BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06103552
• Collaborator: LEAF Weight Loss Clinic (Other), The Ottawa Hospital (Other)
• Enrollment: 58
• Arm: 1
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Knee Osteoarthritis; Hip Osteoarthritis; Arthroplasty Complications	Behavioral: Building Lifestyle Options for Orthopedic Mobility (BLOOM)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is an open label, single arm, cohort study.This is an open label, single arm, cohort study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Building Lifestyle Options for Orthopedic Mobility: Preoperative Weight Loss and Impact on Health in People Living With Obesity Awaiting Orthopedic Procedure
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Intervention Arm 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.

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.

Outcome Measures

Primary Outcome Measures

1. Weight loss [Weight will be compared from beginning of program to end of program, six months after program completion, and also monthly for months 1-5.]

   The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program

Secondary Outcome Measures

1. Weight - BMI 35-40 [Six months]

   The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program for individuals with a BMI of 35-39.9

2. Weight - BMI 40+ [Six months]

   The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program for individuals with a BMI over 40

3. Mediterranean Diet Score [At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)]

   The change in the Mediterranean Dietary Score between the initial visit and the end of the BLOOM program and 3 and 6 months after

4. Oxford Knee and Hip [At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)]

   The change in the Oxford Hip and Knee Questionnaires between the initial visit and the end of the BLOOM program and three and six months after.

5. EQ-5D-5L [At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)]

   The change in the EQ-5D-5L quality of life (QoL) score between the initial visit and the end of the BLOOM program and three and six months after.

6. Decision change [Twelve months]

   The proportion of patients that have a change of decision for joint arthropathy.

7. Weight change [Twelve months]

   The proportion of patients who continued to lose weight or maintained their weight 3 and 6 months after the end of the program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ottawa Hospital Research Institute
• LEAF Weight Loss Clinic
• The Ottawa Hospital

Investigators

• Principal Investigator: Judy Shiau, MD, The Ottawa Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Judy Shiau, Investigator, Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT06103552
• Other Study ID Numbers: 20230569-01H
• First Posted: Oct 27, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Judy Shiau, Investigator, Ottawa Hospital Research Institute: Obesity; Body Mass Index; Weight Loss; Noncommunicable Diseases; Surveys and Questionnaires; Metabolic Disease; Arthroplasty; Osteoarthritis; Joint Diseases
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Obesity; Weight Loss

Study Results

No Results Posted as of Oct 27, 2023