Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Other: Mobile health application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Weight Watchers (WW)<br> | Other: Mobile health application<br>* Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)<br>|
| Experimental: Healthi app<br> | Other: Mobile health application<br>* Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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 | 6 months | 
| Long term diabetes improvement via A1c | Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c | 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 | Comparing the three interventions to determine which leads to greater quality of life (QOL) | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, low income, mhealth, ehealth