BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

NCT06103552 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-11-22

No results posted yet for this study

Summary

The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are:

1. Can the BLOOM program support these patients to lose up to 10% of their initial body weight?
2. Will patients continue to lose weight for the next six months after completing the program?
3. Does the BLOOM program help patients to improve their overall quality of life?

Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician.

During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program.

Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.

Conditions

Interventions

BEHAVIORAL

Building Lifestyle Options for Orthopedic Mobility (BLOOM)

This intervention is a lifestyle program with includes dietary coaching from a dietitian and regular doctor appointments with a bariatric medicine specialist over the course of 24 weeks.

Sponsors & Collaborators

  • LEAF Weight Loss Clinic

    collaborator UNKNOWN
  • The Ottawa Hospital

    collaborator OTHER
  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Judy Shiau, MD · The Ottawa Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-12-31
Completion
2025-12-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103552 on ClinicalTrials.gov