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Effects of an intervention based on Eating with Full Attention in patients who underwent Stomach Reduction Surgery and regained weight: a randomized clinical trial

Effects of the Mindfulness-Based Food Awareness Training intervention (Mindfulness-Based Eating Awareness Training - MB-EAT) in patients after Bariatric Surgery: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-458tbcd
Enrollment
Unknown
Registered
2021-03-05
Start date
2021-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Interventions

The study will consist of 60 participants of both sexes, who underwent bariatric surgery at HC-FMRP-USP and regained weight. Individuals will be randomized into two groups, with the intervention group

Sponsors

Faculdade de Medicina de Ribeirão Preto
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Present weight regain after bariatric surgery; bariatric surgery was performed in the last five years (minimum 2 years after surgery), reported binge eating episodes and accepted to participate in the study. Weight gain will be considered for participants who recover 50% of the lost weight achieved in the long term or recovery of 20% of the weight associated with the reappearance of comorbidities (SBCBM, 2015). Binge eating episodes are those participants who meet the criteria established by DSM-V (2014): Eating within a limited period of time (for example, within a period of 2 hours), a quantity of food definitely greater than most people would consume at a similar time, under similar circumstances and feeling of lack of control over the episode (a feeling of not being able to stop or control what or how much one eats)

Exclusion criteria

Exclusion criteria: Current diet for weight loss or use of medications that can affect weight; pregnancy; breast-feeding; presence of psychiatric disorders; personality disorders; severe depression; alcohol abuse and / or being on psychiatric drugs

Design outcomes

Primary

MeasureTime frame
It is expected that after the MB-EAT intervention, weight loss or maintenance will occur in individuals who underwent bariatric surgery, which will be assessed using anthropometric indicators (weight, waist circumference) using a Welmy RIW200 electronic scale (accuracy class III) with a capacity of 200 kg and with the aid of an inextensible measuring tape. As a parameter, a variation of at least 5% of the weight will be used in the pre and post-intervention measurements;It is expected that after the MB-EAT intervention there will be an improvement, maintenance or normalization of the metabolic glycemic indicator if it is altered in the individuals who underwent bariatric surgery, which will be evaluated through blood samples that will be collected for the biochemical examination. The parameter of normality will be used: fasting blood glucose 2.71;It is expected that after the MB-EAT intervention there will be an improvement, maintenance or normalization of the metabolic indicator HDL-cholesterol if it is altered in the individuals who underwent bariatric surgery, which will be evaluated through blood samples that will be collected for the examination biochemical. Normality level will be used as parameter: HDL-cholesterol <40mg/dL;It is expected that after the MB-EAT intervention there will be an improvement, maintenance or normalization of the metabolic indicator LDL-cholesterol if it is altered in the individuals who underwent bariatric surgery, which will be evaluated through blood samples that will be collected for the examination biochemical. The normality level will be used as a parameter: LDL-cholesterol <100 mg / dL optimal, 100 to 129 mg / dL desirable, 130 to 159 mg / dL for borderline;It is expected that after the MB-EAT intervention there will be an improvement, maintenance or normalization of the metabolic indicator triglycerides if it is altered in the individuals who underwent bariatric surgery, which will be evaluated through blood samples that will

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactAna Flavia Silva
anaflavia.s.s@usp.br

Outcome results

None listed

Source: REBEC (via WHO ICTRP)