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Innovative Approaches in Diabetes Care

Primary Purpose

Diabetes Mellitus, Mobile Application, Dietary Assessment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
"3D/AR MetaFood " nutrition education, and receive instant feedback from the nutritionists or AI after recording their dietary food image.
conventional nutrition education by dietitian
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≧20 years old pre-diabetes or diabetes Taiwan nationality or people who can speak Chinese fluently Currently not pregnant or breastfeeding Available to use smartphone to take photos and record food Exclusion Criteria: Eating disorders

Sites / Locations

  • Jung-Su ChangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

eHealth care group

control group

Arm Description

The eHealth group will receive instant feedback from the nutritionists and/or AI after recording their dietary food image, and receive "3D/AR MetaFood" food portion and nutrition education.

The control receive conventional health and nutrition education from state registered dietitian.

Outcomes

Primary Outcome Measures

HbA1c
the change of HbA1c
Fasting glucose
the change of Fasting glucose

Secondary Outcome Measures

Body mass index (kg/m2)
the change of Body mass index
body weight
the change of body weight
Triglyceride (TG)
the change of Triglyceride (TG)

Full Information

First Posted
January 9, 2023
Last Updated
February 12, 2023
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05687968
Brief Title
Innovative Approaches in Diabetes Care
Official Title
Innovative Approaches in Diabetes Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
It is estimated that 2.3 million Taiwanese have diabetes and there is a 44% increased rate among young adults and adolescents. Poor dietary habits and sedentary lifestyle are the major risk factors for type 2 diabetes. The growing availability of smartphones has boosted the development of new technologies that incorporate the use of digital food photography as health promotion and individualized nutrition care. Digital health technology is also used to prevent and treat diabetes with good degree of successes in the short term but the long term effect remains unknown. The broad aim of this study is to evaluate the effectiveness of digital technology eHealth care for diabetic patients. A total of 300 diabetic patients will be recruited from Diabetes Shared Care Network and community care center in Taiwan and follow up 12 months. A simple randomization by computer system will be used to randomly allocate subjects into 2 groups: control group and eHealth care. The control group (n=100) of diabetic patients will receive conventional health and nutrition education from state registered dietitian. The eHealth care group (n=200) of diabetic patients will receive a 10 mins of food portion size nutrition education using " 3D/AR MetaFood platform" and is required to record their consume meal by food image once a week using Taiwan FoodAPP. Patients in the eHealth group will receive instant feedback from the nutritionists or artificial intelligence (AI) for the information of glycemic index (GI) and glycemic load (GL), and educational video related to healthy eating or how to select GI/GL food. Anthropometry, and baseline questionnaires will be collected at baseline. Blood biochemistry (e.g. HbA1c) and body weight will be collected at baseline, 3, 6, 9, and 12 months. The collected food image data will be used for AI training to identify the relationship between the patient's diet and blood glucose changes over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Mobile Application, Dietary Assessment, M-health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eHealth care group
Arm Type
Experimental
Arm Description
The eHealth group will receive instant feedback from the nutritionists and/or AI after recording their dietary food image, and receive "3D/AR MetaFood" food portion and nutrition education.
Arm Title
control group
Arm Type
Experimental
Arm Description
The control receive conventional health and nutrition education from state registered dietitian.
Intervention Type
Behavioral
Intervention Name(s)
"3D/AR MetaFood " nutrition education, and receive instant feedback from the nutritionists or AI after recording their dietary food image.
Intervention Description
The participants record diet images by using Taiwan FoodAPP and receive instant feedback from the nutritionists or AI after recording their dietary food image. The dietitian will use "3D/AR MetaFood food nutrition education platform" to do nutrition education for patients.
Intervention Type
Behavioral
Intervention Name(s)
conventional nutrition education by dietitian
Intervention Description
The participants receive conventional health and nutrition education from state registered dietitian.
Primary Outcome Measure Information:
Title
HbA1c
Description
the change of HbA1c
Time Frame
baseline, 3 month, 6 month, 9 month, 12 month
Title
Fasting glucose
Description
the change of Fasting glucose
Time Frame
baseline, 3 month, 6 month, 9 month, 12 month
Secondary Outcome Measure Information:
Title
Body mass index (kg/m2)
Description
the change of Body mass index
Time Frame
baseline, 3 month, 6 month, 9 month, 12 month
Title
body weight
Description
the change of body weight
Time Frame
baseline, 3 month, 6 month, 9 month, 12 month
Title
Triglyceride (TG)
Description
the change of Triglyceride (TG)
Time Frame
baseline, 3 month, 6 month, 9 month, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≧20 years old pre-diabetes or diabetes Taiwan nationality or people who can speak Chinese fluently Currently not pregnant or breastfeeding Available to use smartphone to take photos and record food Exclusion Criteria: Eating disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Su Chang, PhD.
Phone
886-66382736
Ext
6564
Email
susanchang@tmu.edu.tw
Facility Information:
Facility Name
Jung-Su Chang
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Su Chang, PhD
Phone
886-66382736
Ext
6564
Email
susanchang@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Innovative Approaches in Diabetes Care

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