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OBESIAL: A Prospective Interventional Real-world Study of a Multidisciplinary Obesity Management Programme

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.

ClinicalTrials.gov IDNCT07779343

PhaseNA

Enrollment300

SponsorUniversity of Health Sciences, Algeria

Age18 Years – 65 Years

SexALL

I'm interested View official listing

Conditions studied

Obesity Difficult Airway Airway Management, Obesity Adult Onset, Obesity and Cardiovascular Risk, Obesity Type 2 Diabetes Mellitus

About this study

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.

Primary outcomes

Percentage of Participants Achieving ≥5% Weight Loss at Month 18 (18 months follow-up)

Eligibility information

Inclusion Criteria: * Adults aged 18-65 years * BMI ≥30 kg/m² * Written informed consent obtained prior to enrolment Exclusion Criteria: * Refusal to participate or inability to adhere to follow-up procedures * Pregnancy at enrolment * Severe or unstable comorbidities compromising safety or participation, including: * Recent acute cardiovascular event (\<60 days) * Active malignancy * Severe unstable organic disease * Previous bariatric surgery * Obesity pharmacotherapy within the previous 90 days * Known contraindication to planned therapeutic options * Severe unstable psychiatric disorders * Genetic obesity or obesity secondary to uncontrolled endocrine disease Exclusion Criteria During Follow-up * Pregnancy occurring during follow-up * Initiation of chronic treatment associated with weight gain

Study locations

Department of Medicine, , Mother and Child Hospital of the Army (MCHA), Algiers University Hospital, Algiers, Algeria., Algiers, 16000 Algeria

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.