BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

NCT ID: NCT06103552

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

Brief 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

Obesity; Knee Osteoarthritis; Hip Osteoarthritis; Arthroplasty Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weight Loss Program Intervention

All study participants will be assigned to the intervention arm of this trial where they will undergo the BLOOM lifestyle program for weight loss. This program is 24 weeks in duration and includes group nutrition coaching with a dietitian, regular physician appointments and access to online support materials. Participants may also choose to pursue weight loss medication or meal replacement therapy, although this is not specifically part of the BLOOM program being studied.

Group Type: EXPERIMENTAL

Building Lifestyle Options for Orthopedic Mobility (BLOOM)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• To be eligible for the study, subjects must meet all the following criteria:

1. Age ≥ 18 years old

2. Body mass index (BMI) ≥ 35 kg/m2

3. Have being identified as a potential orthopedic surgery candidate by the Total Joint Assessment Clinic (TJAC)

4. Have a referral by their primary care practitioner

5. Ready to participate actively in the program (i.e., readiness to change scale score ≥7)

6. Acquisition of the required technology tools and skills to use the virtual platform (the BLOOM program will be conducted via virtual video conference)

7. English comprehension at a level that allows for active participation in the program

Exclusion Criteria

• Subjects who meet any of the following criteria are not eligible for the study:

1. Active eating disorder

2. Active substance use disorder

3. Active smoking

4. Currently or past enrollment in another weight loss program in the previous year prior to enrollment in the study

5. Ongoing pregnancy or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LEAF Weight Loss Clinic

UNKNOWN

Sponsor Role: collaborator

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Judy Shiau

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judy Shiau, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Central Contacts

Lesley Ananny, BA

Role: CONTACT

lananny@ohri.ca

613-701-1222

Ran Cheng, MD

Role: CONTACT

racheng@toh.ca

63-701-1222

Other Identifiers

20230569-01H

Identifier Type: -

Identifier Source: org_study_id