Risk Factors Affect Weight Loss Outcomes After Treatment (WRRFA).
NCT Number: NCT06482411
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Weight Regain
Sponsor: E-DA Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2028-12-31
Locations: Chung-Yen Chen, Kaohsiung, Yanchao District, 824, Taiwan

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.

Primary Outcome Measures: 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., Month 6, Year 1, Year 1.5, Year 2
Secondary Outcome Measures: The percentage of total weight loss changes, Change from Baseline in percentage of total weight loss, 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, 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, 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, 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., 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, 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, 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., 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., 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., 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., 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., 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