Diabetes Mellitus, Type 2NCT05279729
Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population
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 the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. 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
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to Dec 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
- 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
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 okay
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
Official title: Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic
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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Mobile health application
- Keywords
- diabetes, low income, 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 two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Weight Watchers (WW) | Experimental | Not described Receives: Other: Mobile health application |
| Healthi app | 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 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)
Measured: 6 months
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
Measured: 6 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
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
Measured: 6 months
Long term diabetes improvement via A1c
Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c
Measured: 6 months
Secondary outcomes (2)
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)
Measured: 6 months
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.
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 posted15 Mar 2022
- Study start1 Aug 2022
- Primary completionOct 2028 (estimated)
- Study completionDec 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
- 45 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
- NCT05279729
- Sponsor's protocol ID
- HS-2021-0245
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 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 mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic
- ClinicalTrials.gov ID
- NCT05279729
- Acronym / sponsor ID
- HS-2021-0245
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- diabetes, low income, mhealth, ehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Mar 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Weight Watchers (WW) | Experimental | Other: Mobile health application |
| Healthi app | Experimental | Other: Mobile health application |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
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 okay
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 two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites) | Other | Healthi app, Weight Watchers (WW) |
Primary outcome
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months
Time frame: 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
Time frame: 6 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
Time frame: 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
Time frame: 6 months
Compare and determine which intervention promotes self-efficacy in weight management
Long term diabetes improvement via A1c
Time frame: 6 months
Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c
2 secondary outcomes
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
Time frame: 6 months
mhealthy app preference assessed by 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
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 8 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 reducing bodyweight assessed by bodyweight measurements over 6 months (time frame: 6 months). The study lists 5 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.