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.
Adults aged 18-65 years
BMI ≥30 kg/m²
Written informed consent obtained prior to enrolment
Refusal to participate or inability to adhere to follow-up procedures
Pregnancy at enrolment
Recent acute cardiovascular event (<60 days)
Active malignancy
Parallel
Semaglutide (Wegovy) weekly injection
DrugSemaglutide (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
BehavioralStructured 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 interventionThe 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.
Percentage of Participants Achieving ≥5% Weight Loss at Month 18
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.
Proportion of participants achieving ≥5% weight loss from randomization baseline at Month 18
Percentage of participants randomized to G1a or G1b who achieve a weight loss of at least 5% from body weight at the time of randomization (Month 6) to Month 18.
Proportion of participants achieving ≥10% weight loss from randomization baseline at Month 18
Percentage of participants randomized to G1a or G1b who achieve a weight loss of at least 10% from body weight at the time of randomization (Month 6) to Month 18.
Proportion of participants achieving ≥15% weight loss from randomization baseline at Month 18
Percentage of participants randomized to G1a or G1b who achieve a weight loss of at least 15% from body weight at the time of randomization (Month 6) to Month 18.
Baseline predictors of weight loss response to semaglutide at Month 18
Association between baseline characteristics measured at Month 6 and weight loss response from Month 6 to Month 18 among participants randomized to G1a. Weight loss response will be defined as achieving ≥5%, ≥10%, or ≥15% reduction in body weight from the randomization baseline. Baseline characteristics will include age, sex, body weight, body mass index, waist circumference, body composition, glycemic parameters, lipid parameters, and obesity-related comorbidities.
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