NCT07434557

Brief 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 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 16, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

Weight RegainBariatric SurgeryEmotional EatingEating DisorderNutritional Status

Outcome Measures

Primary Outcomes (9)

  • 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.

    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

    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.

    Postoperative 5-8 years (60-96 months), single assessment

  • Change in waist circumference

    Change in waist circumference measured using standardized anthropometric procedures.

    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.

    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.

    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%).

    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.

    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.

    Postoperative 5-8 years (60-96 months), single assessment

Secondary Outcomes (5)

  • Dietary intake from 3-day food record

    Postoperative 5-8 years (60-96 months), single assessment

  • Glycemic parameters

    Postoperative 5-8 years (60-96 months), single assessment

  • Lipid profile

    Postoperative 5-8 years (60-96 months), single assessment

  • Hematological and iron status parameters

    Postoperative 5-8 years (60-96 months), single assessment

  • Vitamin status parameters

    Postoperative 5-8 years (60-96 months), single assessment

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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%).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mudanya Univesity

Bursa, Bursa, 16160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweightFeeding and Eating DisordersEmotional Eating

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental DisordersFeeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 25, 2026

Study Start

January 2, 2025

Primary Completion

September 10, 2025

Study Completion

March 5, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations