Efficacy of Using Mobile Health Applications for Health

Sponsor

San Diego State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05589155

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Obesity	Other: Mobile health application	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy of Using Mobile Health Applications for Health

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control
Experimental: Healthi	Other: Mobile health application Intervention will be with mobile health application

Arm

Intervention/Treatment

No Intervention: Control

Experimental: Healthi

Other: Mobile health application

Intervention will be with mobile health application

Outcome Measures

Primary Outcome Measures

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
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
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego State University	San Diego	California	United States	92182

Sponsors and Collaborators

San Diego State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Castro, Principal investigator, San Diego State University

ClinicalTrials.gov Identifier:

NCT05589155

Other Study ID Numbers:

HS-2022-0156

First Posted:

Oct 21, 2022

Last Update Posted:

Oct 21, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Robert Castro, Principal investigator, San Diego State University

diabetes

mhealth

ehealth

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 21, 2022