- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye), 34752
- Acibadem University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Aktiv 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Intuitive Eating Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Eating Attitudes
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Näringsstörningar
- Övernäring
- Kroppsvikt
- Övervikt
- Beteende, beroendeframkallande
- Tvångsmässigt beteende
- Impulsivt beteende
- Matnings- och ätstörningar
- Patologiska tillstånd, tecken och symtom
- Beteende
- Närings- och metabola sjukdomar
- Tecken och symtom
- Beteende, djur
- Matberoende
- Fetma
- Matningsbeteende
Andra studie-ID-nummer
- ATADEK 2023-21/761
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .