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Weight change
Change from Baseline in weight change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
BMI change
Change from BMI in weight change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Exercise change
Change from baseline in exercise frequency
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Physiological parameter change
Change from baseline in physiological parameter. 1. Concentration of blood sugar test, such as fasting blood glucose (mg/dL), HbA1c (%), C-peptide (ng/dL), Insulin (μIU/mL). 2. Concentration of blood lipid test, such as total choleserol (mg/dL), TG (mg/dL), HDL-C (mg/dL), LDL-C (mg/dL). Concentration of liver and renal function test, such as ALT (U/L), AST (U/L), eGFR (mL/min/1.73m2), creatnine (mg/dL). 3. Concentration of urine and anemia test, such as uric acid (mg/dL), hemoglobin (g/dL), HCT (%), Fe (ug/dL). 4. Concentration of micro-nutrient test, such as IPTH (pg/mL), Ca (mEq/L), Zinc (ug/dL). Above all, the biochemistry with patients at the hospital.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
The comorbidity remission rate.
Change from baseline in proportion of comorbidity remission
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Complication events.
Change from baseline in proportion of Complication events
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Health quality of life change
Change from Baseline in World Health Organization Quality-of-Life Scale (WHOQOL-BREF).The questionnaire has 28-items and belong to four domains (physical, psychological, social, quality of life). Use a Likert-type five-point scale, and higher the score, the better the quality of life. The 4 domain scores are each converted into a scale from 0 to 100.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Quality of life after weight loss treatment change
Change from Baseline in Bariatric Quality of Life Questionnaire (BQL). The questionnaire consists of two main parts and has 15-items. Obesity comorbidities and complications after treatment.The factors related to quality of life. The total score of both parts ranges from 0 to 78, with a higher score indicating better quality of life.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Eating behavior
Change from Baseline in Three-Factor Eating Questionnaire (TFEQ-R18). The questionnaire has 18-items and consist three domains (1) Cognitive Restraint (CR), (2) Uncontrolled Eating (UE), and (3) Emotional Eating (EE). Use a Likert-type four-point scale, and the total score ranges from 18 to 72, with the higher score, prefer the domain.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Food addiction
Change from Baseline in Yale Food Addiction Scale (YFAS)2.0. The questionnaire has 25-items. Absence of food addiction: 0-1 point. Mild food addiction: 2-3 points. Moderate food addiction: 4-5 points. Severe food addiction: ≥ 6 points. Higher score indicating poorer control to food eat.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Psychiatric status
Change from Baseline in Depression Anxiety Stress Scales-21 (DASS-21). The questionnaire has 21-items and consist three domains. Depression domain has score rang of 0-14 points. Higher score has severe depression. Anxiety domain has score rang of 0-10 points. Higher score has severe Anxiety. Stress domain has score rang of 0-17 points. Higher score has severe Stress.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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E-DA Hospital