Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431308
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-28
Brief Title:
Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events
Sponsor:
Ariel University
Organization:
Ariel University
Study Overview
Official Title:
Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms treatment discontinuation rate nutritional parameters eg 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 overweightobesity
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 24 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
The intervention group will receive nutrition guidance before AOM treatment by registered dietitian RD followed by nutrition and behavioral recommendations according to reported gastrointestinal symptoms 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 parameters and QOL will be evaluated by interviews questionnaires and measurements at baseline at the end of Wegovy titration phase 20 weeks T1 and weekly during the study period for GI symptoms assessment
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 24 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
The intervention group will receive nutrition guidance before AOM treatment by registered dietitian RD followed by nutrition and behavioral recommendations according to reported gastrointestinal symptoms 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 parameters and QOL will be evaluated by interviews questionnaires and measurements at baseline at the end of Wegovy titration phase 20 weeks T1 and weekly during the study period for GI symptoms assessment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None