Efficacy of Using Mobile Health Applications for Health

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Other: Mobile health application

• Registration Number: NCT05589155
• Lead Sponsor: San Diego State University

Brief 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 their blood glucose readings daily before and after meals for at least three meals in the day.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-16
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Healthi	Mobile health application	-

Primary Outcome Measures

Name	Time	Method
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.; Reporting will be on a scale of 0-100, with higher scores indicating higher self-efficacy
Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months	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
Long term change in diabetes via A1c	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	6 months	Compare and determine which intervention elicits the most change towards diabetes via fasting blood glucose; Outcome measure will be fasting blood glucose

Secondary Outcome Measures

Name	Time	Method
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire	6 months	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

Trial Locations

Locations (1)

San Diego State University; 🇺🇸 San Diego, California, United States