Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKristin Clemens
About this trial
Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.
The investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.
The investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
BMI >35 kg/m2
eGFR <15ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater
Disqualifiers
Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)
Type 1 diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide
DrugMaximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.
Virtual Weight Management Coaching
BehavioralVirtual meeting with intervention coach once every 4 weeks for 6 months, where the coach will discuss the goals and progress with participant, nutritional advice, exercise advice, and motivational support.
Treatment groups
880 Participants
are divided into 2 treatment groupsGroup A: Virtual Weight Management ProgramExperimental treatment 2 interventions
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Body Weight
Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts)
Time frame
Baseline to 26 weeks +/- 14 daysSecondary outcomes
1
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
Change in Kidney Disease Quality of Life (KDQOL-36) score across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.
Time frame
Baseline to 26 weeks +/- 14 days2
Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire
Change in health-related quality of life measured using the European Quality of Life 5-Dimension, 5-Level questionnaire across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).
Time frame
Baseline to 26 weeks +/- 14 days3
Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)
Change in functional status measured with KDQOL-36™ scores across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.
Time frame
Baseline to 26 weeks +/- 14 days4
Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.
Measured via EQ-5D-5L (European Quality of Life five-dimensional, five-level generic measure) scores across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).
Time frame
Baseline to 26 weeks +/- 14 daysOther outcomes
1
Change in HbA1c
Change in glycated hemoglobin among participants with diabetes across treatment arms.
Time frame
Baseline to 24 Months2
Hospitalization for Hyperglycemia
Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms
Time frame
Baseline to 24 Months3
Hospitalization for hypoglycemia
Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms.
Time frame
Baseline to 24 Months4
Initiation of Dialysis
Percentage of non-dialysis participants initiating dialysis across treatment arms
Time frame
Baseline to 24 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kristin Clemens
Lead sponsor
Western University, Canada
Sponsor institution
Source ClinicalTrials.gov
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