Arthroplasties, ReplacementNCT04330391
Weight Loss Before Total Joint Arthroplasty Using A Remote Dietitian and Mobile App
A study testing Remote dietitian supervised weight loss intervention and mobile app in people with Arthroplasties, Replacement and Weight Loss, run by Brigham and Women's Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasties, Replacement, Weight Loss, Nutrition
- What is being tested?
- Remote dietitian supervised weight loss intervention and mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects age >= 18 years of age
- BMI > 40 kg/m2 at study enrollment
- 3. 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.
Who cannot join
- 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
Show all 9Show fewer
- Subjects unwilling or unable to use a hand-held smartphone or personal computer with home internet access
- Incarcerated subjects
- Pregnant women and vulnerable individuals
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Faulkner Hospital
Boston, Massachusetts, 02130
About this study
Official title: Implementing Weight Loss Before Total Joint Arthroplasty Using A Remote Dietitian and Mobile App: A Randomized, Control Trial
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.
Read the detailed description
Recruitment: Patients of orthopaedic surgeons (e.g. Dr. Antonia Chen, Dr. Jeffrey Lange, Dr. Vivek Shah, Dr. Richard Iorio and Dr. Wolfgang Fitz) at the Brigham and Women's Hospital or Mass General Hospital orthopaedic clinics will be identified as potentially eligible for the study based on 1) 40 < body mass index (BMI) < 47 kg/m2 in the last 6 months recorded in the Partners electronic medical record, and 2) recommended unilateral total joint arthroplasty. Study flyers will be posted in MGH orthopedics clinics to remind clinicians that their patients may be eligible for the study, or patients may directly contact the research team by emailing the contact person on the flyer. For patients identified as potentially eligible while in clinic, an orthopaedic surgeon will introduce the patient to the study, and a member of the research team (research assistant or trainee) will conduct an eligibility screening (see eligibility criteria above) and obtain verbal consent either in-person or by phone. For patients identified as potentially eligible outside of clinic, a member of the research team will call the patient to introduce the study, and conduct eligibility screening and consent on the phone. Research staff may also contact these patients by email or via Patient Gateway to help coordinate a time convenient for staff to call the patient.
Interested, eligible, and consented subjects will be provisionally enrolled and each subject (both intervention and standard care participants) will be shipped a standard bathroom scale that they will keep even after the study concludes. Subjects will be asked to verify their enrollment BMI is 40 < body mass index (BMI) < 47 kg/m2. Subjects can verify weights by either a) submitting a photo to the study team of the home scale during a weigh-in that displays their body weight, or by b) recording a baseline weight at a Partners facility. For option a) subjects will submit a photo of their weight displayed on the scale to the study team either by email to a study team member's Partners email address, through the mobile app, or via RedCap. Subjects who are not able to confirm their enrollment BMI is within this range will be removed from the study. Subjects who can confirm their enrollment BMI is within this range will then be randomized to a trial arm.
Arms: Intervention participants will download the Nutrimedy telemedicine online/smartphone app and be connected at enrollment with a certified 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. Intervention participants will additionally be asked if they would be interested in completing a brief 5-minute interview in-person or by phone at the end of the study (10-14 weeks after enrollment) to discuss qualitative feedback about the intervention. Responses will be transcribed verbatim during the interview for later analysis.
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).
- Conditions
- Arthroplasties, Replacement, Weight Loss, Nutrition
- Being tested
- Remote dietitian supervised weight loss intervention and mobile app
- Keywords
- Arthroplasty, Weight loss, Health coach, dietitian
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote dietitian supervised weight loss intervention and mobile appBehavioural
Please see intervention arm description for more details.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Remote dietitian supervised weight loss intervention and mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Patients are deemed eligible to undergo TJA if they have a BMI under 40 kg/m2. Weights will be recorded as described in Outcome 1.
Measured: This outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.
Percentage of patients undergoing total joint arthroplasty (TJA)
Undergoing TJA will be assessed by checking participant online medical records for TJA surgery dates.
Measured: This outcome will be evaluated for each subject at 6 months after study enrollment.
Number of completed video call sessions with dietitian
Number of calls completed with a dietitian will be assessed for intervention subjects.
Measured: This outcome will be assessed 14 weeks after enrollment.
Change from baseline in Paving Wheel Wellness score
Baseline and end-of-study surveys will assess behavioral, physical activity, and functional outcomes. The Paving Wheel Wellness score is calculated based on survey responses to these elements. The score ranges from 16 to 80, and a higher score indicates a better outcome.
Measured: Baseline surveys are completed at enrollment. End-of-study surveys are assessed at 10-14 weeks after enrollment.
Change from baseline in HbA1c
The following blood serology labs will be assessed at baseline and end-of-study: HbA1c, serum albumin, transferrin, total lymphocyte count. These labs have been recommended to assess malnutrition in orthopaedic patients.
Measured: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Change from baseline in serum albumin
The following blood serology labs will be assessed at baseline and end-of-study: HbA1c, serum albumin, transferrin, total lymphocyte count. These labs have been recommended to assess malnutrition in orthopaedic patients.
Measured: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Change from baseline in transferrin
The following blood serology labs will be assessed at baseline and end-of-study: HbA1c, serum albumin, transferrin, total lymphocyte count. These labs have been recommended to assess malnutrition in orthopaedic patients.
Measured: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Change from baseline in total lymphocyte count
The following blood serology labs will be assessed at baseline and end-of-study: HbA1c, serum albumin, transferrin, total lymphocyte count. These labs have been recommended to assess malnutrition in orthopaedic patients.
Measured: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Jul 2020
- Primary completion1 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arthroplasties, ReplacementStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomized control trial comparing the intervention and standard care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vela Foundation
- Responsible party
- Principal investigator, Antonia Faustina Chen, Brigham and Women's Hospital
- Investigators
- Antonia F Chen, MD, MBA, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330391
- Sponsor's protocol ID
- 2020P000322
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2020
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Statistics based on aggregated information will be published, but those statistics will not contain any Personally Identifiable Information.
Publications
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.
PubMed 20026826McElroy 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.
PubMed 23479424Gandler 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.
PubMed 27053573Liljensoe 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.
PubMed 31679465Pellegrini 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.
PubMed 30007535Seward 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.
PubMed 33187535
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Weight Loss Before Total Joint Arthroplasty Using A Remote Dietitian and Mobile App: A Randomized, Control Trial
- ClinicalTrials.gov ID
- NCT04330391
- Acronym / sponsor ID
- 2020P000322
- Conditions
- Arthroplasties, Replacement, Weight Loss, Nutrition
- Keywords
- Arthroplasty, Weight loss, Health coach, dietitian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Vela Foundation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recruitment: Patients of orthopaedic surgeons (e.g. Dr. Antonia Chen, Dr. Jeffrey Lange, Dr. Vivek Shah, Dr. Richard Iorio and Dr. Wolfgang Fitz) at the Brigham and Women's Hospital or Mass General Hospital orthopaedic clinics will be identified as potentially eligible for the study based on 1) 40 < body mass index (BMI) < 47 kg/m2 in the last 6 months recorded in the Partners electronic medical record, and 2) recommended unilateral total joint arthroplasty. Study flyers will be posted in MGH orthopedics clinics to remind clinicians that their patients may be eligible for the study, or patients may directly contact the research team by emailing the contact person on the flyer. For patients identified as potentially eligible while in clinic, an orthopaedic surgeon will introduce the patient to the study, and a member of the research team (research assistant or trainee) will conduct an eligibility screening (see eligibility criteria above) and obtain verbal consent either in-person or by phone. For patients identified as potentially eligible outside of clinic, a member of the research team will call the patient to introduce the study, and conduct eligibility screening and consent on the phone. Research staff may also contact these patients by email or via Patient Gateway to help coordinate a time convenient for staff to call the patient.
Interested, eligible, and consented subjects will be provisionally enrolled and each subject (both intervention and standard care participants) will be shipped a standard bathroom scale that they will keep even after the study concludes. Subjects will be asked to verify their enrollment BMI is 40 < body mass index (BMI) < 47 kg/m2. Subjects can verify weights by either a) submitting a photo to the study team of the home scale during a weigh-in that displays their body weight, or by b) recording a baseline weight at a Partners facility. For option a) subjects will submit a photo of their weight displayed on the scale to the study team either by email to a study team member's Partners email address, through the mobile app, or via RedCap. Subjects who are not able to confirm their enrollment BMI is within this range will be removed from the study. Subjects who can confirm their enrollment BMI is within this range will then be randomized to a trial arm.
Arms: Intervention participants will download the Nutrimedy telemedicine online/smartphone app and be connected at enrollment with a certified 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. Intervention participants will additionally be asked if they would be interested in completing a brief 5-minute interview in-person or by phone at the end of the study (10-14 weeks after enrollment) to discuss qualitative feedback about the intervention. Responses will be transcribed verbatim during the interview for later analysis.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group randomized control trial comparing the intervention and standard care.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Remote dietitian supervised weight loss intervention and mobile appIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects age >= 18 years of age
- BMI > 40 kg/m2 at study enrollment
- 3. 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote dietitian supervised weight loss intervention and mobile appPlease see intervention arm description for more details. | Behavioural | Intervention |
Primary outcome
Percentage of weight lost or gained from baseline
Time frame: Final weights will be recorded at 12 weeks (10-14 weeks) after study enrollment. The baseline weight will be recorded at enrollment.
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.
8 secondary outcomes
Percentage of patients eligible to undergo total joint arthroplasty (TJA)
Time frame: This outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.
Percentage of patients undergoing total joint arthroplasty (TJA)
Time frame: This outcome will be evaluated for each subject at 6 months after study enrollment.
Number of completed video call sessions with dietitian
Time frame: This outcome will be assessed 14 weeks after enrollment.
Change from baseline in Paving Wheel Wellness score
Time frame: Baseline surveys are completed at enrollment. End-of-study surveys are assessed at 10-14 weeks after enrollment.
Change from baseline in HbA1c
Time frame: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Change from baseline in serum albumin
Time frame: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Change from baseline in transferrin
Time frame: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Change from baseline in total lymphocyte count
Time frame: Baseline labs will be collected within 2 weeks of enrollment. End-of-study labs will be collected 10-14 weeks after enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 20026826Warner 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.
- Background: PubMed 23479424McElroy 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.
- Background: PubMed 27053573Gandler 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.
- Background: PubMed 31679465Liljensoe 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.
- Background: PubMed 30007535Pellegrini 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.
- Derived from this study: PubMed 33187535Seward 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Statistics based on aggregated information will be published, but those statistics will not contain any Personally Identifiable Information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia F Chen, MD, MBA principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote dietitian supervised weight loss intervention and mobile app in people with Arthroplasties, Replacement and Weight Loss, run by Brigham and Women's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of weight lost or gained from baseline (time frame: Final weights will be recorded at 12 weeks (10-14 weeks) after study enrollment. The baseline weight will be recorded at enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330391, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.