UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054203 |
|---|---|
| Receipt number | R000061484 |
| Scientific Title | A Randomized Controlled Trial of the Effect of a Text Message Intervention on Obesity Improvement in Adult Male Workers Under Age 40 (Pilot Study) |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/19 18:40:29 |
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Basic information
Public title
A Randomized Controlled Trial of the Effect of a Text Message Intervention on Obesity Improvement in Adult Male Workers Under Age 40 (Pilot Study)
Acronym
A Randomized Controlled Trial of the Effect of a Text Message Intervention on Obesity Improvement in Adult Male Workers Under Age 40 (Pilot Study)
Scientific Title
A Randomized Controlled Trial of the Effect of a Text Message Intervention on Obesity Improvement in Adult Male Workers Under Age 40 (Pilot Study)
Scientific Title:Acronym
A Randomized Controlled Trial of the Effect of a Text Message Intervention on Obesity Improvement in Adult Male Workers Under Age 40 (Pilot Study)
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Main objectives: (1) To assess the preliminary effectiveness of the intervention in the study population. (2) Determine the appropriateness of the intervention modality and duration of implementation from reach and drop-out rates. (3) To assess the acceptability of text messages. Secondary objectives: to calculate effect sizes and collect data for power analysis to establish the sample size required for a full-scale Randomised Controlled Trial (RCT) of lifestyle self-management in the study population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the effectiveness of the intervention. Percentage of weight loss achieved at the time of evaluation from baseline. Weight loss attainment should be targeted at 3% of body weight.
Key secondary outcomes
1)Baseline, 3 months later: BMI, abdominal circumference, Weight Efficacy Life-Style Questionnaire, New General Self-Efficacy Scale Japanese version : NGSE-J, Stages of Change regarding lifestyle improvement initiatives Change
2)Three months later: intervention group only.
Study subjects are asked to rate their satisfaction, utilisation and recommendation to others on a five-point scale and an open-ended questionnaire. Frequency, timing and duration of message delivery will be assessed.
3) At baseline, one month, two months and three months
Evaluate the SMS reachability rate and URL click rate from the SMS platform and the number of accesses from the research website.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group - at the start, knowledge about obesity and lifestyle modification is provided by brochures; health guidance for obesity modification is provided by text message delivery three times a week for three months. The intervention is one-way with text message delivery.
Interventions/Control_2
Control group - at the start, knowledge about obesity and the significance of lifestyle modification is provided by brochures.
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) Male workers aged between 18 and 40 years who live in Japan and have a BMI of 25 or more.
2) Have no health problems, other than obesity.
3) Own a smartphone or mobile phone and be able to use a short email service and access the internet.
4) Able to read and write Japanese and understand the research.
5) Have a workplace health check-up.
Key exclusion criteria
1) Working night shifts.
2) Cannot communicate in Japanese.
3) Are receiving regular medical care or have a pre-existing medical condition that prevents them from eating a healthy diet or participating in physical activity and are in hospital.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Tomotake |
Organization
Mejiro University
Division name
Department of Nursing
Zip code
3398501
Address
320 Ukiya,Iwatsukiku, Saitamashi,Saitama
TEL
81487972131
tomotake@mejiro.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tomotake |
Organization
Mejiro University
Division name
Department of Nursing
Zip code
3398501
Address
320 Ukiya,Iwatsukiku, Saitamashi,Saitama
TEL
0787972132
Homepage URL
tomotake@mejiro.ac.jp
Sponsor or person
Institute
Mejiro University
Institute
Department
Personal name
Chie Tomotake
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Mejiro University
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama
Tel
0487972115
univsyomu@mejiro.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
| 2024 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061484
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
