Clinical trial NCT06103552: BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients
Official title: Building Lifestyle Options for Orthopedic Mobility: Preoperative Weight Loss and Impact on Health in People Living With Obesity Awaiting Orthopedic Procedure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Knee Osteoarthritis
Hip Osteoarthritis
Arthroplasty Complications
Keywords: Obesity
Body Mass Index
Weight Loss
Noncommunicable Diseases
Surveys and Questionnaires
Metabolic Disease
Arthroplasty
Osteoarthritis
Joint Diseases
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: LEAF Weight Loss Clinic
name: The Ottawa Hospital
First posted: 2023-10-27
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label, single arm, cohort study.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss
timeFrame: 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 outcomes:
measure: Weight - BMI 35-40
timeFrame: Six months
measure: Weight - BMI 40+
timeFrame: Six months
measure: Mediterranean Diet Score
timeFrame: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
measure: Oxford Knee and Hip
timeFrame: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
measure: EQ-5D-5L
timeFrame: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
measure: Decision change
timeFrame: Twelve months
measure: Weight change
timeFrame: Twelve months
Other outcomes:
Locations:
Study officials:
affiliation: The Ottawa Hospital
name: Judy Shiau, MD
role: PRINCIPAL_INVESTIGATOR
References: