UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042072 |
|---|---|
| Receipt number | R000047936 |
| Scientific Title | A smartphone diet application to support weight loss: A randomized controlled trial |
| Date of disclosure of the study information | 2020/10/10 |
| Last modified on | 2023/04/12 09:06:16 |
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Basic information
Public title
A smartphone diet application to support weight loss: A randomized controlled trial
Acronym
A diet app to support weight loss
Scientific Title
A smartphone diet application to support weight loss: A randomized controlled trial
Scientific Title:Acronym
A diet app to support weight loss
Region
| Japan |
Condition
Condition
Overweight and obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of a smartphone diet application on weight loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Change in body weight over three months
Key secondary outcomes
Changes in the levels of triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, hemoglobin A1c, and fasting plasma glucose; dietary intake; and physical activity over three months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
No intervention
Interventions/Control_2
Use of a smartphone diet application to support weight loss
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those with a body mass index of 23 kg/m2 or more but less than 40 kg/m2
Those who can install the diet application on their smartphones
Office workers who understand the purpose and contents of the study and provide written informed consent
Key exclusion criteria
Those who have a history of heart disease or cerebrovascular disease
Those who are currently pregnant or desire pregnancy during the study
Those who have exhibited significant changes in body weight during the last six months
Those whose cohabiting family member participated in this study
Those who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | NAKATA |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3957
nakata.yoshio.gn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | NAKATA |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3957
Homepage URL
nakata.yoshio.gn@u.tsukuba.ac.jp
Sponsor or person
Institute
Link & Communication Inc.
Institute
Department
Personal name
Funding Source
Organization
Link & Communication Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
029-853-2571
hitorinri@un.tsukuba.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
| 2020 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/14/21/4608
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/14/21/4608
Number of participants that the trial has enrolled
141
Results
The reduced body weight was 2.4 kg and 0.7 kg in the intervention and control groups, respectively. An analysis of covariance adjusted for related variables showed a significant between-group difference in body weight change (p = 0.011).
Results date posted
| 2022 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 02 | Day |
Baseline Characteristics
Intervention group
Age, years: 42.3 (SD 9.4)
Sex (men), n (%): 53 (74)
Body mass index, kg/m2: 27.3 (SD 3.3)
Control group
Age, years: 44.0 (SD 9.1)
Sex (men), n (%): 51 (74)
Body mass index, kg/m2: 27.8 (SD 3.7)
Participant flow
168 enrolled for assessment.
156 assessed for eligibility.
141 were randomized into the intervention group (n = 72) and the control group (n = 69).
One participant in the intervention group discontinued the trial.
The dataset for the remaining 140 participants was included in the primary analysis.
Adverse events
The participants reported no clinically significant adverse events.
Outcome measures
The reduced body weight was 2.4 kg and 0.7 kg in the intervention and control groups, respectively. An analysis of covariance adjusted for related variables showed a significant between-group difference in body weight change (p = 0.011).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047936
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