BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

Not Applicable

Not yet recruiting

• Conditions: Hip Osteoarthritis; Knee Osteoarthritis; Arthroplasty Complications; Obesity
• Interventions: Behavioral: Building Lifestyle Options for Orthopedic Mobility (BLOOM)

• Registration Number: NCT06103552
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Study Start: 2023-12
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight Loss Program Intervention	Building Lifestyle Options for Orthopedic Mobility (BLOOM)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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
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
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
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.
Decision change	Twelve months	The proportion of patients that have a change of decision for joint arthropathy.