Back to resultsEfficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population
Primary Purpose
Diabetes Mellitus, Type 2, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile health application
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, low income, mhealth, ehealth
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with type II diabetes
- Between the age of 18-64
- BMI ≥ 27
- Individual annual income less than $47,520 [Covered CA income guidelines and salary restrictions]
- Hispanic and/or Latinx origin
- Monitors blood glucose regularly
- Owns or has access to a bathroom weight scale
- Owns a smartphone and willing to download mobile apps
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 okay
Sites / Locations
- San Diego State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Weight Watchers (WW)
Healthi app
Arm Description
Outcomes
Primary Outcome Measures
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months
Determine if mHealth apps-Weight Watchers (WW) and Healthi app-are an effective weight loss modality compared to standard weight loss program (control)
Most effect intervention for weight loss in first 3 months
Compare the three interventions, mHealth apps and control, against each other to determine which is most effective at achieving the maximum amount of weight loss within the first three months
Most effective intervention for weight loss by 6 months
Compare and determine which intervention leads to the highest weight loss maintenance after six months
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
Compare and determine which intervention promotes self-efficacy in weight management
Long term diabetes improvement via A1c
Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c
Secondary Outcome Measures
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
Comparing the three interventions to determine which leads to greater quality of life (QOL)
mhealthy app preference assessed by questionnaire
Which mHealth app is more economically feasible for the participants and if feasibility changes after app usage. Outcome will be assessed with a questionnaire asking if the participant can afford the app.
Full Information
NCT ID
NCT05279729
First Posted
February 23, 2022
Last Updated
October 16, 2022
Sponsor
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT05279729
Brief Title
Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population
Official Title
Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (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 the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. 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, low income, mhealth, ehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Weight Watchers (WW)
Arm Type
Experimental
Arm Title
Healthi app
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mobile health application
Intervention Description
Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)
Primary Outcome Measure Information:
Title
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months
Description
Determine if mHealth apps-Weight Watchers (WW) and Healthi app-are an effective weight loss modality compared to standard weight loss program (control)
Time Frame
6 months
Title
Most effect intervention for weight loss in first 3 months
Description
Compare the three interventions, mHealth apps and control, against each other to determine which is most effective at achieving the maximum amount of weight loss within the first three months
Time Frame
6 months
Title
Most effective intervention for weight loss by 6 months
Description
Compare and determine which intervention leads to the highest weight loss maintenance after six months
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
Time Frame
6 months
Title
Long term diabetes improvement via A1c
Description
Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c
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 three interventions to determine which leads to greater quality of life (QOL)
Time Frame
6 months
Title
mhealthy app preference assessed by questionnaire
Description
Which mHealth app is more economically feasible for the participants and if feasibility changes after app usage. Outcome will be assessed with a questionnaire asking if the participant can afford the app.
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
Between the age of 18-64
BMI ≥ 27
Individual annual income less than $47,520 [Covered CA income guidelines and salary restrictions]
Hispanic and/or Latinx origin
Monitors blood glucose regularly
Owns or has access to a bathroom weight scale
Owns a smartphone and willing to download mobile apps
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 okay
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
Learn more about this trial
Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population
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