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Obesity Difficult Airway Airway ManagementOBESIALNCT07779343

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

A study testing Semaglutide (Wegovy) weekly injection, Behavioral Treatment and Weight loss in people with Obesity Difficult Airway Airway Management and Obesity Adult Onset, run by University of Health Sciences, Algeria at 1 site in Algeria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Semaglutide (Wegovy) weekly injection, Behavioral Treatment and Weight loss
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteAlgeria
Study dates
22 Jan 2026to 23 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mounira Professor Chanegriha. Head of Medicine department, Professor contact

+21321905656 ext. 3012

m.chanegriha@univ-alger.dz

Algeria1 site, 1 recruiting
  • Department of Medicine, , Mother and Child Hospital of the Army (MCHA), Algiers University Hospital, Algiers, Algeria.

    Algiers, 16000

    Recruiting

Other trials in Algeria

About this study

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.

Read the 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.

Being tested
Semaglutide (Wegovy) weekly injection, Behavioral Treatment, Weight loss
Keywords
obesity, adult obesity, multidisciplinary care, lifestyle interventions, GLP-1 receptor agonists
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide (Wegovy) weekly injectionDrug

    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 TreatmentBehavioural

    Also called Structured Care Pathway

    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 lossOther

    Also called Non-Structured Usual Care

    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.

Study groups in NCT07779343
Study groupRoleWhat they receive
G1a: Structured Obesity Care + SemaglutideExperimentalParticipants 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.
Receives: Drug: Semaglutide (Wegovy) weekly injection; Behavioral: Behavioral Treatment
G1b : Structured care group / lifestyle intervention aloneActive comparatorParticipants 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.
Receives: Behavioral: Behavioral Treatment
G2: Non-structured care groupActive comparatorParticipants 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.
Receives: Other: Weight loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months follow-up

Secondary outcomes (7)
  1. 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.

    Measured: From Month 6 to Month 18

  2. 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.

    Measured: From Month 6 to Month 18

  3. 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.

    Measured: From Month 6 to Month 18

  4. 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.

    Measured: From Month 6 to Month 18

  5. Change in glycemic parameters from baseline to Month 18

    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.

    Measured: Baseline (Month 0) to Month 18 for the G1 versus G2. Month 6 to Month 18 for the G1a versus G1b

  6. Change in lipid parameters from baseline to Month 18

    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

    Measured: Baseline (Month 0) to Month 18 for the G1 versus G2.Month 6 to Month 18 for the G1a versus G1b.

  7. Change in body composition from baseline to Month 18

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start22 Jan 2026
  3. Primary completion23 Jan 2028 (estimated)
  4. Study completion23 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779343
Sponsor's protocol ID
OBESIAL
Other IDs
MCHA-MED-2026/01
Acronym
OBESIAL
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Semaglutide (Wegovy) weekly injection, Behavioral Treatment and Weight loss in people with Obesity Difficult Airway Airway Management and Obesity Adult Onset, run by University of Health Sciences, Algeria at 1 site in Algeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mounira Professor Chanegriha. Head of Medicine department, Professor (+21321905656 ext. 3012, m.chanegriha@univ-alger.dz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving ≥5% Weight Loss at Month 18 (time frame: 18 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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