Clinical trial NCT06482411: Risk Factors Affect Weight Loss Outcomes After Treatment (WRRFA).
Official title: Exploration of Effect Weight Loss Outcome Related to Factors After Treatment of Weight Loss (WRRFA).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Weight Regain
Keywords: Obesity
Weight regain
Bariatric surgery
Anti-obesity medications
Lifestyle intervention
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 900
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: More than 30 BMI obese patients consent to join the study.

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The proportion of failure weight loss
timeFrame: Month 6, Year 1, Year 1.5, Year 2
Secondary outcomes:
measure: The percentage of total weight loss changes
timeFrame: 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
measure: Weight change
timeFrame: 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
measure: BMI change
timeFrame: 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
measure: Exercise change
timeFrame: 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
measure: Physiological parameter change
timeFrame: 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
measure: The comorbidity remission rate.
timeFrame: 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
measure: Complication events.
timeFrame: 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
measure: Health quality of life change
timeFrame: 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
measure: Quality of life after weight loss treatment change
timeFrame: 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
measure: Eating behavior
timeFrame: 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
measure: Food addiction
timeFrame: 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
measure: Psychiatric status
timeFrame: 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
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chung-Yen Chen
state: Yanchao District
Study officials:
References: