NCT04526743

Brief Summary

Studying the mechanisms of weight regain (WR) may provide much needed insight into sustained obesity management. The aim of this five-year, prospective, multicenter study is to evaluate the association among eating patterns (specifically maladaptive behaviors), certain psychological variables and weight trajectory in the short- and long-term after bariatric surgery (BS). The study will include 2 groups: 1.- Candidates to primary BS undergoing laparoscopic gastric bypass (LGBP) or laparoscopic sleeve gastrectomy (LSG) from September 2020 to September 2021. This group will be evaluated prior to surgery, at 4 months, 1 year, 3 years and 5 years after BS, and 2.- a control group of subjects with obesity not candidates to BS matched with the intervention group for age, sex and BMI prior to BS. They will be evaluated once. The primary variable will be: body weight: total weight lost (%), excess weight lost (%), total weight regained (%), excess of weight regain (%). Information regarding the psychological and behavioral variables will be collected using questionnaires that have been validated in our setting and will be completed by the patients themselves online.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress95%
Sep 2019Sep 2026

Study Start

First participant enrolled

September 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

May 8, 2020

Last Update Submit

August 24, 2020

Conditions

Mental Health IssueEating Behavior

Keywords

obesityeating behaviourweight regainedbariatric surgery

Outcome Measures

Primary Outcomes (4)

  • Total weight lost percent (%).

    Total weight lost \> 25 percent.

    5 years.

  • Excess weight lost: percent (%),

    Excess weight lost \> 50 percent

    5 years

  • Total weight regained: percent (%)

    Total weight regained \> 15%

    5 years

  • Excess of weight regain: percent (%).

    EWR \> 15 percent will be considered as significant

    5 years

Study Arms (2)

BS patients

Candidates to primary BS undergoing laparoscopic gastric bypass (LGBP) or laparoscopic sleeve gastrectomy (LSG) from September 2020 to September 2021. Patients will be evaluated prior to BS and at 4 months, 1, 3 and 5 years after BS.

Behavioral: Questionnaire

no BS patient

A control group of subjects with obesity not candidates to BS matched with the intervention group for age, sex and BMI prior to BS. Patients will be evaluated once.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Psychological and behavioral variables will be collected using questionnaires that have been validated in our setting and will be completed by the patients themselves online.

BS patientsno BS patient

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Candidates to primary BS undergoing laparoscopic gastric bypass (LGBP) or laparoscopic sleeve gastrectomy (LSG) from September 2020 to September 2021 and a control group of subjects with obesity not candidates to BS matched with the intervention group for age, sex and BMI prior to BS.

You may qualify if:

  • Candidate to primary BS from 09/2020 to 09/2021.
  • Subjects with obesity (\>40 kg/m2) not candidates to BS.
  • Internet users.
  • Primary BS: LGBP and LSG.
  • Accept to participate in the study and provide signed informed consent

You may not qualify if:

  • Second time and/or revisional BS.
  • Pregnancy.
  • Presence of intellectual impairment impeding the administration of the psychometric tools.
  • Type 1 diabetes.
  • Dyslexia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Feeding BehaviorObesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lilliam Flores, PhD

    Obesity Unit, Endocrinology and Nutrition Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilliam Flores, PhD

CONTACT

0034658023562lflores@clinic.cat

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2020

First Posted

August 26, 2020

Study Start

September 1, 2019

Primary Completion

September 1, 2021

Study Completion (Estimated)

September 1, 2026

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)