- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Istanbul, Turcja (Türkiye), 34752
- Acibadem University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Aktywny komparator: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Intuitive Eating Score
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Eating Attitudes
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia odżywiania
- Przekarmienie
- Masy ciała
- Nadwaga
- Zachowanie, Uzależniający
- Kompulsywne zachowanie
- Zachowanie impulsywne
- Zaburzenia odżywiania i odżywiania
- Stany patologiczne, oznaki i objawy
- Zachowanie
- Choroby żywieniowe i metaboliczne
- Objawy i symptomy
- Zachowanie, zwierzę
- Uzależnienie od jedzenia
- Otyłość
- Zachowanie żywieniowe
Inne numery identyfikacyjne badania
- ATADEK 2023-21/761
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .