- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07859449
Intuitive Eating Intervention After Bariatric Surgery
Effects of an Intuitive Eating Intervention on Body Weight, Body Image, and Eating Attitudes in Women Who Regained Weight After Bariatric Surgery
This study evaluated the validity and reliability of the Turkish version of the Intuitive Eating Scale-2 (IES-2) in individuals who had undergone bariatric surgery and examined the effects of a 6-week online intuitive eating intervention. The study consisted of two stages. In the first stage, 297 adults aged 18-65 years who had undergone bariatric surgery were included to evaluate the psychometric properties of the Turkish IES-2. Exploratory and confirmatory factor analyses, internal consistency, and test-retest reliability were assessed. In the second stage, a 6-week prospective, non-randomized controlled intervention study was conducted among 60 individuals who had undergone bariatric surgery at least two years previously and had regained at least 20% of their maximum weight loss. Participants received either an online intuitive eating intervention or standard nutritional counseling. Outcomes included intuitive eating behaviors, eating attitudes, body perception, body weight, and body mass index (BMI). The Turkish IES-2 demonstrated a valid and reliable three-factor, 17-item structure. The intervention was associated with improvements in intuitive eating behaviors and reductions in eating attitude scores, while no significant changes were observed in body weight or BMI. The findings suggest that an online intuitive eating intervention may improve intuitive eating behaviors and some eating attitudes among individuals who regain weight after bariatric surgery.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Bariatric surgery is an effective treatment for severe obesity; however, weight regain may occur in a proportion of individuals following surgery and may be accompanied by difficulties in eating behaviors, body perception, and eating attitudes. Intuitive eating is an approach that emphasizes responding to internal hunger and satiety cues, reducing reliance on restrictive eating rules, and developing a more adaptive relationship with food. This approach may be relevant to individuals who experience weight regain after bariatric surgery.
This study was designed in two stages. The first stage focused on evaluating the psychometric properties of the Turkish version of the Intuitive Eating Scale-2 (IES-2) among individuals who had undergone bariatric surgery. The second stage investigated whether a 6-week online intuitive eating intervention could improve intuitive eating behaviors and eating-related outcomes in individuals who had experienced weight regain following bariatric surgery.
The intervention was based on the principles of intuitive eating and was delivered online over six weeks. The intervention aimed to support participants in recognizing and responding to internal hunger and satiety cues, reducing rigid dietary rules, developing a more positive relationship with food and body, and increasing awareness of eating-related behaviors and emotions. The intervention group was compared with participants receiving standard nutritional counseling.
The study was conducted to provide evidence regarding the applicability of intuitive eating as a behavioral approach for individuals experiencing weight regain after bariatric surgery and to contribute to the assessment of intuitive eating in this population using a culturally appropriate measurement instrument.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Istanbul, Turquia (Türkiye), 34752
- Acibadem University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female participants aged 18 to 65 years.
- Previous sleeve gastrectomy performed at least 2 years before enrollment.
- Regain of at least 20% of the maximum weight lost after bariatric surgery.
- Voluntary participation in the study.
- Provision of written informed consent before participation.
Exclusion Criteria:
- Stenosis related to the bariatric surgical procedure during or after surgery.
- Any surgical complication that could affect nutritional intake.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intuitive Eating Intervention
Participants in this arm received a 6-week intuitive eating intervention designed to improve intuitive eating behaviors and eating-related attitudes following weight regain after bariatric surgery. The intervention focused on recognizing internal hunger and satiety cues, reducing rigid dietary rules, increasing awareness of eating behaviors and emotions, and developing a more adaptive relationship with food and body. |
A 6-week intuitive eating intervention consisting of weekly online group sessions, individual intuitive eating counseling sessions, and supportive materials delivered through an online messaging platform. The intervention was adapted for individuals who had undergone bariatric surgery and addressed intuitive eating principles, hunger and satiety awareness, eating behaviors, emotional eating, body respect, self-compassion, mindful eating, joyful movement, and gentle nutrition. |
|
Comparador Ativo: Standard Nutritional Counseling
Participants in this arm received standard nutritional counseling during the study period. The counseling represented the usual nutritional guidance provided to individuals who had undergone bariatric surgery and was used as the comparison condition for the online intuitive eating intervention. |
Weekly one-on-one nutrition counseling provided by an experienced bariatric dietitian for 6 weeks. Standard nutritional recommendations for weight regain following bariatric surgery were provided throughout the follow-up period. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Intuitive Eating Score
Prazo: Baseline and immediately after the 6-week intervention
|
Change in total score of the Turkish 17-item Intuitive Eating Scale for Bariatric Surgery (IES-BS) from baseline to post-intervention. |
Baseline and immediately after the 6-week intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Eating Attitudes
Prazo: Baseline and immediately after the 6-week intervention
|
Change in the total score of the Eating Attitudes Test-26 (EAT-26) from baseline to post-intervention. Higher scores indicate more problematic eating attitudes. |
Baseline and immediately after the 6-week intervention
|
|
Change in Body Image
Prazo: Baseline and immediately after the 6-week intervention
|
Change in body image/body perception score from baseline to post-intervention, assessed using Body Perception Scale . |
Baseline and immediately after the 6-week intervention
|
|
Change in Body Mass Index
Prazo: Baseline and immediately after the 6-week intervention
|
Change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²), from baseline to post-intervention. |
Baseline and immediately after the 6-week intervention
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Excesso de peso
- Comportamental, Viciante
- Comportamento compulsivo
- Comportamento impulsivo
- Alimentação e Distúrbios Alimentares
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Comportamento, animal
- Vício em comida
- Obesidade
- Comportamento Alimentar
Outros números de identificação do estudo
- ATADEK 2023-21/761
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .