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NCT Number: NCT07779343

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

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.

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Key information

Conditions

Obesity Difficult Airway Airway Management Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Adult Onset Obesity Type 2 Diabetes Mellitus Obesity and Cardiovascular Risk Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Algiers, 16000, Algeria

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Structured Care Pathway

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.

Other names: Non-Structured Usual Care

Primary outcomes

  1. Percentage of Participants Achieving ≥5% Weight Loss at Month 18

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Baseline predictors of weight loss response to semaglutide at Month 18

    Time frame: 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.

  5. Change in glycemic parameters from baseline to Month 18

    Time frame: 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.

  6. Change in lipid parameters from baseline to Month 18

    Time frame: 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

  7. Change in body composition from baseline to Month 18

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mounira Professor Chanegriha. Head of Medicine department, Professor

CONTACT

[email protected]

+21321905656 ext. 3012

Sponsors and collaborators

Lead sponsor

University of Health Sciences, Algeria

Other

Registry information

Acronym: OBESIAL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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