Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Group Education & Lifestyle Modification's Impact on Weight Loss & Quality Life of Patients With OA

13 januari 2021 bijgewerkt door: Kelly Johnston, Alberta Hip and Knee Clinic

Group Education and Digitally Delivered Lifestyle Modification Program to Enable Weight Loss and Improve Metabolic Health and Quality of Life for Patients With Osteoarthritis and Overweight/Obesity.

Patients referred to Calgary's Alberta Hip & Knee Clinic, while awaiting consultation with an orthopedic surgeon for hip or knee osteoarthritis, will be offered the opportunity to participate in a dietary counseling program with the goal of attaining weight loss prior to surgery. Those patients interested in participating in the program will be offered the opportunity to participate in the research trial.

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

Obesity, osteoarthritis, and metabolic syndrome are interrelated diseases. In addition to surgical management, there is the need to identify and provide earlier non-surgical management for individuals with metabolic and body composition changes that are contributing to osteoarthritis progression.

It has been well-established that is a challenge for clinicians to identify and deliver optimal treatment approaches for patients with osteoarthritis and obesity. The long wait times for orthopedic consultation in Alberta present an excellent opportunity to optimize patients with medical comorbidities and can simultaneously improve the pain and disability from their osteoarthritis. This is also an excellent opportunity to involve patients and their families in co-managing their own disease and working towards better health and less pain and disability.

The "OA Optimization Program" has been developed by Dr Berchuk, FRCPC, Diplomat of the American Board of Obesity Medicine. It is a lifestyle and dietary modification program. In cooperation with Calgary's Alberta Hip and Knee Clinic at Gulf Canada Square, Dr Berchuk will offer patients this program while they await orthopedic consultation. This is an optional program offered to all patients. There is an initial group information session for patients who express interest. For those who choose to enroll, the program begins with a medical assessment by Dr Berchuk. The initial consultation consists of a medical assessment which includes medical history and physical examination, a previous dietary history, a readiness for change assessment, and screening for contraindications to the program. The patients will then attend group counselling sessions every 3 months for one year, or until their surgical date. The group counselling will be supplemented by the Grohealth digital therapeutic nutrition program. Participants return for group counselling sessions at Gulf Canada Square clinic every 3 months until orthopedic consultation and if surgery is deemed appropriate, until surgery.

As with any major lifestyle change, peer support is crucial to long term success. Patients are encouraged to bring their family members to the initial consultation and to group sessions. During the group sessions, Dr Berchuk will use techniques to encourage the building of a peer support network, as well as medical cognitive behavior therapy techniques.

Investigators intend to demonstrate that the use of the OA Optimization program can lead to improvement in Quality of Life measures including pain and disability in patients with severe osteoarthritis, as well as improvements in markers of health such as BMI, waist circumference, blood pressure, medication use in diabetic and hypertensive patients, and markers such as serum lipids and markers of inflammation. It is entirely plausible that with preoperative weight loss and/or improvement in metabolic disease, patients may see such dramatic improvement in their symptoms that they choose to postpone surgery.

Research Question and Objectives:

Can the OA Optimization Program lead to improvement in pain and disability related to severe osteoarthritis? Investigators aim to demonstrate that the use of a lifestyle and dietary counselling program can lead to improvements in pain and disability in patients with severe osteoarthritis.

Can the OA Optimization Program demonstrate significant improvements in obesity, hypertension, hyperlipidemia, and glycemic control? Investigators aim to demonstrate improvements in markers of health such as decreased BMI, decreased waist circumference, decreased medication use in diabetic and hypertensive patients, improvement in biomarkers such as serum lipids and serum markers of systemic inflammation.

Studietype

Ingrijpend

Inschrijving (Verwacht)

100

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Symptomatic osteoarthritis
  • BMI ≥ 25

Exclusion Criteria:

  • Age < 18
  • Currently following a specialized or therapeutic diet
  • Pregnant or breastfeeding
  • Type 1 Diabetes
  • Unable to read or speak English
  • Unwilling to use the digital application

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: All patients referred to the Alberta Hip and Knee Clinic
All patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.
The "OA Optimization Program" is a lifestyle and dietary modification program. All Patients will be offered this optional program while they await orthopedic consultation. There is an initial group information session for participants followed by medical assessment which includes medical history and physical examination, a previous dietary history, a readiness for change assessment, and screening for contraindications to the program. The patients will then attend group counselling sessions every 3 months for 1 year, or until their surgical date.Patients are encouraged to attend sessions with a family member. Improvement in Quality of Life measures including pain and disability in patients with severe osteoarthritis, as well as improvements in markers of health such as BMI, waist circumference, blood pressure, medication use in diabetic and hypertensive patients, and markers such as serum lipids and markers of inflammation will be shown.
Andere namen:
  • Osteoarthritis(OA) Optimization program

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
BMI
Tijdsspanne: every 3 months over 12 months.
Change in BMI compared to last visit
every 3 months over 12 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood pressure
Tijdsspanne: every 3 months over 12 months.
Change in blood pressure compared to last visit
every 3 months over 12 months.
serum lipids and markers of inflammation/ Glycemic acid
Tijdsspanne: every 3 months over 12 months.
Change in blood markers compared to last visit
every 3 months over 12 months.
Health-related quality of life
Tijdsspanne: every 3 months over 12 months.
Health-related quality of life as measured by EQ-5D-5L
every 3 months over 12 months.
Pain and functional limitation
Tijdsspanne: every 3 months over 12 months.
Pain and functional limitation as measured by WOMAC
every 3 months over 12 months.
Medication use
Tijdsspanne: every 3 months over 12 months.
Changes in use of diabetic and blood pressure medication
every 3 months over 12 months.
waist circumference
Tijdsspanne: every 3 months over 12 months.
Comparing waist circumference to last visit
every 3 months over 12 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 oktober 2021

Primaire voltooiing (Verwacht)

1 oktober 2023

Studie voltooiing (Verwacht)

1 oktober 2023

Studieregistratiedata

Eerst ingediend

27 februari 2020

Eerst ingediend dat voldeed aan de QC-criteria

17 juni 2020

Eerst geplaatst (Werkelijk)

19 juni 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 januari 2021

Laatste update ingediend die voldeed aan QC-criteria

13 januari 2021

Laatst geverifieerd

1 januari 2021

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Lifestyle and dietary modification program

3
Abonneren