Condition: Obesity; Drug · Sponsor: Ariel University
The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews. A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy© or Mounjaro© . The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM. Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional…
This description comes directly from the study's public registry record.
Shiri Sherf-dagan, Ph.D · +972747288004 · shiris@ariel.ac.il
Rotem Refaeli · +972545797995 · rotem2310@gmail.com
Always discuss trial participation with your own doctor first.
| Ariel University | Ariel, Israel | Recruiting |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva, Israel | Not Yet Recruiting |
| Assuta Medical Center | Tel Aviv, Israel | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06431308