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

NCT07779343 | Recruiting

• 2 other identifiers: OBESIALMCHA-MED-2026/01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

obesity; adult obesity; multidisciplinary care; lifestyle interventions; GLP-1 receptor agonists

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months follow-up

Secondary Outcomes (7)

• Proportion of participants achieving ≥5% weight loss from randomization baseline at Month 18

  From Month 6 to Month 18

• Proportion of participants achieving ≥10% weight loss from randomization baseline at Month 18

  From Month 6 to Month 18

• Proportion of participants achieving ≥15% weight loss from randomization baseline at Month 18

  From Month 6 to Month 18

• Baseline predictors of weight loss response to semaglutide at Month 18

  From Month 6 to Month 18

• 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

Study Arms (3)

G1a: Structured Obesity Care + Semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide (Wegovy) weekly injection; Behavioral: Behavioral Treatment

G1b : Structured care group / lifestyle intervention alone

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Treatment

G2: Non-structured care group

ACTIVE COMPARATOR

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.

Other: Weight loss

Interventions

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.

G1a: Structured Obesity Care + Semaglutide

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.

Also known as: Structured Care Pathway

G1a: Structured Obesity Care + Semaglutide; G1b : Structured care group / lifestyle intervention alone

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.

Also known as: Non-Structured Usual Care

G2: Non-structured care group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• BMI ≥30 kg/m²
• Written informed consent obtained prior to enrolment

You may not qualify if:

• 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
• Pregnancy occurring during follow-up
• Initiation of chronic treatment associated with weight gain

Sponsors & Collaborators

• University of Health Sciences, Algeria: lead

Study Sites (1)

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

Algiers, 16000, Algeria

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

semaglutide; Behavior Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mounira Chanegriha, Professor

  University of health sciences, Faculty of Medicine, Algiers, Algeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mounira Professor Chanegriha. Head of Medicine department, Professor

CONTACT

+21321905656; m.chanegriha@univ-alger.dz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 21, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): January 23, 2028
• Study Completion (Estimated): January 23, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

AL (1)