Efficacy of Using Mobile Health Applications for Health

Obesity Clinical Trial

Official title:

Efficacy of Using Mobile Health Applications for Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589155
• Other study ID #: HS-2022-0156
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2022
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• Mobile health application
Intervention will be with mobile health application

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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