UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048636 |
|---|---|
| Receipt number | R000055415 |
| Scientific Title | Relationship between Autonomous Motivation for Dietary Self-Care Activities and Quality of Life in People with Type 2 Diabetes |
| Date of disclosure of the study information | 2022/08/09 |
| Last modified on | 2025/02/10 11:56:25 |
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Basic information
Public title
Relationship between Autonomous Motivation for Dietary Self-Care Activities and Quality of Life in People with Type 2 Diabetes
Acronym
Relationship between Autonomous Motivation for Dietary Self-Care Activities and Quality of Life in People with Type 2 Diabetes
Scientific Title
Relationship between Autonomous Motivation for Dietary Self-Care Activities and Quality of Life in People with Type 2 Diabetes
Scientific Title:Acronym
Relationship between Autonomous Motivation for Dietary Self-Care Activities and Quality of Life in People with Type 2 Diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the relationship between autonomous motivation for dietary self-care activities and Quality of Life in people with type 2 diabetes
Basic objectives2
Others
Basic objectives -Others
Quality of Life in people with type 2 diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Japanese version of the Audit
of Diabetes-Dependent Quality of Life 19 (JP-ADDQoL19)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with type 2 diabetes
2)Patients aged 18 and over
3)Individuals who are able to read and write Japanese
Key exclusion criteria
1)Patients who are less than 3 months since diagnosis
2)Patients diagnosed with cognitive impairment and/or psychiatric disorder
3)Patients who are ineligible for the study participation based on the doctor's judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Nin |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
606-8507
Address
53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3946
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Morinishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
606-8507
Address
53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3947
Homepage URL
morinishi.kanako.4n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2022 | Year | 08 | Month | 09 | 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
236
Results
Results showed that autonomous motivation for dietary self-care activities was related to overall QOL through competence for and/or implementation levels of dietary self-care activities but not to diabetes-dependent QOL. There was no direct impact from autonomous motivation on QOL.
Results date posted
| 2025 | Year | 02 | Month | 10 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Paper is under review.
Date of the first journal publication of results
Baseline Characteristics
The mean HbA1c was 7.5% (58.7 mmol/mol), and 73.1% of the participants did not receive insulin therapy.
Participant flow
A total of 236 individuals agreed to participate. Of these, 235 responded to the questionnaires (response rate: 99.6%). Four respondents with inappropriate response styles and seven respondents with incomplete questionnaire were excluded from the analysis because the missing values were regarded as missing completely at random. Finally, data from 223 individuals were analyzed (effective response rate: 94.5%).
Adverse events
No adverse events were observed.
Outcome measures
This study tested a hypothetical model based on these hypotheses.
(1) Autonomous motivation for dietary self-care behaviors positively affects QOL without a mediating role of competence or implementation levels.
(2) Autonomous motivation for dietary self-care behaviors positively affects QOL through competence without a mediating role of implementation levels.
(3) Autonomous motivation for dietary self-care behaviors positively affects QOL through implementation levels without a mediating role of competence.
(4) Autonomous motivation for dietary self-care behaviors positively affects QOL by first enhancing competence and, subsequently, implementation levels.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 17 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 18 | Day |
Date analysis concluded
Other
Other related information
questionary investigation
Management information
Registered date
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055415
