OBESIAL: A Prospective Interventional Real-world Study of a Multidisciplinary Obesity Management Programme (OBESIAL)
2026년 8월 18일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
300
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Mounira Professor Chanegriha. Head of Medicine department, Professor
- 전화번호: 3012 +21321905656
- 이메일: m.chanegriha@univ-alger.dz
연구 장소
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Algiers, 알제리, 16000
- 모병
- Department of Medicine, , Mother and Child Hospital of the Army (MCHA), Algiers University Hospital, Algiers, Algeria.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Achieving ≥5% Weight Loss at Month 18
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of participants achieving ≥5% weight loss from randomization baseline at Month 18
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Mounira Chanegriha, Professor, University of health sciences, Faculty of Medicine, Algiers, Algeria
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
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2026년 1월 22일
기본 완료 (추정된)
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2028년 1월 23일
연구 완료 (추정된)
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연구 등록 날짜
최초 제출
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처음 게시됨 (실제)
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- OBESIAL
- MCHA-MED-2026/01 (기타 식별자: Mother and Child hospital of the Army)
개별 참가자 데이터(IPD) 계획
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미정
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아니
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아니
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