- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05589155
Efficacy of Using Mobile Health Applications for Health
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92182
- Recruiting
- San Diego State University
-
Contact:
- Mee Young Hong, PhD
- Phone Number: 619-594-2392
- Email: mhong2@sdsu.edu
-
Contact:
- Robert J Castro, BS
- Phone Number: 6193636120
- Email: rcastro0271@sdsu.edu
-
Principal Investigator:
- Mee Young Hong, PhD
-
Principal Investigator:
- Robert J Castro, BS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Healthi
|
Intervention will be with mobile health application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months
Time Frame: 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 |
6 months
|
|
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
Time Frame: 6 months
|
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 |
6 months
|
|
Long term change in diabetes via A1c
Time Frame: 6 months
|
Compare and determine which intervention elicits the most change towards diabetes via HbA1c Outcome measure will be HbA1c |
6 months
|
|
Long term change in diabetes via fasting blood glucose
Time Frame: 6 months
|
Compare and determine which intervention elicits the most change towards diabetes via fasting blood glucose Outcome measure will be fasting blood glucose |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
Time Frame: 6 months
|
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 |
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-2022-0156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.