Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07779343

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

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

Treatments and study arms

Semaglutide (Wegovy) weekly injection

Drug

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 Treatment

Behavioral

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.

Weight loss

Other

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 1818 months follow-up

Percentage of participants achieving a clinically significant weight loss of at least 5% of initial body weight after 18 months of follow-up, compared between participants receiving the structured multidisciplinary obesity care pathway (G1) and those receiving usual non-structured care (G2), under real-world clinical conditions in adults living with obesity in Algeria.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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