OBESIAL: A Prospective Interventional Real-world Study of a Multidisciplinary Obesity Management Programme
NCT07779343 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-08-21
Summary
The OBESIAL (Obesity Structured Intervention in Algeria) study aims to evaluate the clinical, metabolic, and organisational impact of a structured multidisciplinary obesity care pathway implemented under real-world conditions.
Conditions
- Obesity Difficult Airway Airway Management
- Obesity Adult Onset
- Obesity and Cardiovascular Risk
- Obesity Type 2 Diabetes Mellitus
Interventions
- DRUG
-
Semaglutide (Wegovy) weekly injection
Semaglutide (Wegovy®) will be administered as a subcutaneous injection once weekly, with gradual dose escalation according to the recommended dosing schedule for the molecule, up to a target maintenance dose of 2.4 mg once weekly, for 12 months. Semaglutide will be initiated as an adjunct to the structured OBESIAL obesity care pathway in eligible participants randomized to G1a, following a second written informed consent specifically for the pharmacological intervention.
- BEHAVIORAL
-
Behavioral Treatment
Structured care group (G1): Only participants in G1 will undergo the structured care pathway over 18 months. * Individualised nutritional follow-up adapted to the sociocultural context, consisting of eight sessions, including nutritional education sessions lasting 30 minutes and evaluation sessions lasting 15 minutes. * An individually tailored physical activity programme based on baseline functional capacity and associated comorbidities. Participants will be encouraged to attend supervised or structured physical activity sessions three times per week, with adjustments according to tolerance and clinical status. * Psychological support provided according to individual needs, focusing on motivation, emotional eating, barriers to adherence, and behavioural change strategies. The frequency of psychological follow-up will be adapted to patient requirements, reflecting the pragmatic nature of the intervention.
- OTHER
-
Weight loss
The content of care is not standardized or imposed by the OBESIAL protocol and may vary according to local clinical practices, healthcare professionals' habits, available resources, treatment availability, and therapeutic options accessible within the participating healthcare structures. Usual care may include lifestyle and dietary management, physical activity advice or interventions, behavioral support, pharmacological treatment for obesity when clinically indicated and available, including GLP-1 receptor agonist therapy, and other therapeutic options for obesity according to usual clinical practice and individual patient characteristics. Bariatric surgery may also be considered or performed when clinically indicated according to the usual care pathway of the healthcare structure.
Sponsors & Collaborators
-
University of Health Sciences, Algeria
lead OTHER
Principal Investigators
-
Mounira Chanegriha, Professor · University of health sciences, Faculty of Medicine, Algiers, Algeria
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-22
- Primary Completion
- 2028-01-23
- Completion
- 2028-01-23
Countries
- Algeria
Study Locations
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