UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055142 |
|---|---|
| Receipt number | R000060673 |
| Scientific Title | Evaluation of a Smartphone-Based Weight Loss Intervention with Phone Call Support for Merchant Women with Obesity in Cote d'Ivoire: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/08/04 17:36:06 |
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Basic information
Public title
A Smartphone-Based Weight Loss Program with Phone Support for Women with Obesity in Cote d'Ivoire
Acronym
Weight loss program for obese woman merchants in Cote d'Ivoire
Scientific Title
Evaluation of a Smartphone-Based Weight Loss Intervention with Phone Call Support for Merchant Women with Obesity in Cote d'Ivoire: A Randomized Controlled Trial
Scientific Title:Acronym
Impact of a Weight Loss Program for Obese Woman Merchants in Cote d'Ivoire
Region
| Africa |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the impact and feasibility of a smartphone-based weight loss program for obese women working in a market in Cote d'Ivoire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body weight
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Face-to-face 5-minute health education (at the beginning of the intervention, after 3 months, and after 6 months)
Distribution of weighing scales
Installation and orientation of a weight recording application
Self-recording of weight into the smartphone application
Reminder of weekly weight recording and provision of health education message in group chat
Monthly phone call to monitor status and remind to weigh in
Interventions/Control_2
No Intervention
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
BMI 30 and above
Aged 18 to 64 years old
Women working in the target market
Having a smartphone and access to own WhatsApp account
Those who understand about the study and agree to participate in the study on their own will.
Key exclusion criteria
Pregnant or lactating women
Those whose pregnancy is detected during the study period
Those who have been instructed by a health care provider that weight loss is contraindicated
Those who are using a weight loss medicine prescribed by a medical practitioner
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Kanoya |
Organization
Yokohama city university
Division name
Graduate School of Medicine, Nursing
Zip code
236-0004
Address
3-9,fukuura, kanazawa-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL
045-787-2542
ykano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | Usui |
Organization
Yokohama city university
Division name
Graduate School of Medicine, Nursing
Zip code
236-0004
Address
3-9,fukuura, kanazawa-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL
045-787-2542
Homepage URL
usuir@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research, 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
Yokohama City University Clinical Ethics Committee
Address
5F Yokohama-Kanazawa High-Tech Center, Techno Core, 1-1-1 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
045-370-7627
rinri@yokohama-cu.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
コートジボワール、アビジャン、アノノ市場
Other administrative information
Date of disclosure of the study information
| 2024 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2026 | Year | 05 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060673
