Obesity & OverweightNCT07434557
Disordered Eating and Recurrent Weight Gain After MBS
An observational study of Obesity & Overweight and Bariatric Surgery, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Obesity represents an increasingly serious public health problem worldwide. According to the World Health Organization, one in eight individuals globally is affected by obesity. Bariatric surgery (BS) is recognized as the most effective treatment for severe obesity and has been shown to significantly improve… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight, Bariatric Surgery, Weight Regain Post Bariatric Surgery
- What is being tested?
- Observational assessment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 5 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-65 years who had undergone metabolic bariatric surgery at least 5 years previously and demonstrated suboptimal clinical response (SCR) or recurrent weight gain (RWG) were included. Participants were evaluated during a single follow-up visit.
Who may be able to join
- Adults aged 18-65 years
- History of metabolic bariatric surgery
- At least 5 years post-surgery
- Individuals presenting either:
- recurrent weight gain after initial successful weight loss, or insufficient weight loss defined as nadir percent total weight loss (%TWL nadir) <20%.
- Recurrent weight gain (RWG) was defined according to IFSO consensus recommendations. RWG (%) was calculated as:
- RWG (%) = (weight regained / maximum weight loss) × 100
- Participants were categorized using a cut-off value of 30% (RWG ≥30% vs. <30%).
Who cannot join
- Pregnant or breastfeeding individuals
- Acute illness or active infection
- Medical conditions limiting study safety (e.g., cancer, type 1 diabetes, renal or hepatic failure, recent stroke or myocardial infarction, nephrolithiasis, substance abuse, eating disorders, severe depression or other major psychiatric disorders, inflammatory bowel disease, neoplasia, cardiac arrhythmia, heart failure, respiratory failure, or systemic corticosteroid therapy)
- Professional athletes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disordered Eating, Emotional Eating, and Nutritional Status in Patients With Recurrent Weight Gain After Metabolic and Bariatric Surgery
Obesity represents an increasingly serious public health problem worldwide. According to the World Health Organization, one in eight individuals globally is affected by obesity. Bariatric surgery (BS) is recognized as the most effective treatment for severe obesity and has been shown to significantly improve obesity-related comorbidities. However, despite initially successful surgical outcomes, a substantial proportion of patients experience insufficient weight loss (IWL) or weight regain (WR) after surgery.
Previous studies have identified multiple factors associated with post-bariatric IWL and WR, including older age, low socioeconomic status, higher baseline body mass index (particularly preoperative BMI >50 kg/m²), type of surgical procedure, hormonal mechanisms, poor adherence to postoperative dietary recommendations, maladaptive eating behaviors, insufficient physical activity, and the presence of psychiatric comorbidities. Among these, behavioral factors appear to play a particularly critical role. Irregular eating patterns such as loss of control eating, maladaptive behaviors such as grazing, non-adherence to dietary guidelines, and a return to preoperative eating habits are frequently associated with weight regain. Additionally, physiological mechanisms, including increased appetite, food cravings, and altered hormonal regulation of energy intake, may further contribute to this process.
Read more
Grazing behavior-defined as repetitive consumption of small amounts of food accompanied by a sense of loss of control-has been consistently associated with poorer weight outcomes after bariatric surgery. A large meta-analysis reported grazing prevalence rates between 16.6% and 46.6%, with weight regain observed in nearly half of post-bariatric patients. Moreover, lack of structured nutritional follow-up has been shown to significantly increase the risk of weight regain. Neurobehavioral changes also occur after surgery: while appetite and responsiveness to palatable foods typically decrease during the first postoperative year, these effects often diminish over time, with hunger, cravings, and portion sizes gradually increasing in some individuals.
Long-term weight regain has been closely linked to disordered eating behaviors, including emotional eating, binge eating, compulsive eating, food addiction, and loss of control eating. Recent studies have demonstrated significant associations between weight regain and binge eating disorder, eating disinhibition, and impulsivity. Qualitative research further highlights that many patients struggle to manage emotional eating and require ongoing psychological and dietary support following surgery.
Despite growing evidence emphasizing the behavioral and psychological components of post-bariatric outcomes, comprehensive studies that simultaneously evaluate nutritional status, eating disorders, and emotional factors in individuals experiencing IWL or WR remain limited. Therefore, the present study aims to assess nutritional status, eating disorder symptoms, and emotional factors in individuals who experience insufficient weight loss or weight regain after bariatric surgery. By integrating anthropometric, nutritional, behavioral, and emotional assessments within the same sample, this study seeks to provide a multidimensional perspective and contribute to the development of more effective multidisciplinary follow-up and psychodietetic interventions.
- Conditions
- Obesity & Overweight, Bariatric Surgery, Weight Regain Post Bariatric Surgery, Eating Disorders, Emotional Eating
- Being tested
- Observational assessment
- Keywords
- Weight Regain, Bariatric Surgery, Emotional Eating, Eating Disorder, Nutritional Status
- Medical subject headings
- Obesity, Overweight, Feeding and Eating Disorders, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentOther
No intervention was applied. This study is a cross-sectional observational assessment including anthropometric, biochemical, and nutritional evaluations, together with the Eating Disorder Examination Questionnaire (EDE-Q) and the Emotional Eater Questionnaire (EEQ), in individuals experiencing insufficient weight loss or weight regain after bariatric surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Change in body weight measured using a calibrated, stationary scale with participants in light clothing and no shoes. Measurements were performed according to standard anthropometric practice to ensure accuracy, with participants instructed to remove heavy garments and accessories before weighing.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Change in body mass index (BMI)
Change in body mass index calculated from measured body weight and height at each assessment
Measured: Postoperative 5-8 years (60-96 months), single assessment
Change in body fat percentage
Body fat percentage was assessed using bioelectrical impedance analysis (BIA) with a Tanita MC-780 MA analyzer (Tanita Corp., Japan) in accordance with European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines. Measurements were performed under standardized conditions with participants wearing light clothing and barefoot.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Change in waist circumference
Change in waist circumference measured using standardized anthropometric procedures.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Outcome: Percent total weight loss at nadir (%TWL nadir)
Percent total weight loss at nadir was calculated as:
%TWL = (preoperative weight - postoperative nadir weight) / preoperative weight × 100.
Postoperative nadir weight was defined as the lowest body weight achieved after surgery.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Percent total weight loss at current follow-up (%TWL current)
Current percent total weight loss was calculated as:
%TWL = (preoperative weight - current body weight) / preoperative weight × 100.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Relative weight regain (%RWG)
Relative weight regain was calculated according to consensus recommendations as:
RWG (%) = (weight regained / maximum weight loss) × 100. Participants were categorized based on a cut-off value of 30% (RWG ≥30% vs. <30%).
Measured: Postoperative 5-8 years (60-96 months), single assessment
Eating disorder symptoms assessed by Eating Disorder Examination Questionnaire (EDE-Q)
Eating disorder symptoms were assessed using the Eating Disorder Examination Questionnaire (EDE-Q), a 28-item self-report instrument developed by Fairburn et al. The validated Turkish version was used. The questionnaire includes subscales assessing restraint, binge eating, shape concern, eating concern, and weight concern. Items (except binge eating frequency items) are rated on a 0-6 Likert scale, with higher scores indicating greater severity of eating disorder psychopathology. Permission for scale use was obtained.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Emotional eating behavior assessed by Emotional Eater Questionnaire (EEQ)
Emotional eating behavior was assessed using the Emotional Eater Questionnaire (EEQ), a 10-item self-report instrument developed by Garaulet et al. The validated Turkish version was used. The scale evaluates loss of eating control, food preference tendency, and guilt related to eating. Items are scored on a 0-3 Likert scale, with higher scores indicating greater emotional eating behavior. Permission for scale use was obtained.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Secondary outcomes (5)
Dietary intake from 3-day food record
Dietary intake was assessed using a 3-day food record including one weekend day. Portion sizes were estimated using a standardized food photograph catalog, and standard recipes were consulted when needed. Macro- and micronutrient intake was analyzed using Nutrition Information Systems software (BEBIS 9, Version 9.0, Istanbul, Turkey).
Measured: Postoperative 5-8 years (60-96 months), single assessment
Glycemic parameters
Fasting glucose metabolism markers including fasting blood glucose, HbA1c, and HOMA-IR were recorded after a minimum of 8 hours of fasting.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Lipid profile
Serum lipid parameters including HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides were recorded after a minimum of 8 hours of fasting.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Hematological and iron status parameters
Hemoglobin, hematocrit, ferritin, and serum iron levels were recorded following at least 8 hours of fasting.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Vitamin status parameters
Serum vitamin B12 and folic acid levels were recorded after a minimum of 8 hours of fasting.
Measured: Postoperative 5-8 years (60-96 months), single assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start2 Jan 2025
- Primary completion10 Sep 2025
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Mudanya University
- Responsible party
- Principal investigator, Seher Şen, Mudanya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434557
- Sponsor's protocol ID
- MUDU-SBE-SS-03
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality protections. The dataset contains sensitive clinical information that could potentially allow participant identification. Data will be reported only in aggregated and de-identified form in publications.