UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058717 |
|---|---|
| Receipt number | R000066356 |
| Scientific Title | A Theory-Based Single-Session Behavior Change Intervention for Adults at Risk of Metabolic Syndrome: Evaluating a DualPhase Dual-Process Approach |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/06 18:43:50 |
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Basic information
Public title
An Evaluation Study on the Effectiveness of Motivational Support Based on the Dual-Phase Dual-Process Approach
Acronym
Evaluating a New Health Guidance Program Focusing on Tips for Sustained Behavior Change
Scientific Title
A Theory-Based Single-Session Behavior Change Intervention for Adults at Risk of Metabolic Syndrome: Evaluating a DualPhase Dual-Process Approach
Scientific Title:Acronym
DPDP-SSI Study
Region
| Japan |
Condition
Condition
Individuals Eligible for Motivational Support under the Specified Health Guidance Program
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This project examines the effectiveness of a single-session intervention based on the Dual-Phase Dual-Process (DPDP) approach, targeting adults at risk of metabolic syndrome. It integrates theoretical elements from Mental Contrasting with Implementation Intentions (MCII) and the Reflective-Impulsive Model (RIM) to promote behavior change in dietary and physical activity habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Goal attainment for behavior change (dietary and physical activity goals): Self-reported binary outcome (achieved / not achieved), assessed at three-month follow-up
Key secondary outcomes
- Waist circumference (cm): Measured at baseline and three-month follow-up, based on official health checkup records.
- Body weight (kg): Measured at baseline and three-month follow-up, based on official health checkup records.
- Behavioral Inhibition System (BIS) and Behavioral Activation System (BAS) scores: Pre-post measurement (DPDP group only) using the validated Japanese version of the BIS/BAS scale. Subscales include:
- BIS
- BAS Drive (BAS-D)
- BAS Reward Responsiveness (BAS-R)
- BAS Fun Seeking (BAS-F)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
an intervention group who received motivational health guidance based on the Dual-Phase Dual-Process (DPDP) approach in the current fiscal year
Interventions/Control_2
a comparison group who received standard motivational health guidance in the previous fiscal year
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
+Individuals enrolled in the National Health Insurance of the relevant municipality
+Individuals who have been identified as eligible for "Motivational Support" under Japan's Specified Health Guidance program
+Individuals who expressed willingness to participate in Motivational Support in response to the municipal guidance notification
+Individuals who are expected to set behavior change goals related to dietary and physical activity habits
+Individuals who are able to receive and understand health guidance in Japanese
Key exclusion criteria
+unable to participate in or understand the guidance conducted in Japanese
+judged by the principal investigator to have difficulty understanding or implementing the content of the guidance
+decline to participate in the intervention
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | OGATA |
Organization
Institute of SCIENCE TOKYO
Division name
Graduate School of Health Care Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5730
yogata.gh@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | SATO |
Organization
Institute of SCIENCE TOKYO
Division name
Graduate School of Health Care Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5730
Homepage URL
https://osf.io/4fw3z
sato.j.4647@m.isct.ac.jp
Sponsor or person
Institute
Institute of SCIENCE TOKYO
Institute
Department
Personal name
SATO Jun
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.adm@tmd.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
愛知県蒲郡市、千葉県勝浦市
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
We accept registrations only when submitted directly by the relevant municipality
Management information
Registered date
| 2025 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066356
