UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054866 |
|---|---|
| Receipt number | R000062690 |
| Scientific Title | Effects of low versus moderate-to-high intensity weight management on knee replacements: A targeted learning and emulated trials-based approach |
| Date of disclosure of the study information | 2024/07/03 |
| Last modified on | 2024/12/06 09:18:51 |
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Basic information
Public title
Effects of low versus moderate-to-high intensity weight management on knee replacements: A targeted learning and emulated trials-based approach
Acronym
Effects of low versus moderate-to-high intensity weight management on knee replacements: A targeted learning and emulated trials-based approach
Scientific Title
Effects of low versus moderate-to-high intensity weight management on knee replacements: A targeted learning and emulated trials-based approach
Scientific Title:Acronym
Effects of low versus moderate-to-high intensity weight management on knee replacements: A targeted learning and emulated trials-based approach
Region
| Japan |
Condition
Condition
Patients at a higher risk for knee OA or those with symptomatic knee OA
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the efficacy of a biennial weight management in reducing the necessity for knee replacement (KR) surgery among middle-aged and older adults with or at a higher risk for knee osteoarthritis (OA) using an emulated-trials based approach.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The present study outcome is an incident knee replacement (either total or partial) recorded in the OAI through medical reports or radiographic adjudication, with a follow-up period of 96 months after baseline assessment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 45 to 79 years at a higher risk for knee OA or those with symptomatic knee OA
Key exclusion criteria
None
Target sample size
4796
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Ikeda |
Organization
Yamagata University
Division name
Department of Health Policy Science
Zip code
9909585
Address
2-2-2, Iidanishi, Yamagata City, Yamagata
TEL
0236285932
tikeda@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Ikeda |
Organization
Yamagata University
Division name
Department of Health Policy Science
Zip code
9909585
Address
2-2-2 Iidanishi, Yamagata, Yamagata
TEL
0236285932
Homepage URL
tikeda@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of California
Address
1111 Franklin Street Oakland, CA 94607
Tel
+1 510-642-6000
ucinfo@ucapplication.net
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
https://nda.nih.gov/oai/about-oai
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/aje/advance-article-abstract/doi/10.1093/aje/kwae446/7912633?redirectedFrom
Number of participants that the trial has enrolled
4796
Results
This study, involving 4,796 patients, revealed that targeted weight management significantly affected KR incidence. Specifically, a 12.5% reduction in body mass index (BMI) (high-intensity program) resulted in a notable decrease in KR rates, from 6.11% [95% confidence interval (CI), 5.80 to 6.43] in the baseline maintenance regimen (low-intensity program) to 3.95% (95% CI, 2.94 to 4.96) in the high intensity program, effectively preventing 207 KRs over 96 months.
Results date posted
| 2024 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 4,796 patients (9,592 knees) (Figure 3), with an average age of 61.2 years (standard deviation: 9.2 years), 58.5% were women, and 38.5% had a K/L grade of 0.
Participant flow
N/A
Adverse events
None
Outcome measures
The present study exposure was BMI (continuous) measured after 12 and 24 months from baseline assessment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2002 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2004 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 02 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 03 | Day |
Other
Other related information
This cohort study used data from the Osteoarthritis Initiative cohort in the US, consisting of community-dwelling adults aged 45 to 79 years at high risk for or with symptomatic knee OA, who underwent baseline assessments from September 2008 to December 2010. Subsequent evaluations were conducted at 12, 24, and 96 months. A biennial weight management initiative, ranging from low to moderate-to-high intensity, was employed as the exposure variable, while the incidence of knee replacement during the follow-up periods served as the outcome.
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062690
