UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053478 |
|---|---|
| Receipt number | R000061040 |
| Scientific Title | Effectiveness of an Online Interventions to Promote Postpartum Physical Activity: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2025/04/26 16:22:27 |
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Basic information
Public title
Online Physical Activity Promotion Program for Postpartum Women
Acronym
Online Physical Activity Promotion Program for Postpartum Women
Scientific Title
Effectiveness of an Online Interventions to Promote Postpartum Physical Activity: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of an Online Interventions to Promote Postpartum Physical Activity: RCT
Region
| Japan |
Condition
Condition
No disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examin the effectiveness of an 8-week online physical activity program intervention developed to promote physical activity and health among postpartum women by conducting a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The amount of physical activity
Physical activity is measured over a 7-day period, excluding sleeping and bathing, using an activity meter with a built-in 3-axis acceleration sensor.
Key secondary outcomes
Body composition
Health related quality of life (SF-12v2: Short-form health survey version-2.0)
The Profile of Mood States (POMS 2-SF: Short-form of profile of mood states second edition)
Stages of change for exercise behavior
Self-efficay for exercise
The perceived positive and negative aspects of exercise
Body dissatisfaction (EDI-BD: Eating disorder inventory-body dissatisfaction)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participate in a 2-month online program (6 sessions totaling 80 minutes each) to learn body self-care and exercise in the 3-5 months postpartum.
Interventions/Control_2
Participate in a 2-month online program (6 sessions totaling 80 minutes each) to learn body self-care and exercise in the 3-5 months postpartum.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Postmartum women over 20 years old
Women who can answer the self-administered questionnaire in Japanese and participate in the program.
3-5 months postpartum at the start of the program
Having a device and network environment to participate in the online program
Those who are allowed to return to a normal lifestyle (including exercise) at the 1-month postpartum checkup
Key exclusion criteria
Those who are undergoing treatment or visiting the hospital due to a disease
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Nomura |
Organization
Chiba Institute of Technology
Division name
Faculty of Creative Engineering, Center for Liberal Arts
Zip code
275-0023
Address
1-2-2, Shibazono, Narashino, Chiba
TEL
047-454-9658
yumi.nomura@p.chibakoudai.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Nomura |
Organization
Chiba Intitute of Technology
Division name
Faculty of Creative Engineering, Center for Liberal Arts
Zip code
275-0023
Address
2-1-1 Shibazono, Narashino, Chiba
TEL
047-454-9658
Homepage URL
https://activemomproject.my.canva.site/dafyuad-ksk
yumi.nomura@p.chibakoudai.jp
Sponsor or person
Institute
Chiba Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Support, Center for Teaching and Learning, Chiba Institute of Technology
Address
2-17-1, Tsudanuma, Narashino, Chiba, 275-0016
Tel
047-478-0325
sankan-box@it-chiba.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
千葉工業大学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 31 | 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
180
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061040
