UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047478 |
|---|---|
| Receipt number | R000054146 |
| Scientific Title | Effect of a weight-loss intervention by mothers for adults with severe intellectual disability: A cluster randomized controlled trial |
| Date of disclosure of the study information | 2022/04/19 |
| Last modified on | 2025/03/09 19:08:41 |
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Basic information
Public title
Effect of a weight-loss intervention by mothers for adults with severe intellectual disability: A cluster randomized controlled trial
Acronym
Effect of a weight-loss intervention by mothers for adults with severe intellectual disability: A cluster randomized controlled trial
Scientific Title
Effect of a weight-loss intervention by mothers for adults with severe intellectual disability: A cluster randomized controlled trial
Scientific Title:Acronym
Effect of a weight-loss intervention by mothers for adults with severe intellectual disability: A cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Severe intellectual disability
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether Conflict-free Weight-loss program, which is conducted by day center nurses and dietitians for mothers, is effective for adults with severe intellectual disabilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight and waist circumference
(Once a month for 4 months from the start of the intervention and once 3 months after the end of the intervention)
Key secondary outcomes
Target foods intake, inflexible adherence score (0 = as usual; 10 = occurrence of problem behavior), and occurrence of desirable maternal behavior.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: (4 months + follow-up 3months)
1. Training on intervention methods for mothers from the researcher to the nurses or dietitians of the day center where the intervention will be conducted (2hours, 1session)
2. Programs for mothers by nurses or dietitians (4 months).
1) Education1 (70-90 minutes), Education2 (70-90 minutes)
2) Face-to-face consultation (once a month for 4 months, 60 minutes)
3) Consultation by talk or telephone (twice a month)
4) Self-monitoring
Interventions/Control_2
Control group: (4 months + follow-up 3months)
Usual care at each day center
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)Certification of severe intellectual disability
2)BMI 25 or more
3)Residing with family at home (including short-stay users up to 2 nights a week)
Key exclusion criteria
1) Those who have participated in this program before.
2)Mothers over 76 years old
3)Receiving dietary guidance from experts within the last 6 months
4)Those who are deemed by the day center staff to be too difficult to participate in this program.
Target sample size
40
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, Faculty of Nursing
Zip code
477-0031
Address
1071 Simohamada, Ota-machi, Tokai-shi, Aichi, Japan
TEL
0562-39-3811
1minonaka@gmail.com
Public contact
Name of contact person
| 1st name | Mitsuyo |
| Middle name | |
| Last name | Nonaka |
Organization
Nihon Fukushi University
Division name
Department of Nursing, Faculty 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
Funding Source
Organization
The Japan Society for the Promotion of Science.
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
Nagoya Women's University
Address
3-40, Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-852-1111
somu@nagoya-wu.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 | 04 | Month | 19 | Day |
Related information
URL releasing protocol
https://doi.org/10.1371/journal.pone.0315578
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0315578
Number of participants that the trial has enrolled
31
Results
15 adults in the intervention group and 13 in the control group completed the follow-up. The intervention group showed significantly reduced weight (median; baseline 1, post-intervention 0.975, follow-up 0.983, p < 0.001), and slightly reduced waist circumference (median; baseline 1, post-intervention 0.975, follow-up 0.975, p = 0.226); however, the control group showed no change. Adults' resistance was minimal, maternal implementations were high, and daily food intake decreased.
Results date posted
| 2025 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 04 | Day |
Baseline Characteristics
The median age of the participants was 31.5 years (range:20-48 years); 18 (64.3%) were male, and the median age of their mothers was 61.5 years (range: 45-75 years). Their median weight was 76.0 kg (range: 50.6-118.5 kg), median BMI was 30.4 kg/m2 (range: 25.7-54.0 kg/m2), and median waist circumference was 103.4 cm (range: 83.0-133.4 cm). Regarding diagnoses, six (21.1%) had severe intellectual disability, 13 (46.4%) had autism only comorbid, one (3.6%) had autism and Down syndrome comorbid, and 4 (14.3%) had Down syndrome complications. No significant differences were observed between the two groups at baseline. One participant in the control group required ambulatory support and occasionally used a wheelchair. Most of the professionals were nurses (n=13, 76.4%).
Participant flow
A total of 31 pairs of mothers and adults with severe ID (including 16 with autism) and 19 nurses and dietitians, from 17 day centers agreed to participate in the study, and 28 pairs of mothers and adults with severe ID and 17 nurses and dietitians from 15 day centers completed the follow-up. The number of participants per day center was 1-3 pairs. Reasons for dropout were nursing burden, leaving the day center, and long-term institutionalization.
Adverse events
No adverse events attributable to the intervention occurred.
Outcome measures
Primary outcomes included the adults' weight and waist circumference. The secondary outcomes were mothers' implementation, adults' scores for inflexible adherence, and daily intake of target food.
Plan to share IPD
IPD sharing Plan description
Recruitment began in May 2022 and ended in April 2023 when there were no more inquiries from facilities of the Aichi Prefecture Association on ID to participate in the study. Data were collected from June 2022 until December 2023. Primary outcomes (weight and waist circumference) were measured by nurses or dietitians who delivered the intervention. Weight (kg) and waist circumference (cm) were measured weekly during a 2-week baseline, monthly during the 4-month intervention, and once 3 months after the intervention. Height was used as the most recent height known by the facility, including physical examinations. Secondary outcomes were target food intake, the adult's score of inflexible adherence, and whether the mother implemented the intervention, which was recorded at home by the mother. As a confounding factor, on the first day of the baseline, the last day of the intervention period, and the last day of the follow-up, experts at the facility, such as nurses, asked mothers to complete a record of the meals eaten during the most recent weekday, and then asked whether there was a change in meals other than the target food and physical activity. The mothers' records and the experts' result sheets were copied by the expert and mailed to the researcher, either in a self-addressed envelope or emailed as a file attachment. In the intervention group, after seven and a half months of data collection, feedback on the program from nurses and mothers was obtained by the researcher, either in person or by telephone.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 13 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054146
