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Et tværfagligt vægttabsprogram på AUB-MC

3. november 2026 opdateret af: Marlene Chakhtoura, American University of Beirut Medical Center

Et tværfagligt vægttabsprogram på AUB-MC: En åben etiket pilot randomiseret kontrolleret forsøg

The current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss program, using an innovative and simple dietary intervention at the American University of Beirut Medical Center (AUB-MC). Such intervention is expected to enhance patients' compliance and adherence to lifestyle changes. In addition, the program includes supervised exercise sessions and behavioral therapy. Therefore, our project proposes an evidence based approach to close the obesity treatment gaps.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Libanon
    • Riad El Solh
      • Beirut, Riad El Solh, Libanon, 1107 2020
        • American University of Beirut - Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Lebanese adult with obesity (≥18 years), obesity being defined as BMI ≥ 30 kg/m2
  • Patients who can commit to frequent visit trials as per study protocol
  • Patients not traveling outside Lebanon for at least the 6-month period of the trial
  • Patients tolerating Metformin after a run-in period of 2 weeks

Exclusion Criteria:

  • Patients who have taken other weight reducing drug therapy in the previous 6 months
  • Patients who have undergone bariatric therapy or endoscopic procedure, or planning to do so in the near future (at < 6 months)
  • Patients with diabetes
  • Patients working at AUB-MC, as we will not be able to assess the adherence to study visits nor the feasibility of such a program in the general population, presenting to AUB-MC only for clinical care
  • A family member of a patient already enrolled in the study, as the participants will not be independent
  • Pregnant obese patients
  • Patients with pacemakers
  • Patients known to have hypertension, cardiac, pulmonary, renal or liver disease, active cancer or psychiatric illnesses
  • History of any surgery of less than 6 weeks duration
  • Patients known to have disabling osteoarthritic or orthopedic problems
  • Patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, Cushing disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Multidisciplinary program

Multidisciplinary weight loss program
Andet: Multidisciplinary weight loss program

Diet and behavioral therapy,and supervised exercise sessions

Medicin: Metformin Hcl 850Mg Tab

1 tablet, twice daily
Andet: Control

Standard care
Medicin: Metformin Hcl 850Mg Tab

1 tablet, twice daily

Andet: Standard Care

General lifestyle tips

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean percent weight loss per treatment arm
Tidsramme: 6 months after enrollment

[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100
6 months after enrollment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in weight
Tidsramme: 6 months after enrollment

TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg
6 months after enrollment
Change in BMI
Tidsramme: 6 months after enrollment

TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight.
6 months after enrollment
Change in body composition
Tidsramme: 6 months after enrollment

TANITA BC 418 MA Segmental Body Composition Analyzer will measure total body measurements for: Fat Mass, Fat Free Mass, Total Body Water (in kg)
6 months after enrollment
basal metabolic rate (BMR)
Tidsramme: 6 months after enrollment

TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR
6 months after enrollment
Change in physical fitness (distance)
Tidsramme: 6 months after enrollment

Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: distance covered in meters
6 months after enrollment
Change in resting blood pressure before and after physical exercise
Tidsramme: 6 months after enrollment

Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: resting blood pressure
6 months after enrollment
Change in oxygen saturation before and after physical exercise
Tidsramme: 6 months after enrollment

Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: oxygen saturation
6 months after enrollment
Change in heart rate before and after physical exercise
Tidsramme: 6 months after enrollment

Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: heart rate.
6 months after enrollment
Change in physical fitness (Perceived Exertion)
Tidsramme: 6 months after enrollment

Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered.
6 months after enrollment
Change in levels of appetite hormones and metabolic markers
Tidsramme: 6 months after enrollment

At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various hormones and proteins related to appetite and satiety including Gastric inhibitory polypeptide (GIP), Leptin, Glucagon like peptide 1 (GLP1), Irisin, Insulin, Ghrelin, Orexin, IL6

These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.
6 months after enrollment
Change in levels of Mineral markers and hormones (cross laps)
Tidsramme: 6 months after enrollment

At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Crosslaps (pg/mL).

These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.
6 months after enrollment
Change in levels of Mineral markers and hormones (Osteocalcin)
Tidsramme: 6 months after enrollment

At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Osteocalcin (ng/mL).

These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.
6 months after enrollment
Participants' compliance
Tidsramme: 6 months after enrollment

Adherence to the dietary intervention: [Number of days the dieticians are contacted/ Total number of days] X 100 Adherence to program visits: [Number of visits attended/ Total number of visits] X 100
6 months after enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

American University of Beirut Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. august 2023

Primær færdiggørelse (Anslået)

15. september 2027

Studieafslutning (Anslået)

15. september 2027

Datoer for studieregistrering

Først indsendt

18. juli 2019

Først indsendt, der opfyldte QC-kriterier

10. december 2019

Først opslået (Faktiske)

11. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BIO-2018-0400

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