Weight Loss Before Total Joint Arthroplasty Using A Remote Dietitian and Mobile App

NCT04330391 | Completed

• 1 other identifier: 2020P000322
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this trial is to assess the impact of a 12-week remote dietitian supervised dietary and physical activity weight loss intervention and mobile app for patients with morbid obesity prior to undergoing total joint arthroplasty of the hip or knee. The hypothesis is that that the intervention will result in: 1) greater weight loss than usual care, 2) a higher percentage of patients eligible to undergo surgery by having a body mass index (BMI) below the standard cutoff of 40 kg/m2, and 3) a higher percentage of patients undergoing surgery within six months of study enrollment.

Conditions

Arthroplasties, Replacement; Weight Loss; Nutrition

Keywords

Arthroplasty; Weight loss; Health coach; dietitian

Outcome Measures

Primary Outcomes (1)

• Percentage of weight lost or gained from baseline

  The percentage of weight lost or gained will be determined by calculating the difference in final weight and baseline weight for each participant, divided by the baseline weight. Weights will be recorded at a Partners Healthcare facility of the patients' choice, such as at their surgeon's clinic.

  Final weights will be recorded at 12 weeks (10-14 weeks) after study enrollment. The baseline weight will be recorded at enrollment.

Secondary Outcomes (8)

• Percentage of patients eligible to undergo total joint arthroplasty (TJA)

  This outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.

• Percentage of patients undergoing total joint arthroplasty (TJA)

  This outcome will be evaluated for each subject at 6 months after study enrollment.

• Number of completed video call sessions with dietitian

  This outcome will be assessed 14 weeks after enrollment.

• Change from baseline in Paving Wheel Wellness score

  Baseline surveys are completed at enrollment. End-of-study surveys are assessed at 10-14 weeks after enrollment.

• Change from baseline in HbA1c

  Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.

Study Arms (2)

Usual Care

NO INTERVENTION

Individuals randomized to the usual care group will receive standard care. This may include a physical therapist and/or nutritionist referral. Brigham and Women's Hospital offers several programs for patients interested in losing weight, including the Nutrition Wellness Service (NWS) and Program for Weight Management (PWM). Insurance coverage for these programs varies by patient insurance.

Intervention

EXPERIMENTAL

Intervention subjects will use the Nutrimedy mobile app and be connected at enrollment with a registered dietitian who will contact intervention participants weekly or bi-weekly via video calls and unlimited in-app text messaging for up to three months. The first week will include either one 55-minute video session or two 25-minute sessions. Weeks 2-4 will have weekly 25-minute video calls, and weeks 5-12 will have biweekly 25-minute sessions for a total of 8-9 sessions over 12 weeks. Together, participants and dietitians will come up with goals for the 12 weeks, and dietitians will check on progress toward these goals using in-app tools such as food logs and messaging between video calls. All patients will be encouraged to lose at least 20 pounds with a goal BMI\<40 kg/m2 after 12 weeks. The intervention group will also receive all aspects of the usual care arm including the opportunity to have a physical therapist and/or nutritionist referral.

Behavioral: Remote dietitian supervised weight loss intervention and mobile app

Interventions

Remote dietitian supervised weight loss intervention and mobile app BEHAVIORAL

Please see intervention arm description for more details.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age \>= 18 years of age
• BMI \> 40 kg/m2 at study enrollment
• \. End-stage knee or hip osteoarthritis, avascular necrosis, or rheumatoid arthritis with recommended primary, unilateral total joint arthroplasty by orthopaedic surgeons at Brigham and Women's Hospital or Mass General Hospital (e.g. Dr. Antonia Chen, Dr. Jeffrey Lange, Dr. Vivek Shah, Dr. Richard Iorio and Dr. Wolfgang Fitz).
• Subject would consider undergoing a total joint arthroplasty if eligible.
• Owns a smartphone compatible with video calls and Nutrimedy (i.e. has access to Apple App Store or Google Play to download app) or has home internet access and a webcam for video calls.
• All subjects must be willing to comply with the requirements of the study and provide informed consent prior to enrollment. Evidence of a signed (by the research staff obtaining verbal consent) and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study must be obtained before data collection.

You may not qualify if:

• BMI\>47 kg/m2 at study enrollment (BMI over 47 kg/ m2 would require inappropriate weight loss of over 3 lbs per week to reach a BMI of 40 kg/m2 after 12 weeks).
• Subjects unable to comprehend and speak English
• Subjects requiring a revision total joint arthroplasty
• Subjects undergoing bilateral total joint arthroplasty
• Subjects planning to undergo bariatric weight loss surgery in the next 6 months.
• Subjects planning to be pregnant in the next 6 months
• Subjects unwilling or unable to use a hand-held smartphone or personal computer with home internet access
• Incarcerated subjects
• Pregnant women and vulnerable individuals

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Vela Foundation: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (6)

• Warner DO. Surgery as a teachable moment: lost opportunities to improve public health. Arch Surg. 2009 Dec;144(12):1106-7. doi: 10.1001/archsurg.2009.205. No abstract available.

  PMID: 20026826 BACKGROUND

• McElroy MJ, Pivec R, Issa K, Harwin SF, Mont MA. The effects of obesity and morbid obesity on outcomes in TKA. J Knee Surg. 2013 Apr;26(2):83-8. doi: 10.1055/s-0033-1341407. Epub 2013 Mar 11.

  PMID: 23479424 BACKGROUND

• Gandler N, Simmance N, Keenan J, Choong PF, Dowsey MM. A pilot study investigating dietetic weight loss interventions and 12 month functional outcomes of patients undergoing total joint replacement. Obes Res Clin Pract. 2016 Mar-Apr;10(2):220-3. doi: 10.1016/j.orcp.2016.03.006. Epub 2016 Apr 3.

  PMID: 27053573 BACKGROUND

• Liljensoe A, Laursen JO, Bliddal H, Soballe K, Mechlenburg I. Weight Loss Intervention Before Total Knee Replacement: A 12-Month Randomized Controlled Trial. Scand J Surg. 2021 Mar;110(1):3-12. doi: 10.1177/1457496919883812. Epub 2019 Nov 3.

  PMID: 31679465 BACKGROUND

• Pellegrini CA, Chang RW, Dunlop DD, Conroy DE, Lee J, Van Horn L, Spring B, Cameron KA. Comparison of a Patient-Centered Weight Loss Program starting before versus after knee replacement: A pilot study. Obes Res Clin Pract. 2018 Sep-Oct;12(5):472-478. doi: 10.1016/j.orcp.2018.06.009. Epub 2018 Jul 11.

  PMID: 30007535 BACKGROUND

• Seward MW, Antonelli BJ, Giunta N, Iorio R, Fitz W, Lange JK, Shah VM, Chen AF. Weight loss before total joint arthroplasty using a remote dietitian and mobile app: study protocol for a multicenter randomized, controlled trial. J Orthop Surg Res. 2020 Nov 13;15(1):531. doi: 10.1186/s13018-020-02059-w.

  PMID: 33187535 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonia F Chen, MD, MBA

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to the intervention or control group. The Principal Investigator and staff recording outcome measures (e.g. weighing patients) will be blinded to participant assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery

Model Details: Two group randomized control trial comparing the intervention and standard care.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)