BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06103552
• Other study ID #: 20230569-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Ottawa Hospital Research Institute
• Contact: Lesley Ananny, BA
• Phone: 613-701-1222
• Email: lananny[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hip Osteoarthritis
• Knee Osteoarthritis
• Obesity
• Osteoarthritis
• Osteoarthritis, Hip
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	LEAF Weight Loss Clinic, The Ottawa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Decision change	The proportion of patients that have a change of decision for joint arthropathy.	Twelve months
Secondary	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