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NOT YET RECRUITING
NCT07858331
PHASE4

Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access

Sponsor: Kristin Clemens

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

880

Start Date

2027-01-01

Completion Date

2029-01-01

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

Semaglutide

Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.

BEHAVIORAL

Virtual Weight Management Coaching

Virtual 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.

Locations (2)

St. Joseph's Health Care

London, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada