Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population

Obesity Clinical Trial

Official title:

Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279729
• Other study ID #: HS-2021-0245
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 2022

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• Mobile health application
Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)

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 reducing bodyweight assessed by bodyweight measurements over 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)	6 months
Primary	Most effect intervention for weight loss in first 3 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	6 months
Primary	Most effective intervention for weight loss by 6 months	Compare and determine which intervention leads to the highest weight loss maintenance after six months	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	6 months
Primary	Long term diabetes improvement via A1c	Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c	6 months
Secondary	Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire	Comparing the three interventions to determine which leads to greater quality of life (QOL)	6 months
Secondary	mhealthy app preference assessed by questionnaire	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.	6 months