UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053570 |
|---|---|
| Receipt number | R000061127 |
| Scientific Title | PILOT EVALUATION OF INTEGRATING A PERSONALIZED PROMPT GENERATOR WITH AN ARTIFICIAL INTELLIGENCE CHATBOT FOR DIETARY AND EXERCISE PLANNING: FEASIBILITY AND OUTCOMES IN WEIGHT MANAGEMENT FOR OBESE ADULTS |
| Date of disclosure of the study information | 2024/02/08 |
| Last modified on | 2024/02/07 19:21:37 |
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Basic information
Public title
Feasibility and Outcomes of Integrating a Personalized Prompt Generator with an AI Chatbot for Dietary and Exercise Planning in Weight Management Among Obese Adults: A Pilot Study
Acronym
NExGEN
Scientific Title
PILOT EVALUATION OF INTEGRATING A PERSONALIZED PROMPT GENERATOR WITH AN ARTIFICIAL INTELLIGENCE CHATBOT FOR DIETARY AND EXERCISE PLANNING: FEASIBILITY AND OUTCOMES IN WEIGHT MANAGEMENT FOR OBESE ADULTS
Scientific Title:Acronym
NExGEN-Obese
Region
| Asia(except Japan) |
Condition
Condition
Obese population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the level of user experience and adoption factors following three month usage of NExGEN ChatGPT system in weight management for obese adults
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between engagement rate, perceived satisfaction, and adherence level following three month usage of NExGEN ChatGPT system in weight management for obese adults.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Data on engagement rate, perceived satisfaction, adherence level, and body weight following three month intervention with NExGEN ChatGPT system in weight management for obese adults
Key secondary outcomes
Data on the recorded physical activity and movement from the waist mounted accelerometer, waist circumference and resting blood pressure following three month intervention with NExGEN ChatGPT system in weight management for obese adults
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Dietary intake, Exercise, and other lifestyle modifications.
Interventions/Control_2
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) BMI equal or more than 27.5
(2) Literate in English or Malay
(3) Free from physical injury
(4) Own a scale to obtain their body weight at home,
(5) Have access to a smartphone, computer or tablet with internet access.
Key exclusion criteria
(1) Recent weight loss
(2) Taking weight loss drugs
(3) Diagnosed with insulin-dependent diabetes or cardiovascular disease
(4) Cognitive impairment or histories of psychiatric disorders
(5) Having other conditions or situation that may interfere with the participation and ability to follow the intervention protocol
(6) Physical impairment disallowing them to perform moderate physical activity.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Adam |
| Middle name | |
| Last name | Linoby |
Organization
Universiti Teknologi MARA
Division name
Faculty of Sports Science and Recreation
Zip code
70300
Address
UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri Sembilan, Malaysia
TEL
+60133632005
linoby@uitm.edu.my
Public contact
Name of contact person
| 1st name | Adam |
| Middle name | |
| Last name | Linoby |
Organization
Universiti Teknologi MARA
Division name
Faculty of Sports Science and Recreation
Zip code
70300
Address
UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri
TEL
+60133632005
Homepage URL
https://seremban.uitm.edu.my/
linoby@uitm.edu.my
Sponsor or person
Institute
Universiti Teknologi MARA
Institute
Department
Personal name
Funding Source
Organization
Universiti Teknologi MARA
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Malaysia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universiti Teknologi MARA
Address
UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri
Tel
6066342359
wahidah06@uitm.edu.my
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
Universiti Teknologi MARA (UiTM)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 08 | 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
34
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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 05 | 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 | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061127
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