Efficacy of Using Mobile Health Applications for Health

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 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.

Official Title
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Efficacy of Using Mobile Health Applications for Health

Conditions
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Obesity, Diabetes Mellitus, Type 2

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 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

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: Healthi<br> | Other: Mobile health application<br>* Intervention will be with mobile health application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 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 | 

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