UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062659 |
|---|---|
| Receipt number | R000071727 |
| Scientific Title | Effect of Intensive Behavioral Intervention on Weight-Loss Maintenance After Discontinuation of Incretin-Based Anti-Obesity Therapy: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/22 18:29:28 |
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Basic information
Public title
Effect of Intensive Behavioral Intervention on Weight-Loss Maintenance After Discontinuation of Incretin-Based Anti-Obesity Therapy: A Multicenter Randomized Controlled Trial
Acronym
WMID trial
Weight-loss Maintenance after Incretin Discontinuation
Scientific Title
Effect of Intensive Behavioral Intervention on Weight-Loss Maintenance After Discontinuation of Incretin-Based Anti-Obesity Therapy: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
WMID trial
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether intensive behavioral intervention, compared with standard lifestyle counseling, reduces weight regain and improves weight-loss maintenance after discontinuation of incretin-based anti-obesity therapy in patients with obesity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage weight regain from discontinuation of incretin based antiobesity therapy to 12 months after discontinuation.
Percentage weight regain will be calculated as: ((body weight at 12 months after discontinuation - body weight at discontinuation)/body weight at discontinuation) times 100 (%).
Key secondary outcomes
1. Percentage of weight lost during incretin-based anti-obesity therapy that is regained at 12 months after discontinuation.
2. Proportion of participants with >=5% weight regain from body weight at discontinuation at 12 months after discontinuation.
3. Proportion of participants who regain >=25% and >=50% of the weight lost during incretin-based anti-obesity therapy at 12 months after discontinuation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intensive behavioral intervention group: Participants will receive outpatient follow-up and nutritional counseling every 4 weeks for 12 months after discontinuation of incretin-based anti-obesity therapy. In addition to standard nutritional and lifestyle counseling, the intensive behavioral intervention will include self-weighing, self-monitoring of dietary intake and physical activity, individualized goal setting, assessment and feedback on goal attainment, problem-solving support, and behavioral plan adjustment in response to weight regain.
Interventions/Control_2
Standard intervention group: Participants will receive outpatient follow-up every 4 weeks for 12 months after discontinuation of incretin-based anti-obesity therapy.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 20 to 75 years.
2. Patients with obesity who have received anti-obesity treatment with semaglutide or tirzepatide for at least 52 weeks.
3. Patients who have achieved a body weight reduction of >=5% from initiation to discontinuation of anti-obesity therapy.
4. Patients who are scheduled to discontinue semaglutide or tirzepatide upon completion of the planned treatment period.
5. Patients for whom body weight at initiation and discontinuation of anti-obesity therapy is available.
6. Patients who provide written informed consent to participate in the study.
Key exclusion criteria
1. Pregnant or breastfeeding women, or women planning pregnancy during the study period.
2. Patients who are scheduled to initiate or use medications expected to substantially affect body weight, including other anti-obesity medications, during the study period.
3. Patients planning bariatric surgery or other invasive weight-loss procedures during the study period.
4. Patients with severe cardiac, hepatic, renal, malignant, or other serious diseases that, in the investigator's judgment, would interfere with participation in the study or completion of the 12-month follow-up.
6. Patients with psychiatric disorders or cognitive impairment that may substantially interfere with adherence to or assessment of the study intervention.
7. Patients considered unsuitable for participation in the study by the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shinkomonji Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu, Japan
TEL
+81-80-83513029
k-tetsuy@med.uoeh.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Oniyama |
Organization
Shinkomonji Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu, Japan
TEL
+81-93-3911001
Homepage URL
dpvdtrial@mbox.med.uoeh-u.ac.jp
Sponsor or person
Institute
Shinkomonji Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi Endocrine Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinkomonji Hospital
Address
2-5 Dairishinmachi, Moji, Kitakyushu, Japan
Tel
+81-93-3911001
dpvdtrial@mbox.med.uoeh-u.ac.jp
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
| 2026 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 22 | Day |
Last modified on
| 2026 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071727
