Obesity Adult Onset, Obesity and Cardiovascular Risk, Obesity Difficult Airway Airway Management, Obesity Type 2 Diabetes Mellitus
Conditions
Keywords
obesity, adult obesity, multidisciplinary care, lifestyle interventions, GLP-1 receptor agonists
Brief 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.
Detailed description
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.
Interventions
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.
BEHAVIORALBehavioral 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.
OTHERWeight 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
University of Health Sciences, Algeria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
OBESIAL is a hybrid-design study combining a prospective real-world cohort study with a nested randomized controlled trial. In the first phase, it consists of a prospective non-randomized study comparing, among adults living with obesity in Algeria, a structured obesity care pathway with non-structured usual care in order to evaluate the impact of an integrated multidisciplinary consultation in routine clinical practice. In the second phase, after 6 months of follow-up, a nested randomized controlled trial will be conducted among participants within the structured care pathway who are eligible for pharmacological intervention. This component aims to compare the combination of a GLP-1 receptor agonist with lifestyle interventions versus continuation of lifestyle interventions alone. The total follow-up duration for all participants will be 18 months
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥5% Weight Loss at Month 18 | 18 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving ≥10% weight loss from randomization baseline at Month 18 | From Month 6 to 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 | From Month 6 to 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 | From Month 6 to 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. |
| Change in glycemic parameters from baseline to Month 18 | Baseline (Month 0) to Month 18 for the G1 versus G2. Month 6 to Month 18 for the G1a versus G1b | 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. |
| Change in lipid parameters from baseline to Month 18 | Baseline (Month 0) to Month 18 for the G1 versus G2.Month 6 to Month 18 for the G1a versus G1b. | 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 |
| Proportion of participants achieving ≥5% weight loss from randomization baseline at Month 18 | From Month 6 to 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. |
| Change in body composition from baseline to Month 18 | 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 | 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. |
Countries
Algeria
Contacts
CONTACTMounira Professor Chanegriha. Head of Medicine department, Professor
PRINCIPAL_INVESTIGATORMounira Chanegriha, Professor
University of health sciences, Faculty of Medicine, Algiers, Algeria
Outcome results
None listed