OBESIAL: A Prospective Interventional Real-world Study of a Multidisciplinary Obesity Management Programme (OBESIAL)
18 agosto 2026 aggiornato da: University of Health Sciences, Algeria
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBESIAL is a prospective pragmatic study involving 300 adults with obesity recruited from healthcare facilities in Algeria and followed for 18 months. The primary comparison evaluates outcomes between participants receiving structured multidisciplinary care (G1, n=150) and those receiving non-structured usual care (G2, n=150). The structured pathway includes coordinated medical follow-up, personalised nutritional intervention, adapted physical activity, therapeutic education, and multidisciplinary support.
Within the structured care group, eligible participants will undergo a nested randomised comparison between G1a (lifestyle intervention plus GLP-1 receptor agonist therapy) and G1b (lifestyle intervention alone) to assess the additional effect of GLP-1 receptor agonist treatment.
The primary outcome is the proportion of participants achieving clinically meaningful weight loss (≥5% of initial body weight) at 18 months. Secondary outcomes include changes in body composition, metabolic parameters, treatment response, adherence, and obesity-related outcomes. Longitudinal analyses will be performed using mixed-effects models, while multivariable approaches will explore factors associated with treatment response.
The findings of the OBESIAL study are expected to provide evidence to support the development and optimisation of structured multidisciplinary obesity care pathways in Algeria and may offer relevant insights for other African healthcare systems.
Tipo di studio
Interventistico
Iscrizione (Stimato)
300
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Mounira Professor Chanegriha. Head of Medicine department, Professor
- Numero di telefono: 3012 +21321905656
- Email: m.chanegriha@univ-alger.dz
Luoghi di studio
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Algiers, Algeria, 16000
- Reclutamento
- Department of Medicine, , Mother and Child Hospital of the Army (MCHA), Algiers University Hospital, Algiers, Algeria.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: G1a: Structured Obesity Care + Semaglutide
Participants assigned to G1 will initially receive the structured obesity care pathway (OBESIAL) for 18 months.
This structured multidisciplinary care includes coordinated medical follow-up, individualized nutritional management adapted to the sociocultural context, a personalized physical activity program, and psychological support according to individual needs.
At month 6, the clinical course is reviewed during a multidisciplinary meeting.
Bariatric surgery constitutes a therapeutic pathway within the structured care group and not a separate study arm based on clinical indication and patient's wishes.
Among participants remaining eligible for pharmacological intervention, an embedded, independent and centralized 1:1 randomization is performed to assign participants to G1a or G1b.
The semaglutide intervention is therefore an adjunct to, and not a replacement for, the structured nutritional, physical activity and behavioural interventions provided within the OBESIAL care pathway.
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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.
Structured care group (G1): Only participants in G1 will undergo the structured care pathway over 18 months.
Altri nomi:
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Comparatore attivo: G1b : Structured care group / lifestyle intervention alone
Participants assigned to G1 initially receive the structured obesity care pathway (OBESIAL) for 18 months, including coordinated medical follow-up, individualized nutritional management adapted to the sociocultural context, a personalized physical activity program, and psychological support according to individual needs.
The structured multidisciplinary assessment involves general practitioners, endocrinologists-diabetologists, dietitians, psychologists and psychiatrists, with referral to organ specialists according to obesity-related comorbidities, including cardiology, pulmonology, gastroenterology, rheumatology and stomatology.
Adapted physical activity interventions are supervised by sports medicine physicians or physiotherapists, with functional capacity assessment performed by rehabilitation specialists.
Participants randomized to G1b continue the structured obesity care pathway without initiation of pharmacological treatment with semaglutide as part of the study intervention.
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Structured care group (G1): Only participants in G1 will undergo the structured care pathway over 18 months.
Altri nomi:
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Comparatore attivo: G2: Non-structured care group
Participants in G2 receive usual, non-structured obesity care delivered independently of the OBESIAL structured care pathway and outside the study coordinating structure. Care is provided in comparable healthcare structures in order to reflect usual clinical practice while limiting differences related to the type or level of healthcare facility. 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 The choice, combination, timing and intensity of these therapeutic options are not determined by the OBESIAL study team. Participants therefore remain under the usual care practices of their healthcare structure throughout the study follow-up, without receiving the standardized multidisciplinary structured care pathway implemented in G1. |
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants Achieving ≥5% Weight Loss at Month 18
Lasso di tempo: 18 months follow-up
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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.
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18 months follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Proportion of participants achieving ≥5% weight loss from randomization baseline at Month 18
Lasso di tempo: From Month 6 to Month 18
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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.
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From Month 6 to Month 18
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Proportion of participants achieving ≥10% weight loss from randomization baseline at Month 18
Lasso di tempo: From Month 6 to Month 18
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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.
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From Month 6 to Month 18
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Proportion of participants achieving ≥15% weight loss from randomization baseline at Month 18
Lasso di tempo: From Month 6 to Month 18
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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.
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From Month 6 to Month 18
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Baseline predictors of weight loss response to semaglutide at Month 18
Lasso di tempo: From Month 6 to Month 18
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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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From Month 6 to Month 18
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Change in glycemic parameters from baseline to Month 18
Lasso di tempo: Baseline (Month 0) to Month 18 for the G1 versus G2. Month 6 to Month 18 for the G1a versus G1b
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Changes in fasting plasma glucose and glycated hemoglobin (HbA1c), measured in mmol/L and %, respectively, from baseline (Month 0) to Month 18, comparing participants receiving structured multidisciplinary obesity care (G1) with those receiving usual non-structured care (G2).
The evolution of these parameters from Month 6, corresponding to the randomization and initiation of semaglutide in G1a, to Month 18 will also be compared between G1a and G1b to assess the additional effect of semaglutide on glycemic parameters.
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Baseline (Month 0) to Month 18 for the G1 versus G2. Month 6 to Month 18 for the G1a versus G1b
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Change in lipid parameters from baseline to Month 18
Lasso di tempo: Baseline (Month 0) to Month 18 for the G1 versus G2.Month 6 to Month 18 for the G1a versus G1b.
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Changes in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, measured in mmol/L, from baseline (Month 0) to Month 18, comparing participants receiving structured multidisciplinary obesity care (G1) with those receiving usual non-structured care (G2).
The evolution of these parameters from Month 6, corresponding to the randomization and initiation of semaglutide in G1a, to Month 18 will also be compared between G1a and G1b to assess the additional effect of semaglutide on lipid parameters
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Baseline (Month 0) to Month 18 for the G1 versus G2.Month 6 to Month 18 for the G1a versus G1b.
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Change in body composition from baseline to Month 18
Lasso di tempo: Months 0, 6, 12, and 18; change from Month 0 to Month 18 for G1 versus G2 and from Month 6 to Month 18 for G1a versus G1b
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Changes in body fat percentage (%), visceral adipose tissue (VAT) area (cm²), and lean mass index (LMI) (kg/m²) from baseline (Month 0) to Month 18, comparing participants receiving structured multidisciplinary obesity care (G1) with those receiving usual non-structured care (G2).
Body composition will be assessed at Months 0, 6, 12, and 18 using bioelectrical impedance analysis and dual-energy X-ray absorptiometry (DXA).
Changes in these parameters from Month 6, corresponding to randomization and initiation of semaglutide in G1a, to Month 18 will also be compared between G1a and G1b to assess the additional effect of semaglutide on body composition.
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Months 0, 6, 12, and 18; change from Month 0 to Month 18 for G1 versus G2 and from Month 6 to Month 18 for G1a versus G1b
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Mounira Chanegriha, Professor, University of health sciences, Faculty of Medicine, Algiers, Algeria
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 gennaio 2026
Completamento primario (Stimato)
23 gennaio 2028
Completamento dello studio (Stimato)
23 gennaio 2028
Date di iscrizione allo studio
Primo inviato
11 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2026
Primo Inserito (Effettivo)
21 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OBESIAL
- MCHA-MED-2026/01 (Altro identificatore: Mother and Child hospital of the Army)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .