BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

Building Lifestyle Options for Orthopedic Mobility: Preoperative Weight Loss and Impact on Health in People Living With Obesity Awaiting Orthopedic Procedure

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Knee Osteoarthritis; Hip Osteoarthritis; Arthroplasty Complications
• Intervention / Treatment: Behavioral: Building Lifestyle Options for Orthopedic Mobility (BLOOM)

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lesley Ananny, BA; Phone Number: 613-701-1222; Email: lananny@ohri.ca
• Study Contact Backup: Name: Ran Cheng, MD; Phone Number: 63-701-1222; Email: racheng@toh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program	Weight will be compared from beginning of program to end of program, six months after program completion, and also monthly for months 1-5.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight - BMI 35-40	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	Six months
Weight - BMI 40+	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	Six months
Mediterranean Diet Score	The change in the Mediterranean Dietary Score between the initial visit and the end of the BLOOM program and 3 and 6 months after	At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
Oxford Knee and Hip	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.	At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
EQ-5D-5L	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.	At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
Decision change	The proportion of patients that have a change of decision for joint arthropathy.	Twelve months
Weight change	The proportion of patients who continued to lose weight or maintained their weight 3 and 6 months after the end of the program	Twelve months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Ottawa Hospital; LEAF Weight Loss Clinic
• Investigators: Principal Investigator: Judy Shiau, MD, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Osteoarthritis; Arthroplasty; Weight Loss; Joint Diseases; Body Mass Index; Metabolic Disease; Surveys and Questionnaires; Noncommunicable Diseases
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Body Weight Changes; Obesity; Osteoarthritis; Weight Loss; Osteoarthritis, Hip
• Other Study ID Numbers: 20230569-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share IPD with other researchers, nor are we seeking institutional ethical approval for such sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No