Current partner codePEPTIDESDE
NCT06482411·Not applicable·OBSERVATIONAL

Risk Factors Affect Weight Loss Outcomes After Treatment.

Status

Completed

Phase

Not applicable

Enrollment

3,602

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Jul 1, 2024

  2. Study start

    Jun 27, 2024

  3. Primary completion

    Oct 22, 2025

  4. Study completion

    Oct 22, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 6, 2026

Outcomes

What the study measures.

Primary outcomes

The proportion of failure weight loss

Time frame · Month 6, Year 1, Year 1.5, Year 2

Compare the proportion of failure weight loss after bariatric surgery and medication plus life intervention at 1, 1.5, and 2 years.

Secondary outcomes

The percentage of total weight loss changes

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

Change from Baseline in percentage of total weight loss

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

Change from Baseline in weight change

BMI 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

Change from BMI in weight change

Exercise 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

Change from baseline in exercise frequency

Physiological parameter 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

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.

The comorbidity remission rate.

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

Change from baseline in proportion of comorbidity remission

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

Change from baseline in proportion of Complication events

Health quality of life 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

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.

Quality of life after weight loss treatment 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

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.

Eating behavior

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

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.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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 1. Once underwent bariatric surgery. 2. Once used the GLP-1 receptor agonist. 3. Pregnancy or preparation for pregnancy. 4. Once and presenting gastric cancer. 5. Presenting the other cancer. 6. The abnormal endocrine system causes diseases with obesity. 7. Major organ abnormalities (e.g., kidney failure, liver failure, heart failure, etc.). 8. Gastric ulcer, and severe gastroesophageal reflux. 9. Severe psychiatric disorders (schizophrenia, severe bipolar disorder, and depression, etc.). 10. Bulimia nervosa or anorexia nervosa. 11. Drug and alcohol abuse. 12. Helicobacter pylori is not for bariatric surgery. 13. The following diseases or conditions preclude the use of Contrave: 1)Uncontrolled hypertension, 2) History or current diagnosis of epilepsy, 3) Allergy to this medication, 4) Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications). 14. The following diseases or conditions preclude the use of GLP-1 medication: 1) History or current diagnosis of medullary thyroid carcinoma, 2)History or current diagnosis of Multiple Endocrine Neoplasia syndrome type 2, 3)Allergy to this medication, 4)Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications). 15. The following diseases or conditions preclude the use of Xenical medication: 1) History or current diagnosis of cholestasis, 2) Allergy to this medication, 3) Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications).

Study locations

1 registered sites.

Taiwan. Showing up to 24 locations stored in the fast local snapshot.

Chung-Yen Chen

Kaohsiung City, Yanchao District, Taiwan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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