Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
diabetes, low income, mhealth, ehealth
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.
Interventions
Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)
Sponsors
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Most effect intervention for weight loss in first 3 months | 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 |
| Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire | 6 months | Compare and determine which intervention promotes self-efficacy in weight management |
| Long term diabetes improvement via A1c | 6 months | Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c |
| Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months | 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 effective intervention for weight loss by 6 months | 6 months | Compare and determine which intervention leads to the highest weight loss maintenance after six months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mhealthy app preference assessed by questionnaire | 6 months | 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. |
| Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire | 6 months | Comparing the three interventions to determine which leads to greater quality of life (QOL) |
Countries
United States
Outcome results
None listed