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Efficacy of Using Mobile Health Applications for Health

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile health application
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, mhealth, ehealth

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosed with type II diabetes for at least 3 months
  • Between the age of 18-64
  • BMI ≥ 25
  • Monitors blood glucose regularly (at least once per day)
  • Owns or has access to a bathroom weight scale
  • Owns a smartphone and willing to download mobile app

Exclusion Criteria:

  • Does not check blood glucose at least once per day
  • On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.

Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are oka

Sites / Locations

  • San Diego State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Healthi

Arm Description

Outcomes

Primary Outcome Measures

Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months
Determine if mhealth app is an effective weight loss modality compared to standard weight loss program (control) Outcome measure will be body weight in kg
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
Compare and determine which intervention promotes self-efficacy in weight management. Reporting will be on a scale of 0-100, with higher scores indicating higher self-efficacy
Long term change in diabetes via A1c
Compare and determine which intervention elicits the most change towards diabetes via HbA1c Outcome measure will be HbA1c
Long term change in diabetes via fasting blood glucose
Compare and determine which intervention elicits the most change towards diabetes via fasting blood glucose Outcome measure will be fasting blood glucose

Secondary Outcome Measures

Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
Comparing the two arms to determine which leads to greater quality of life (QOL) Measures will be reported on a scale of 1-5 across four domains. Scores will be converted to a scale of 0-100

Full Information

First Posted
October 16, 2022
Last Updated
October 18, 2022
Sponsor
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT05589155
Brief Title
Efficacy of Using Mobile Health Applications for Health
Official Title
Efficacy of Using Mobile Health Applications for Health
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and type II diabetes outcomes in type 2 diabetics. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
diabetes, mhealth, ehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Healthi
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mobile health application
Intervention Description
Intervention will be with mobile health application
Primary Outcome Measure Information:
Title
Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months
Description
Determine if mhealth app is an effective weight loss modality compared to standard weight loss program (control) Outcome measure will be body weight in kg
Time Frame
6 months
Title
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
Description
Compare and determine which intervention promotes self-efficacy in weight management. Reporting will be on a scale of 0-100, with higher scores indicating higher self-efficacy
Time Frame
6 months
Title
Long term change in diabetes via A1c
Description
Compare and determine which intervention elicits the most change towards diabetes via HbA1c Outcome measure will be HbA1c
Time Frame
6 months
Title
Long term change in diabetes via fasting blood glucose
Description
Compare and determine which intervention elicits the most change towards diabetes via fasting blood glucose Outcome measure will be fasting blood glucose
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
Description
Comparing the two arms to determine which leads to greater quality of life (QOL) Measures will be reported on a scale of 1-5 across four domains. Scores will be converted to a scale of 0-100
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with type II diabetes for at least 3 months Between the age of 18-64 BMI ≥ 25 Monitors blood glucose regularly (at least once per day) Owns or has access to a bathroom weight scale Owns a smartphone and willing to download mobile app Exclusion Criteria: Does not check blood glucose at least once per day On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications. Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are oka
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mee Young Hong, PhD
Phone
619-594-2392
Email
mhong2@sdsu.edu
First Name & Middle Initial & Last Name & Degree
Robert J Castro, BS
Phone
6193636120
Email
rcastro0271@sdsu.edu
First Name & Middle Initial & Last Name & Degree
Mee Young Hong, PhD
First Name & Middle Initial & Last Name & Degree
Robert J Castro, BS

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Using Mobile Health Applications for Health

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