UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059930 |
|---|---|
| Receipt number | R000066042 |
| Scientific Title | Implementation research of an intervention for mothers to improve obesity in adults with severe intellectual disabilities |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/12/01 12:45:33 |
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Basic information
Public title
Implementation research of an intervention for mothers to improve obesity in adults with severe intellectual disabilities
Acronym
Implementation research of an intervention for obesity in adults with severe intellectual disabilities
Scientific Title
Implementation research of an intervention for mothers to improve obesity in adults with severe intellectual disabilities
Scientific Title:Acronym
Implementation research of an intervention for obesity in adults with severe intellectual disabilities
Region
| Japan |
Condition
Condition
Intellectual disability
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify the weight loss effects of a weight loss program developed by the researchers and confirmed to be effective by nurses and other professionals at facilities for people with intellectual disabilities in Aichi Prefecture, and to clarify the challenges in implementing the program nationwide at day care facilities. The study will also propose improvements to address these challenges.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Weight
Key secondary outcomes
Number of failed days and the scores of the children's inflexible adherence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nurses or other healthcare professionals will intervene with mothers of individuals with severe intellectual disabilities following the program checklist and text. The intervention period is 7.5 months and will be conducted according to the following schedule: Research Session 1, weight measurement one week later, Research Session 2 two weeks later as the baseline, monthly interviews over four months, and a three-month follow-up period after the intervention.
First, nurses or other healthcare professionals conduct two 90-minute training sessions using text and explanatory videos on the process of accepting obesity in mothers and behavioral analysis to help mothers decide on target foods that will not cause conflict with their children.
Following this, mothers will implement changes to the target foods they decided on at home, record their children's reactions, the amount of target foods consumed, and their weight. Nurses or other staff will conduct 30-minute interviews monthly over the 4-month period, praising mothers' efforts, comparing them to weight loss predictions, and providing support to overcome obstacles.
During the month between interviews, nurses or other staff will provide support to mothers via phone twice.
Three months after the intervention ends, a follow-up interview is conducted to praise the achievements made, compare them with weight loss predictions, provide support to overcome obstacles, and confirm future goals.
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
Certification of severe ID (holds an A-level ID certificate in Japan), BMI of 25 or higher, residing with family at home, and Mother's age 75 years or younger.
Key exclusion criteria
Receiving dietary guidance from experts within the last 6 months and those deemed inappropriate for participating in the study by facility staff.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mitsuyo |
| Middle name | |
| Last name | Nonaka |
Organization
NIHON FUKUSHI UNIVERSITY
Division name
Department of Nursing
Zip code
477-0031
Address
1071 Shimohamada, Ota-machi, Tokai-shi, Aichi, Japan
TEL
0562-39-3811
1minonaka@gmail.com
Public contact
Name of contact person
| 1st name | Mitsuyuo |
| Middle name | |
| Last name | Nonaka |
Organization
NIHON FUKUSHI UNIVERSITY
Division name
Department of Nursing
Zip code
477-0031
Address
1071 Shimohamada, Ota-machi, Tokai-shi, Aichi, Japan
TEL
0562-39-3811
Homepage URL
1minonaka@gmail.com
Sponsor or person
Institute
NIHON FUKUSHI UNIVERSITY
Institute
Department
Personal name
Mitsuyo Nonaka
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Aichi Prefectural University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Research Involving Human Subjects, Nihon Fukushi University
Address
1071 Shimohamada, Ota-machi, Tokai-shi, Aichi, Japan
Tel
0562-39-3811
rinri@ml.n-fukushi.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
| 2025 | Year | 12 | Month | 01 | 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
| 2025 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066042
