Diabetes Mellitus, Type 2NCT05589155
Efficacy of Using Mobile Health Applications for Health
A study testing Mobile health application in people with Diabetes Mellitus, Type 2 and Obesity, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Mobile health application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92182
Mee Young Hong, PhD, 6195942392, mhong2@sdsu.edu
Robert J Castro, BS, 6193636120, rcastro0271@sdsu.edu
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Mobile health application
- Keywords
- diabetes, mhealth, ehealth
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health applicationOther
Intervention will be with mobile health application
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Healthi | Experimental | Not described Receives: Other: Mobile health application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 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.
Reporting will be on a scale of 0-100, with higher scores indicating higher self-efficacy
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589155
- Sponsor's protocol ID
- HS-2022-0156
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Using Mobile Health Applications for Health
- ClinicalTrials.gov ID
- NCT05589155
- Acronym / sponsor ID
- HS-2022-0156
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- diabetes, mhealth, ehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Healthi | Experimental | Other: Mobile health application |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health applicationIntervention will be with mobile health application | Other | Healthi |
Primary outcome
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
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
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
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
1 secondary outcome
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health application in people with Diabetes Mellitus, Type 2 and Obesity, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.